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1.  Current practice in pharyngeal pouch surgery in England and Wales. 
A survey of the current surgical practice for patients with a pharyngeal pouch was conducted among general surgeons, otolaryngologists and cardiothoracic surgeons in England and Wales. Our results show that while pouch excision remains the most common method used, endoscopic stapling diverticulotomy is rapidly being adopted. The reasons why this recently introduced technique is likely to become the definitive treatment of pharyngeal pouch are discussed.
PMCID: PMC2502907  PMID: 9196339
2.  Pharyngeal pouch (Zenker's diverticulum) 
Postgraduate Medical Journal  2001;77(910):506-511.
Pharyngeal pouches occur most commonly in elderly patients (over 70 years) and typical symptoms include dysphagia, regurgitation, chronic cough, aspiration, and weight loss. The aetiology remains unknown but theories centre upon a structural or physiological abnormality of the cricopharyngeus. A diagnosis is easily established on barium studies. Treatment is surgical via an endoscopic or external cervical approach and should include a cricopharyngeal myotomy. Unfortunately pharyngeal pouch surgery has long been associated with significant morbidity, partly due to the surgery itself and also to the fact that the majority of patients are elderly and often have general medical problems. External approaches are associated with higher complication rates than endoscopic procedures. Recently, treatment by endoscopic stapling diverticulotomy has becoming increasingly popular as it has distinct advantages, although long term results are not yet available. The small risk of developing carcinoma within a pouch that is not excised remains a contentious issue and is an argument for long term follow up or treating the condition by external excision, particularly in younger patients.

Keywords: Zenker's diverticulum; surgical procedures: endoscopic; surgical stapling
PMCID: PMC1742115  PMID: 11470929
3.  Endoscopic stapling diverticulotomy of pharyngeal pouch. 
Endoscopic diverticulotomy (Dohlman's procedure) is a well-established and effective alternative to external diverticulectomy in the treatment of pharyngeal pouch. The division of the common septum between the pouch and the oesophagus is usually performed either with electrocautery or with a laser. We describe a new technique of endoscopic diverticulotomy using a linear cutter stapling gun. This technique has the advantages of being quick and bloodless, avoiding the need for a nasogastric tube, permitting oral intake as early as the first postoperative day and allowing early discharge from hospital. It also has the theoretical advantage over the electrocautery or the laser technique of reducing the risk of fistula formation, mediastinitis and thermal injury to the recurrent laryngeal nerve.
PMCID: PMC2502556  PMID: 8678451
4.  A retrospective review of pharyngeal pouch surgery in 56 patients. 
We retrospectively reviewed 56 consecutive patients treated surgically for a pharyngeal pouch at our institution between 1989-1999 (10 years). Various surgical procedures were performed including endoscopic stapling (20), external excision (23), Dohlman's procedure (9), pouch inversion (3), cricopharyngeal myotomy only (3), and pouch suspension (1). There were 12 patients (18%) with complications and one mortality (2%). Four patients (7%) had a recurrence with 2 requiring further surgery. Over the latter 3 years, endoscopic stapling has emerged as the primary procedure for pharyngeal pouch surgery in our unit; with the advantages of an earlier commencement of diet and earlier hospital discharge. However, results were not as good as for external excisions. Furthermore, there were difficulties with 3 cases that commenced as endoscopic stapling procedures but had to he converted to external excisions due to inaccessibility in one case and iatrogenic perforations in two cases. As with any new technique, problems may occur and a learning curve has been appreciated in our unit. Surgeons must he prepared, with informed consent, to convert to an external approach should difficulties arise during endoscopic stapling. Elderly and frail patients who are at risk from a general anaesthetic may benefit from endoscopic stapling. External excision of pharyngeal pouches may be more appropriate in the young, the medically fit, and when malignancy is a concern.
PMCID: PMC2504214  PMID: 12215027
5.  UK survey of the present role of ear, nose and throat surgeons in lacrimal surgery 
The objective of this study was to evaluate the current involvement of ear, nose and throat (ENT) surgeons in lacrimal surgery.
A postal survey was distributed to 796 practicing UK consultant otorhinolaryngologists listed at the drfoster website.
Overall, 531 questionnaires were returned, giving a response rate of 66.7%. Of these, 108 (20.6%) respondents indicated they were involved in lacrimal surgery. The majority of otolaryngologists seem to work in collaboration with ophthalmologists. In our survey, 98% (106) perform endoscopic dacryocystorhinostomy (DCR). Most respondents believed lacrimal intubation and dilation to have limited success, endoscopic DCR to have moderate success and external DCR to have high success.
Lacrimal surgery is carried out in a spirit of collaboration with ophthalmologists rather than competition. Endoscopic DCR is the favoured surgical procedure of otolaryngologists. The perceived success rate for endoscopic DCR reported in this survey coincides with that reported in the literature.
PMCID: PMC3229349  PMID: 20633321
Lacrimal surgery; Endoscopic dacryocystorhinostomy; External dacryocystorhinostomy
6.  Vestibular Schwannoma Management: Current Practice Amongst UK Otolaryngologists – Time for a National Prospective Audit 
It is generally agreed that the successful management of a vestibular schwannoma (VS) usually involves close collaboration between a neuro-otologist and neurosurgeon. In addition, it is accepted that the experience of the team managing such tumours is one of the key determinants of outcome after surgical intervention. The aim of this study was to identify current practice in the management of such tumours amongst otolaryngologists in the UK and to observe whether such collaborative working practices exist.
A cross sectional postal questionnaire survey of consultant members of the British Association of Otorhinolaryngologists – Head and Neck Surgeons (n = 542).
A total of 336 replies were received (62%). Of respondents, 299 consultants referred their patients to another surgeon for further management; 242 referred to another ENT surgeon (80.9%), 29 to a neurosurgeon (9.7%) and 28 to a combined team (9.4%). Twenty-eight of the responding otolaryngologists (8.6%) managed the tumours themselves, of whom 22 worked with a neurosurgeon. Of these 28 neuro-otologists, nearly two-thirds (64%) had been undertaking VS surgery for more than 10 years. The total number of patients with a VS referred to these 28 consultants during 2001 was 775, with a mean caseload of 29.8, median 23 and a range of 4 to 102 per surgeon. Seven of the 28 otolaryngologists chose their surgical approach entirely based on the size of the tumour. Eight consultants preferred the sub-occipital (SO) approach, 10 the trans-labyrinthine (TL) approach, three chose between SO and TL approaches. The majority of surgeons had a prospective, computer-based data collection and were willing to give further information about their outcomes and complications.
Amongst the otolaryngologists surveyed in the UK, we have identified 28 neuro-otologists who undertake VS surgery. The majority work with neurosurgical colleagues, confirming collaborative practice. The wide range in caseload raises the issue of training and maintaining standards and in the first instance we recommend a prospective national audit of VS management and outcomes with our neurosurgical colleagues. This would also be of value in manpower planning particularly if a minimum caseload could be identified below which results were seen to be less good.
PMCID: PMC1964657  PMID: 17002858
Vestibular schwannoma; Acoustic neuroma; Audit; Management; Collaboration
7.  Zenker's Diverticulum: Carbon Dioxide Laser Endoscopic Surgery 
BioMed Research International  2014;2014:516231.
Nowadays endoscopic diverticulotomy is the surgical approach of the first choice in treatment of Zenker's diverticulum. We report our experience with this procedure and try to sum up recent recommendations for management of surgery and postoperative care. Data of 34 patients with Zenker's diverticulum, treated by endoscopic carbon dioxide laser diverticulotomy at the Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine, Charles University, University Hospital Motol, Prague, Czech Republic, were prospectively stored and followed in relatively short period from May 2009 to December 2013. The average length of diverticulum was 32 mm. The average duration of surgery was 32 min. The patients were fed via feeding tube for 6.1 days and antibiotics were administered for 7 days. Mean hospitalization time was 7.4 days. We observed one transient recurrent laryngeal nerve paralysis and no other serious complications. Recurrence rate was 3%. We recommend complete transection of the diverticular septum in one procedure, systemic antibiotic treatment and exclusion of transoral intake for minimally 5 days, and contrast oesophagogram before resumption of oral intake to exclude fistula. Open diverticulectomy should be reserved for cases with inadequate endoscopic exposure and for revision surgery for multiple recurrences from endoscopic diverticulotomies.
PMCID: PMC3963375  PMID: 24729975
8.  Subsequent Adenomas of Ileal Pouch and Anorectal Segment after Prophylactic Surgery for Familial Adenomatous Polyposis 
Familial adenomatous polyposis (FAP) is an autosomally dominant disease characterized by the early development of colorectal adenomas and carcinoma in untreated patients. Patients with FAP may develop rectal cancer at their initial presentation (primary) or after prophylactic surgery (secondary). Controversies exist regarding which surgical procedure represents the best first-line treatment. The options for FAP are ileorectal anastomosis (IRA) or a restorative proctocolectomy (RPC) with either a handsewn or a stapled ileal pouch-anal anastomosis (IPAA), with or without mucosectomy. The purpose of these surgeries is to stop progression to an adenoma-cancer sequence by eradicating the colon, a disease prone organ. Unfortunately, these surgical procedures, which excise the entire colon and rectum while maintaining transanal fecal continence, do not guarantee that patients still won't develop adenomas. Based on the available literature, we therefore reviewed reported incidences of pouch-related adenomas that occurred post prophylactic surgery for FAP. The review consists of a collection of case, descriptive, prospective and retrospective reports.
To provide available data on the natural history of subsequent adenomas after prophylactic surgery (by type) for FAP.
A review was conducted of existing case, descriptive, prospective and retrospective reports for patients undergoing prophylactic surgery for FAP (1975 – August, 2013). In each case, the adenomas were clearly diagnosed in one of the following: the ileal pouch mucosa (above the ileorectal anastomosis), within the anorectal segment (ARS) below the ileorectal anastomosis, or in the afferent ileal loop.
A total of 515 (36%) patients with pouch-related adenomas have been reported. Two hundred and eleven (211) patients had adenomas in the ileal pouch mucosa, 295 had them in the ARS and in 9 were in the afferent ileal loop. Patients with pouch adenomas without dysplasia or cancer were either endoscopically polypectomized or were treated with a coagulation modality using either a Nd:Yag laser or argon plasma coagulation (as indicated). Patients with dysplastic pouch adenomas or pouch adenomas with cancer had their pouch excised (pouchectomy).
In patients with FAP treated with IRA or RPC with IPAA, the formation of adenomas in the pouch-body mucosa or ARS/anastomosis and in the afferent ileal loop is apparent. Because of risks for adenoma recurrence, a life time endoscopic pouch-surveillance is warranted.
PMCID: PMC4012278  PMID: 24817992
Familial-adenomatous polyposis; restorative proctocolectomy; ileal-anal pouch anastomosis; ileorectal anastomosis; adenomas
9.  Zenker's diverticulum: exploring treatment options 
Zenker's diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula with a reported prevalence ranging between 0.01 to 0.11% and typically occurs in middle-aged and elderly patients. Predominant symptoms are dysphagia and regurgitation. Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques. Management of Zenker's diverticulum has dramatically progressed during past decades. Open surgery with cricopharyngeal myotomy has long been the conventional treatment with satisfactory results, but is associated with high complication rates. Since Zenker's diverticulum mainly affects frail elderly patients, less invasive treatments are indicated. In recent years, endoscopic repair of Zenker's diverticulum has been found to be a viable safe and effective alternative to surgery and gained widespread acceptance. Endoscopic stapled diverticulotomy is generally the preferred approach, but flexible endoscopy is a valuable option, particularly for high-risk patients. The literature is mainly based on retrospective case series or comparative case series, and the optimal treatment modality has not yet been established. The choice between the different approaches depends on local expertise and preferences. Based on retrospective literature results, appropriate technique selection dictated by the size of the diverticulum and the patient's conditions is however desirable.
PMCID: PMC3773964  PMID: 24043908
Zenker's diverticulum; Cricopharyngeal muscle; Myotomy; Diverticulectomy; Endoscopic stapling diverticulotomy; Flexible endoscopy
10.  Pouch-related dysplasia and adenocarcinoma following restorative proctocolectomy for ulcerative colitis 
Techniques in coloproctology  2011;15(1):7-16.
Restorative proctocolectomy (RPC) is the criterion standard surgical treatment for ulcerative colitis (UC). Restorative proctocolectomy is indicated for UC that is refractory to medical treatment, for emergency conditions, and in case of neoplastic transformation. The procedure substantially reduces the risk of UC-associated dysplasia/neoplasia. However, after RPC surgery, even with mucosectomy, cancers of the pouch and/or the anal-transitional zone (ATZ) have been reported with increasing frequency since the first report in 1984. This review highlights pouch-related dysplastic and neoplastic transformation, prevalence and adverse events, risk factors and surveillance following surgery for UC.
Reports in the literature about patients undergoing pouch surgery from different institutions reported through May 2010 were reviewed to identify patients who developed these complications, and an attempt was made to develop a rational follow-up policy based on the data available.
To date, there are 43 reported cancers of the pouch or inlet after RPC for UC: 16 from retrospective series, 1 from a prospective study, and 26 in case reports. Thirty patients underwent mucosectomy and 13 had stapled anastomoses. To date, the number of 28 patients has been diagnosed with dysplasia after RPC for UC. Mucosectomy was performed in 27 of them and in 1 a stapled anastomosis was constructed without mucosectomy. In all cases reviewed, the time interval from the onset of UC to dysplasia/neoplasia was over 10 years.
Neoplastic lesions occurring in UC patients after RPC have been shown to be absolutely inevitable. Even mucosectomy does not completely eliminate the risk. There is little evidence to support routine biopsy of the ileal mucosa or the anal-transition zone except in patients with histological type C changes, sclerosing cholangitis, and unremitting pouchitis in the ileal mucosa. Such patients should be selected for endoscopic surveillance to detect dysplasia preceding pouch adenocarcinoma.
PMCID: PMC4086905  PMID: 21287223
Ulcerative colitis; Restorative proctocolectomy; Mucosectomy/stapled anastomosis; Dysplasia/adenocarcinoma etiology
11.  Complications after ileal pouch-anal anastomosis in Korean patients with ulcerative colitis 
AIM: To investigate the outcomes of treatments for complications after ileal pouch-anal anastomosis (IPAA) in Korean patients with ulcerative colitis.
METHODS: Between March 1998 and February 2013, 72 patients (28 male and 44 female, median age 43.0 years ± 14.0 years) underwent total proctocolectomy with IPAA. The study cohort was registered prospectively and analyzed retrospectively. Patient characteristics, medical management histories, operative findings, pathology reports and postoperative clinical courses, including early postoperative and late complications and their treatments, were reviewed from a medical record system. All of the ileal pouches were J-pouch and were performed with either the double-stapling technique (n = 69) or a hand-sewn (n = 3) technique.
RESULTS: Thirty-one (43.1%) patients had early complications, with 12 (16.7%) patients with complications related to the pouch. Pouch bleeding, pelvic abscesses and anastomosis ruptures were managed conservatively. Patients with pelvic abscesses were treated with surgical drainage. Twenty-seven (38.0%) patients had late complications during the follow-up period (82.5 ± 50.8 mo), with 21 (29.6%) patients with complications related to the pouch. Treatment for pouchitis included antibiotics or anti-inflammatory drugs. Pouch-vaginal fistulas, perianal abscesses or fistulas and anastomosis strictures were treated surgically. Pouch failure developed in two patients (2.8%). Analyses showed that an emergency operation was a significant risk factor for early pouch-related complications compared to elective procedures (55.6% vs 11.1%, P < 0.05). Pouchitis was related to early (35.3%) and the other late pouch-related complications (41.2%) (P < 0.05). The complications did not have an effect on pouch failure nor pouch function.
CONCLUSION: The complications following IPAA can be treated successfully. Favorable long-term outcomes were achieved with a lower pouch failure rate than reported in Western patients.
PMCID: PMC4064095  PMID: 24966620
Ulcerative colitis; Ileal pouch-anal anastomosis; Complications; Pouch failure; Pouch function
12.  Long-term outcome and quality of life after transoral stapling for Zenker diverticulum 
AIM: To investigate long-term results and quality of life after transoral stapling of Zenker diverticulum.
METHODS: The data of all patients admitted to our institution for the surgical treatment of Zenker diverticulum were entered into a prospective database. Demographics, symptoms, intraoperative and postoperative data, morbidity, time to oral feeding, and length of hospital stay were recorded. All patients underwent upper gastrointestinal endoscopy and a barium swallow study to measure the length of the diverticulum from the apex of the septum to the bottom of the pouch. Transoral stapling was performed using a Weerda diverticuloscope under general anesthesia. Over time, the technique was modified by applying traction sutures to ease engagement of the common septum inside the stapler jaws. Perioperative variables, symptoms, long-term outcome, and quality of life were analyzed. The operation was considered successful if the patient reported complete remission (grade 1) or marked improvement (grade 2) of dysphagia, regurgitation, and respiratory symptoms. Statistical analysis was performed using Statistical Package for Social Science (SPSS, Version 15, SPSS, Inc., Chicago, IL).
RESULTS: Between 2001 and 2013, the transoral approach was successfully completed in 100 patients with a median age of 75 years. Patients with a larger (≥ 3 cm) diverticulum were older than those with a smaller pouch (P < 0.038). Complications occurred in 4% of the patients but there was no mortality. A statistically significant improvement of dysphagia and regurgitation scores (P < 0.001) was recorded over a median follow-up of 63 mo. Similarly, a significant decrease in the median number of pneumonia episodes per year (P < 0.001) was recorded after surgery. The overall long-term success rate of the procedure was 76%. The success rate of the operation was greater in patients of 70 years of age or older compared to younger individuals (P = 0.038). Use of traction sutures on the septum was associated with an improved success rate compared with the standard procedure (P = 0.04). All items of the health related quality of life questionnaire were significantly higher compared to baseline (P < 0.05).
CONCLUSION: Transoral stapling is safe and effective. The operation significantly improves patients’ quality of life. It appears that elderly patients with large diverticula significantly benefit from the procedure and that the modified surgical technique including traction sutures can further improve the success rate.
PMCID: PMC4306160  PMID: 25632189
Zenker diverticulum; Dysphagia; Aspiration pneumonia; Cricopharyngeal myotomy; Diverticulectomy; Transoral stapling; Flexible endoscopy; Short-form health survey questionnaire
13.  Minimally invasive surgical procedures for the treatment of lumbar disc herniation 
In up to 30% of patients undergoing lumbar disc surgery for herniated or protruded discs outcomes are judged unfavourable. Over the last decades this problem has stimulated the development of a number of minimally-invasive operative procedures. The aim is to relieve pressure from compromised nerve roots by mechanically removing, dissolving or evaporating disc material while leaving bony structures and surrounding tissues as intact as possible. In Germany, there is hardly any utilisation data for these new procedures – data files from the statutory health insurances demonstrate that about 5% of all lumbar disc surgeries are performed using minimally-invasive techniques. Their real proportion is thought to be much higher because many procedures are offered by private hospitals and surgeries and are paid by private health insurers or patients themselves. So far no comprehensive assessment comparing efficacy, safety, effectiveness and cost-effectiveness of minimally-invasive lumbar disc surgery to standard procedures (microdiscectomy, open discectomy) which could serve as a basis for coverage decisions, has been published in Germany.
Against this background the aim of the following assessment is:
Based on published scientific literature assess safety, efficacy and effectiveness of minimally-invasive lumbar disc surgery compared to standard procedures. To identify and critically appraise studies comparing costs and cost-effectiveness of minimally-invasive procedures to that of standard procedures. If necessary identify research and evaluation needs and point out regulative needs within the German health care system. The assessment focusses on procedures that are used in elective lumbar disc surgery as alternative treatment options to microdiscectomy or open discectomy. Chemonucleolysis, percutaneous manual discectomy, automated percutaneous lumbar discectomy, laserdiscectomy and endoscopic procedures accessing the disc by a posterolateral or posterior approach are included.
In order to assess safety, efficacy and effectiveness of minimally-invasive procedures as well as their economic implications systematic reviews of the literature are performed. A comprehensive search strategy is composed to search 23 electronic databases, among them MEDLINE, EMBASE and the Cochrane Library. Methodological quality of systematic reviews, HTA reports and primary research is assessed using checklists of the German Scientific Working Group for Health Technology Assessment. Quality and transparency of cost analyses are documented using the quality and transparency catalogues of the working group. Study results are summarised in a qualitative manner. Due to the limited number and the low methodological quality of the studies it is not possible to conduct metaanalyses. In addition to the results of controlled trials results of recent case series are introduced and discussed.
The evidence-base to assess safety, efficacy and effectiveness of minimally-invasive lumbar disc surgery procedures is rather limited:
Percutaneous manual discectomy: Six case series (four after 1998)Automated percutaneous lumbar discectomy: Two RCT (one discontinued), twelve case series (one after 1998)Chemonucleolysis: Five RCT, five non-randomised controlled trials, eleven case seriesPercutaneous laserdiscectomy: One non-randomised controlled trial, 13 case series (eight after 1998)Endoscopic procedures: Three RCT, 21 case series (17 after 1998)
There are two economic analyses each retrieved for chemonucleolysis and automated percutaneous discectomy as well as one cost-minimisation analysis comparing costs of an endoscopic procedure to costs for open discectomy.
Among all minimally-invasive procedures chemonucleolysis is the only of which efficacy may be judged on the basis of results from high quality randomised controlled trials (RCT). Study results suggest that the procedure maybe (cost)effectively used as an intermediate therapeutical option between conservative and operative management of small lumbar disc herniations or protrusions causing sciatica. Two RCT comparing transforaminal endoscopic procedures with microdiscectomy in patients with sciatica and small non-sequestered disc herniations show comparable short and medium term overall success rates. Concerning speed of recovery and return to work a trend towards more favourable results for the endoscopic procedures is noted. It is doubtful though, whether these results from the eleven and five years old studies are still valid for the more advanced procedures used today. The only RCT comparing the results of automated percutaneous lumbar discectomy to those of microdiscectomy showed clearly superior results of microdiscectomy. Furthermore, success rates of automated percutaneous lumbar discectomy reported in the RCT (29%) differ extremely from success rates reported in case series (between 56% and 92%).
The literature search retrieves no controlled trials to assess efficacy and/or effectiveness of laser-discectomy, percutaneous manual discectomy or endoscopic procedures using a posterior approach in comparison to the standard procedures. Results from recent case series permit no assessment of efficacy, especially not in comparison to standard procedures. Due to highly selected patients, modi-fications of operative procedures, highly specialised surgical units and poorly standardised outcome assessment results of case series are highly variable, their generalisability is low.
The results of the five economical analyses are, due to conceptual and methodological problems, of no value for decision-making in the context of the German health care system.
Aside from low methodological study quality three conceptual problems complicate the interpretation of results.
Continuous further development of technologies leads to a diversity of procedures in use which prohibits generalisation of study results. However, diversity is noted not only for minimally-invasive procedures but also for the standard techniques against which the new developments are to be compared. The second problem refers to the heterogeneity of study populations. For most studies one common inclusion criterion was "persisting sciatica after a course of conservative treatment of variable duration". Differences among study populations are noted concerning results of imaging studies. Even within every group of minimally-invasive procedure, studies define their own in- and exclusion criteria which differ concerning degree of dislocation and sequestration of disc material. There is the non-standardised assessment of outcomes which are performed postoperatively after variable periods of time. Most studies report results in a dichotomous way as success or failure while the classification of a result is performed using a variety of different assessment instruments or procedures. Very often the global subjective judgement of results by patients or surgeons is reported. There are no scientific discussions whether these judgements are generalisable or comparable, especially among studies that are conducted under differing socio-cultural conditions. Taking into account the weak evidence-base for efficacy and effectiveness of minimally-invasive procedures it is not surprising that so far there are no dependable economic analyses.
Conclusions that can be drawn from the results of the present assessment refer in detail to the specified minimally-invasive procedures of lumbar disc surgery but they may also be considered exemplary for other fields where optimisation of results is attempted by technological development and widening of indications (e.g. total hip replacement).
Compared to standard technologies (open discectomy, microdiscectomy) and with the exception of chemonucleolysis, the developmental status of all other minimally-invasive procedures assessed must be termed experimental. To date there is no dependable evidence-base to recommend their use in routine clinical practice. To create such a dependable evidence-base further research in two directions is needed: a) The studies need to include adequate patient populations, use realistic controls (e.g. standard operative procedures or continued conservative care) and use standardised measurements of meaningful outcomes after adequate periods of time. b) Studies that are able to report effectiveness of the procedures under everyday practice conditions and furthermore have the potential to detect rare adverse effects are needed. In Sweden this type of data is yielded by national quality registries. On the one hand their data are used for quality improvement measures and on the other hand they allow comprehensive scientific evaluations. Since the year of 2000 a continuous rise in utilisation of minimally-invasive lumbar disc surgery is observed among statutory health insurers. Examples from other areas of innovative surgical technologies (e.g. robot assisted total hip replacement) indicate that the rise will probably continue - especially because there are no legal barriers to hinder introduction of innovative treatments into routine hospital care. Upon request by payers or providers the "Gemeinsamer Bundesausschuss" may assess a treatments benefit, its necessity and cost-effectiveness as a prerequisite for coverage by the statutory health insurance. In the case of minimally-invasive disc surgery it would be advisable to examine the legal framework for covering procedures only if they are provided under evaluation conditions. While in Germany coverage under evaluation conditions is established practice in ambulatory health care only (“Modellvorhaben") examples from other European countries (Great Britain, Switzerland) demonstrate that it is also feasible for hospital based interventions. In order to assure patient protection and at the same time not hinder the further development of new and promising technologies provision under evaluation conditions could also be realised in the private health care market - although in this sector coverage is not by law linked to benefit, necessity and cost-effectiveness of an intervention.
PMCID: PMC3011322  PMID: 21289928
14.  Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718) 
BMC Surgery  2014;14:18.
Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal wall, which can lead to chronic pain. We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair.
The TISTA trial is a prospective, randomized, controlled, single-center trial with a two-by-two parallel design. All patients and outcome-assessors will be blinded to treatment allocations. For eligibility, patients must be male, ≥18 years old, and scheduled for laparoscopic repair of a primary inguinal hernia. One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples. The second group comprises patients with bilateral inguinal hernias. They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side. The primary endpoint will be pain under physical stress, measured at 24 h after surgery. Pain will be rated by the patient based on a numeric rating scale from 0 to 10, where 10 equals the worst pain imaginable. A total of 82 patients will be recruited (58 patients with unilateral inguinal hernias and 24 patients with bilateral hernias). This number is estimated to provide 90% power for detecting a pain reduction of one point on a numeric rating scale, with a standard deviation of one.
Patients with bilateral hernias will receive two meshes, one fixed with glue, and the other fixed with staples. This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients.
Trial registration NCT01641718
PMCID: PMC3994239  PMID: 24690207
Hernia repair; Fibrin glue; Staples; Mesh; Laparoscopy; Postoperative pain
15.  Long-term follow-up of endoscopic stapled diverticulotomy. 
We report a consecutive series of 31 patients who underwent endoscopic stapled diverticulotomy. The patients' notes were reviewed retrospectively to gather data on their original admission and a postal survey was conducted to establish patient satisfaction, their ability to swallow and re-operation data. Three patients were lost to follow-up. Nine of the remaining 28 died at a median of 18 months. The remaining 21 were followed up for a median of 59 months. The data showed that, at 5 years, 94.4% of patients had an improvement in their swallowing, and 50% had an entirely normal swallow. In order to achieve this result, 19% of patients required a second procedure, and one patient (3.2%) required a third (open) procedure. Endoscopic stapled diverticulotomy has well-established, short-term advantages. This series shows that it has a good long-term outcome that is similar to established open techniques and probably better than other techniques of endoscopic diverticulotomy, i.e. diathermy or laser.
PMCID: PMC2503805  PMID: 11995771
16.  Current status of minimally invasive endoscopic management for Zenker diverticulum 
Surgical resection has been the mainstay of treatment of pharyngoesophageal (Zenker) diverticula over the past century. Developments in minimally invasive surgery and new endoscopic devices have led to a paradigm change. The concept of dividing the septum between the esophagus and the pouch rather than resecting the pouch itself has been revisited during the last three decades and new technologies have been investigated to make the transoral operation safe and effective. The internal pharyngoesophageal myotomy accomplished through the transoral stapling approach has been shown to effectively relieve outflow obstruction and restore physiological bolus transit in patients with medium size diverticula. Transoral techniques, either through a rigid device or by flexible endoscopy, are gaining popularity over the open surgical approach due the low morbidity, the fast recovery time and the fact that the procedure can be safely repeated. We provide an analysis of the the current status of minimally invasive endoscopic management of Zenker diverticulum.
PMCID: PMC4325313
Zenker diverticulum; Endoscopic stapling; Cricopharyngeal myotomy; Diverticulectomy; Interventional flexible endoscopy
17.  Relationship between posterior pharyngeal pouch and hiatus hernia 
Thorax  1970;25(6):725-731.
The formation of posterior pharyngeal pouches is generally attributed to dysfunction of the cricopharyngeal sphincter. The reason for this dysfunction and its exact nature have not been established. Observations in the Royal Victoria Hospital, Belfast, suggested that an association exists between pharyngeal pouch and hiatus hernia. Barium studies performed in patients with a pharyngeal pouch using a described technique demonstrated the presence of a hiatus hernia in 32 out of 34 patients.
Illustrative case histories and a review of published work on cricopharyngeal function are provided to support our conclusions that gastro-oesophageal reflux is the primary factor leading to cricopharyngeal dysfunction, with the formation of a pharyngeal pouch in some cases. Several possible criticisms of this theory are discussed and the need for further investigation in patients with a pharyngeal pouch is emphasized. The management of patients with a pharyngeal pouch and hiatus hernia is briefly outlined.
PMCID: PMC472216  PMID: 5494681
18.  Surgical management of ulcerative colitis: a comparison of Canadian and American colorectal surgeons 
Canadian Journal of Surgery  2011;54(4):257-262.
Ileal pouch anal anastomosis (IPAA) to surgically manage ulcerative colitis may involve multiple separate surgical procedures, impacting treatment costs, length of stay in hospital, complication rates and patient outcomes, and there is currently no accepted standard of care regarding the number of stages that should be performed. The purpose of this study was to compare the practice patterns of Canadian and American colorectal surgeons regarding the surgical management of ulcerative colitis.
A questionnaire was mailed to all practisng fellows of the American Society of Colon and Rectal Surgeons (ASCRS) in Canada and the United States. Surgeons were asked to describe their typical practices for 3 clinical scenarios.
Questionnaires were mailed to 40 Canadian and 873 American ASCRS fellows with response rates of 86% and 62%, respectively. In the case of a patient who has had a prior colectomy, who is not taking steroids and in whom a tension-free IPAA is possible, 44% of Canadian surgeons would perform IPAA alone and 56% would perform IPAA with a loop ileostomy. In contrast, only 26% of American surgeons would perform IPAA alone and 74% would perform IPAA with a loop ileostomy (p = 0.002). In the case of a patient who has not had previous surgery, who is taking 10 mg/day of prednisone and in whom a tension-free IPAA is possible, the majority of both Canadian and American surgeons would perform an IPAA with a loop ileostomy (93% and 89%, respectively, p = 0.06). In the case of a patient who has not had previous surgery, who is taking 40 mg/day of prednisone and in whom a tension-free IPAA is possible, 45% of Canadian surgeons would perform a subtotal colectomy with an end ileostomy compared with 14% of American surgeons (p < 0.001).
There are significant differences in the surgical management of ulcerative colitis between Canadian and American colorectal surgeons.
PMCID: PMC3191900  PMID: 21651831
19.  In vitro description of a new technique for stapled side-to-side jejunocecal anastomosis in horses and CT scan anatomical comparison with other techniques 
BMC Veterinary Research  2014;10(Suppl 1):S9.
Stapled jejunocecal anastomoses are commonly performed in equine abdominal surgery. They carry higher complication rates compared to handsewn techniques. In human surgery various causes likely to lead to failure of stapled techniques have been evaluated, including staple line failure. Recently Freeman proposed a technique to perform a stapled jejunocecal anastomosis in horses while avoiding blind pouch formation. The aim of this study is to describe a method for stapled side-to-side jejunocecal anastomosis in horses and to compare it with other techniques with computed tomography to assess stomal area, shape and blind pouch size.
Intestinal specimens comprising the cecum, ileum and jejunum from 18 horses were collected and were divided into three groups. In Group S a standard stapled side-to-side jejunocecal anastomosis was performed. In Group F the anastomosis was performed using a modified technique proposed by Freeman. In Group G the anastomosis was performed with a modified technique proposed by the authors. Inflated bowel segments were CT scanned to obtain a MultiPlanar Reconstruction of the stoma and afferent small intestine before calculating the cross-sectional area of each of these regions. The ratio of the measured areas was compared between the three techniques. The volume of the blind-end pouch was measured and its ratio with the intestinal area compared between techniques. The cecum was opened and the length of the stoma measured with a caliper and compared to the intended initial length.
The stomal/intestinal area ratio was not significantly different between techniques.
No statistically significant difference was found in the stomal ideal/real perimeter ratio.
There was no statistically significant difference in the intended/real stomal length ratio, and all techniques featured an increase in stomal length ranging from 2 to 12 %. Blind pouch formation was a consistent finding in Group S and was virtually absent in Groups F and G.
Both the Freeman and the new (G) technique were comparable to the standard technique in terms of stomal area, stomal shape and difference in stomal elongation. They consistently produced a smaller blind pouch and allowed easier placement of the staplers.
PMCID: PMC4122904  PMID: 25238113
20.  The current practice trends in pediatric bone-anchored hearing aids in Canada: a national clinical and surgical practice survey 
Since the introduction of bone-anchored hearing aids (BAHAs) in the 1980s, the practices of surgeons who implant these hearing aids have become varied; different indications and surgical techniques are utilized depending on the surgeon and institution. The objective of the current study is to describe the clinical and surgical practices of otolaryngologists in Canada who perform pediatric BAHA operations.
A detailed practice questionnaire was devised and sent to all members of the Canadian Society of Otolaryngology-Head and Neck Surgery. Those who performed pediatric BAHA surgeries were asked to participate.
Twelve responses were received (response rate of 80%). All of the respondents identified congenital aural atresia to be an indication for pediatric BAHAs. Other indications were chronic otitis externa or media with hearing loss (92%), allergic reactions to conventional hearing aids (75%), congenital fixation or anomaly of ossicular chain (67%), and unilateral deafness (25%). Minor complications, such as skin reactions, were reported in 25% of cases, while major complications were very rare. There was great variability with regards to surgical techinque and post-operative management. The extent of financial support for the BAHA hardware and device also varied between provinces, and even within the same province.
There is a lack of general consensus regarding pediatric BAHA surgeries in Canada. With such a small community of otolaryngologists performing this procedure, we are hopeful that this survey can serve as an impetus for a national collaboration to establish a set of general management principles and inspire multi-site research ventures.
PMCID: PMC3702399  PMID: 23815797
Bone-anchored hearing aid; BAHA; Surgical practice; Clinical practice; Practice survey; Pediatrics
21.  Clinical experience with a multifunctional, flexible surgery system for endolumenal, single-port, and NOTES procedures 
Surgical Endoscopy  2010;25(2):586-592.
Single-port and incisionless surgical approaches hold the promise of fewer complications, reduced pain, faster recovery, and improved cosmesis compared with traditional open or laparoscopic approaches. The ability to select an access approach (i.e., endolumenal, single-port, transvaginal, or transgastric) with one platform may be important to optimization of individual patient results. The authors report their results using these four separate surgical approaches tailored to three different therapeutic procedures, all with the use of a single flexible platform, the Incisionless Operating Platform (IOP).
After institutional review board approval, the IOP was used to perform nine cholecystectomies via transvaginal (TV) (n = 4), transgastric (TG) (n = 4), and single-port transumbilical (TU) (n = 1) access. Two appendectomies were performed via TG access. Endolumenal access was used for 18 gastric pouch and stoma reductions after Roux-en-Y gastric bypass. The TG and TV procedures involved the use of one to three trocars. The recorded data included safety, procedural success, operative time, patient pain assessment (on a 0–10 scale) at discharge, and length of hospital stay.
Procedural success was achieved for 16 of 18 endolumenal procedures, 1 of 1 single-port procedure, and 10 of 10 NOTES procedures. For 5 of 10 NOTES procedures, only one small trocar was required. The mean operative times were 79 min for pouch with stoma reduction, 171 min for cholecystectomy, and 274 min for appendectomy. Of 29 patients, 27 were discharged in 24 h or less. The average pain scores were 0.44 for pouch with stoma reduction, 1.3 for cholecystectomy, and 2.5 for appendectomy. No significant complications occurred. The ergonomics of IOP allowed the surgeon to interface with the system using an endoscopic or laparoscopic orientation.
Availability of a multifunctional, flexible surgery platform provides a choice of a single-port or incisionless surgical approach with the potential to reduce complications, pain, and recovery time while improving cosmesis.
PMCID: PMC3032221  PMID: 20734085
Endolumenal surgery; Incisionless surgery; NOTES instrumentation; NOTES surgery; Single-port-access surgery
22.  Bell's palsy 
Clinical Evidence  2011;2011:1204.
Bell's palsy is characterised by an acute, unilateral, partial, or complete paralysis of the face (i.e., lower motor neurone pattern). The weakness may be partial (paresis) or complete (paralysis), and may be associated with mild pain, numbness, increased sensitivity to sound, and altered taste. Bell's palsy remains idiopathic, but a proportion of cases may be caused by reactivation of herpes viruses from the geniculate ganglion of the facial nerve. Bell's palsy is most common in people aged 15 to 40 years, with a 1 in 60 lifetime risk. Most make a spontaneous recovery within 1 month, but up to 30% show delayed or incomplete recovery.
Methods and outcomes
We conducted a systematic review to answer the following clinical question: What are the effects of treatments in adults and children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antiviral treatment, corticosteroids (alone or plus antiviral treatment), hyperbaric oxygen therapy, facial nerve decompression surgery, and facial retraining.
Key Points
Bell's palsy is an idiopathic, unilateral, acute paresis or paralysis of facial movement caused by dysfunction of the lower motor neurone. Up to 30% of people with acute peripheral facial palsy have an alternative cause diagnosed at presentation or during the course of their facial palsy. Alternative causes are higher in children (>50%), warranting specialist evaluation at presentation. Severe pain, vesicles (ear or oral), and hearing loss or imbalance, suggest Ramsay Hunt syndrome caused by herpes zoster virus infection, which requires specialist management. Most people with paresis (partial weakness) make a spontaneous recovery within 3 weeks. Up to 30% of people, typically people with paralysis (complete palsy), have a delayed or incomplete recovery.
Corticosteroids alone improve rate of recovery and the proportion of people who make a full recovery, and reduce cosmetically disabling sequelae, motor synkinesis, and autonomic dysfunction compared with placebo or no treatment.
Antiviral treatment alone is no more effective than placebo and is less effective than corticosteroid treatment at improving recovery of facial motor function and at reducing the risk of disabling sequelae.
For people with paresis at presentation (about 70%), there is no evidence of a clinically important additive effect of adding antivirals to corticosteroid therapy. For people who develop paralysis (about 30%), and may demonstrate a trend towards complete degeneration on electrophysiological testing, it is unknown whether adding antiviral treatment to corticosteroid therapy has a significant additive or synergistic effect.
Hyperbaric oxygen may improve time to recovery and the proportion of people who make a full recovery compared with corticosteroids; however, the evidence for this is weak.
We don't know whether facial nerve decompression surgery is beneficial in Bell's palsy.
Facial retraining may improve recovery of facial motor function scores including stiffness and lip mobility, and may reduce the risk of motor synkinesis in Bell's palsy, but the evidence is too weak to draw conclusions.
Clinical guide Good evidence exists that corticosteroid therapy improves facial palsy in people with Bell's palsy independent of severity at presentation. Treatment is likely to be more effective when started within 72 hours of onset, and less effective after 7 days. Contraindications to corticosteroid therapy exist and adverse effects are more likely following 7 days of treatment. Combination therapy with a corticosteroid and antiviral is no more effective than corticosteroid therapy alone for Bell's palsy; however, combination therapy should be considered when there is evidence of viral infection with herpes zoster, such as zoster sine herpete and Ramsay Hunt syndrome. People presenting with complete facial paralysis should be offered a choice of combination therapy with a corticosteroid and antiviral, because the evidence for therapy without antivirals is not yet definitive for this group and antivirals have few adverse effects. In people presenting with mild facial paresis from Bell's palsy, there is a high rate of spontaneous resolution without treatment. Bell's palsy is a diagnosis of exclusion and clinicians should remain mindful of the causes of facial palsy, including tumour and infection. All children presenting with facial palsy and adults with delayed recovery should be referred for assessment by an otolaryngologist - head and neck surgeon or other appropriate specialist. The authors believe that facial palsy should not be treated only by protocol-driven practice. Bell's palsy is a diagnosis of exclusion, although a search for other causes of facial palsy must not delay treatment of likely Bell's palsy. Patients should have the opportunity to participate in an informed choice in their management where relevant.
PMCID: PMC3275144  PMID: 21375786
23.  Ileal pouch anal anastomosis with modified double-stapled mucosectomy-the experience in China 
AIM: To investigate the feasibility and long-term functional outcome of ileal pouch-anal anastomosis with modified double-stapled mucosectomy.
METHODS: From January 2002 to March 2011, fourty-five patients underwent ileal pouch anal anastomosis with modified double-stapled mucosectomy technique and the clinical data obtained for these patients were reviewed.
RESULTS: Patients with ulcerative colitis (n = 29) and familial adenomatous polyposis (n = 16) underwent ileal pouch-anal anastomosis with modified double-stapled mucosectomy. Twenty-eight patients underwent one-stage restorative proctocolectomy, ileal pouch anal anastomosis, protective ileostomy and the ileostomy was closed 4-12 mo postoperatively. Two-stage procedures were performed in seventeen urgent patients, proctectomy and ileal pouch anal anastomosis were completed after previous colectomy with ileostomy. Morbidity within the first 30 d of surgery occurred in 10 (22.2%) patients, all of them could be treated conservatively. During the median follow-up of 65 mo, mild to moderate anastomotic narrowing was occurred in 4 patients, one patient developed persistent anastomotic stricture and need surgical intervention. Thirty-five percent of patients developed at least 1 episode of pouchitis. There was no incontinence in our patients, the median functional Oresland score was 6, 3 and 2 after 1 year, 2.5 years and 5 years respectively. Nearly half patients (44.4%) reported “moderate functioning”, 37.7% reported “good functioning”, whereas in 17.7% of patients “poor functioning” was observed after 1 year. Five years later, 79.2% of patients with good function, 16.7% with moderate function, only 4.2% of patients with poor function.
CONCLUSION: The results of ileal pouch anal anastomosis with modified double-stapled mucosectomy technique are promising, with a low complication rate and good long-term functional results.
PMCID: PMC3587488  PMID: 23483639
Ileal pouch anal anastomosis; Stapled mucosectomy; Ulcerative colitis; Familial adenomatous polyposis; Surgical technique
24.  Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial 
A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material.
A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery.
Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds.
Trial Registration
This trial was registered at under the identifier NCT01146236 (registered June 14, 2010)
PMCID: PMC3495200  PMID: 22672186
Wound closure; Orthopaedic surgery; Sutures; Staples; Surgical wound complications; Surgical site infection
25.  Endoscopic treatment of Zenker’s diverticulum by carbon dioxide laser 
The management of Zenker’s diverticulum remains controversial, as both external and endoscopic procedures are potentially associated with post-operative complications and risks. The endoscopic approach is based on cricopharyngeal myotomy or myectomy by laser, cautery or stapling. A retrospective chart review has been made from December 1994 to April 2009 of all patients with Zenker’s diverticulum treated by endoscopic cricopharyngeal myectomy using CO2 laser at the Department of Otorhinolaryngology – Head and Neck Surgery of the University of Brescia, Italy. Of the 28 patients (19 males, 9 females; mean age, 64 years; range, 46-95) scheduled for the trans-oral procedure, 27 (96%) were endoscopically treated. Diagnosis was based on the patient’s history, flexible fiberoptic examination of the larynx, hypopharynx, and oesophagus, and videofluoroscopy with barium. Exclusion criteria included severe medical co-morbidities, impossibility to endoscopically expose the diverticulum, and small (< 2 cm) or large (> 6 cm) diverticula. The endoscopic procedure was performed using a CO2 laser to section the cricopharyngeal muscle and remove the posterior part in order to obtain partial myectomy. Major complications occurred in 2 (7%) patients. No cases of recurrent nerve paralysis, pharyngo-cutaneous fistula, neck emphysema, post-operative bleeding, mediastinitis or aspiration pneumonia were observed in the present series. A swallow survey was obtained by telephone: 85% of patients reported improved swallowing (without symptoms in 11 and with moderate dysphagia in 7). Based on the present series, endoscopic CO2 laser cricopharyngeal myectomy for Zenker’s diverticulum can be considered an effective and safe procedure, with reduced hospitalization time and complication rate.
PMCID: PMC2881603  PMID: 20559466
Zenker’s diverticulum; Endoscopic treatment; Carbon dioxide laser; Cricopharyngeal myectomy

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