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1.  Dacron® vs. PTFE as bypass materials in peripheral vascular surgery – systematic review and meta-analysis 
BMC Surgery  2008;8:22.
Background
In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. It is unclear which of the two commonly used materials, polytetrafluoroethylene (PTFE) or polyester (Dacron®) grafts, is to be preferred. Thus, the aim of this meta-analysis and systematic review was to compare the effectiveness of these two prosthetic bypass materials (Dacron® and PTFE).
Methods
We performed a systematic literature search in MEDLINE, Cochrane-Library – CENTRAL, EMBASE and other databases for relevant publications in English and German published between 1999 and 2008. Only randomized controlled trials were considered for inclusion. We assessed the methodological quality by means of standardized checklists. Primary patency was used as the main endpoint. Random-effect meta-analysis as well as pooling data in life table format was performed to combine study results.
Results
Nine randomized controlled trials (RCT) were included. Two trials showed statistically significant differences in primary patency, one favouring Dacron® and one favouring PTFE grafts, while 7 trials did not show statistically significant differences between the two materials. Meta-analysis on the comparison of PTFE vs. Dacron® grafts yielded no differences with regard to primary patency rates (hazard ratio 1.04 (95% confidence interval [0.85;1.28]), no significant heterogeneity (p = 0.32, I2 = 14%)). Similarly, there were no significant differences with regard to secondary patency rates.
Conclusion
Systematic evaluation and meta-analysis of randomized controlled trials comparing Dacron® and PTFE as bypass materials for peripheral vascular surgery showed no evidence of an advantage of one synthetic material over the other.
doi:10.1186/1471-2482-8-22
PMCID: PMC2645354  PMID: 19099583
2.  Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus (CROSS) 
BMC Surgery  2008;8:21.
Background
A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases (cT1-3 N0-1 M0). A high percentage of irradical resections is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone and in trials in which patients are treated with surgery alone. Improvement of locoregional control by using neoadjuvant chemoradiotherapy might therefore improve the prognosis in these patients. We previously reported that after neoadjuvant chemoradiotherapy with weekly administrations of Carboplatin and Paclitaxel combined with concurrent radiotherapy nearly always a complete R0-resection could be performed. The concept that this neoadjuvant chemoradiotherapy regimen improves overall survival has, however, to be proven in a randomized phase III trial.
Methods/design
The CROSS trial is a multicenter, randomized phase III, clinical trial. The study compares neoadjuvant chemoradiotherapy followed by surgery with surgery alone in patients with potentially curable esophageal cancer, with inclusion of 175 patients per arm.
The objectives of the CROSS trial are to compare median survival rates and quality of life (before, during and after treatment), pathological responses, progression free survival, the number of R0 resections, treatment toxicity and costs between patients treated with neoadjuvant chemoradiotherapy followed by surgery with surgery alone for surgically resectable esophageal adenocarcinoma or squamous cell carcinoma. Over a 5 week period concurrent chemoradiotherapy will be applied on an outpatient basis. Paclitaxel (50 mg/m2) and Carboplatin (Area-Under-Curve = 2) are administered by i.v. infusion on days 1, 8, 15, 22, and 29. External beam radiation with a total dose of 41.4 Gy is given in 23 fractions of 1.8 Gy, 5 fractions a week. After completion of the protocol, patients will be followed up every 3 months for the first year, every 6 months for the second year, and then at the end of each year until 5 years after treatment. Quality of life questionnaires will be filled out during the first year of follow-up.
Discussion
This study will contribute to the evidence on any benefits of neoadjuvant treatment in esophageal cancer patients using a promising chemoradiotherapy regimen.
Trial registration
ISRCTN80832026
doi:10.1186/1471-2482-8-21
PMCID: PMC2605735  PMID: 19036143
3.  What happens to the external carotid artery following carotid endarterectomy? 
BMC Surgery  2008;8:20.
Aims
The effect of carotid endarterectomy on the patency of the external carotid artery is unknown. We conducted a retrospective study to evaluate the long-term changes in the external carotid artery following carotid endarterectomy.
Methods
Data was prospectively recorded for all patients who had carotid endarterectomy between 1997 and 2006 in our vascular surgical unit. These patients had follow-up with carotid duplex ultrasound to assess the patency of the internal and external carotid artery. The data were retrieved and evaluated for patency and flow characteristic in both arteries before and after surgery.
Results
Carotid endarterectomy was performed on 255 occasions in 236 patients over the ten year study period. Immediate and long-term outcome of carotid endarterectomy is comparable to results at other major centers. Stenosis of the external carotid artery as detected by duplex scan occurred in 5.5% of patients and was totally asymptomatic.
Conclusion
Our results of carotid endarterectomy are comparable to other centers. Long-term follow up of the external carotid artery with duplex scan showed asymptomatic stenosis in a small percentage of patients.
doi:10.1186/1471-2482-8-20
PMCID: PMC2596080  PMID: 19025671
4.  Aortic replacement in aorto-occlusive disease: an observational study 
BMC Surgery  2008;8:19.
Background
For many patients with aorto-occlusive disease, where stent deployment is not possible, surgery remains the only treatment option available. The aim of this study was to assess the results of aortic reconstruction surgery performed in patients with critical ischaemia.
Methods
All patients with critical ischaemia undergoing surgery during 1991–2004 were identified from a prospectively maintained database. Mortality data was verified against death certificate data. Demographic and clinical data were obtained from the clinical notes and the radiology database. Disease was classified as: type I – limited to aorta and common iliac arteries; type II – external iliac disease and type III combined aortic, iliac and infra-inguinal disease.
Results
86 patients underwent aortic replacement surgery all of whom had critical ischaemia consisting of: type I (n = 16); type II (n = 37) and type III (n = 33). The 30-day mortality rate was 10.4%, the one-year patient survival was 80%, and the 1-year graft survival was 80%. At 2 years the actual patient survival was 73% and no additional graft losses were identified. All patients surviving 30 days reported excellent symptomatic relief. Early, complications occurred in 6 (7%) patients: thrombosis within diseased superficial femoral arteries (n = 4); haemorrhage and subsequent death (n = 2). Ten (14%) late complications (> 12 months) occurred in the 69 surviving patients and included: anastomotic stenosis (n = 3); graft thrombosis (n = 4), graft infection (n = 3). Four patients developed claudication as a result of more distal disease in the presence of a patent graft, and 1 patient who continued smoking required an amputation for progressive distal disease.
Conclusion
Aortic reconstruction for patients with extensive aorto-occlussive disease provides long-standing symptomatic relief for the majority of patients. After the first year, there is continued patient attrition due to co-existent cardiovascular disease but no further graft losses.
doi:10.1186/1471-2482-8-19
PMCID: PMC2588438  PMID: 18976456
5.  Clinical evaluation of an air-capsule technique for the direct measurement of intra-abdominal pressure after elective abdominal surgery 
BMC Surgery  2008;8:18.
Background
The gold standard for assessment of intraabdominal pressure (IAP) is via intravesicular pressure measurement (IVP). This accepted technique has some inherent problems, e.g. indirectness. Aim of this clinical study was to assess direct IAP measurement using an air-capsule method (ACM) regarding complications risks and agreement with IVP in patients undergoing abdominal surgery.
Methods
A prospective cohort study was performed in 30 patients undergoing elective colonic, hepatic, pancreatic and esophageal resection. For ACM a Probe 3 (Spiegelberg®, Germany) was placed on the greater omentum. It was passed through the abdominal wall paralleling routine drainages. To compare ACM with IVP t-testing was performed and mean difference as well as limits of agreement were calculated.
Results
ACM did not lead to complications particularly with regard to organ lesion or surgical site infection. Mean insertion time of ACM was 4.4 days (min-max: 1–5 days). 168 pairwise measurements were made. Mean ACM value was 7.9 ± 2.7 mmHg while mean IVP was 8.4 ± 3.0 mmHg (n.s). Mean difference was 0.4 mmHg ± 2.2 mmHg. Limits of agreement were -4.1 mmHg to 5.1 mmHg.
Conclusion
Using ACM, direct IAP measurement is feasible and uncomplicated. Associated with relatively low pressure ranges (<17 mmHg), results are comparable to bladder pressure measurement.
doi:10.1186/1471-2482-8-18
PMCID: PMC2575193  PMID: 18925973
6.  Could lymphatic mapping and sentinel node biopsy provide oncological providence for local resectional techniques for colon cancer? A review of the literature 
BMC Surgery  2008;8:17.
Background
Endoscopic resectional techniques for colon cancer are undermined by their inability to determine lymph node status. This limits their application to only those lesions at the most minimal risk of lymphatic dissemination whereas their technical capacity could allow intraluminal or even transluminal address of larger lesions. Sentinel node biopsy may theoretically address this breach although the variability of its reported results for this disease is worrisome.
Methods
Medline, EMBASE and Cochrane databases were interrogated back to 1999 to identify all publications concerning lymphatic mapping for colon cancer with reference cross-checking for completeness. All reports were examined from the perspective of in vivo technique accuracy selectively in early stage disease (i.e. lesions potentially within the technical capacity of endoscopic resection).
Results
Fifty-two studies detailing the experiences of 3390 patients were identified. Considerable variation in patient characteristics as well as in surgical and histological quality assurances were however evident among the studies identified. In addition, considerable contamination of the studies by inclusion of rectal cancer without subgroup separation was frequent. Indeed such is the heterogeneity of the publications to date, formal meta-analysis to pool patient cohorts in order to definitively ascertain technique accuracy in those with T1 and/or T2 cancer is not possible. Although lymphatic mapping in early stage neoplasia alone has rarely been specifically studied, those studies that included examination of false negative rates identified high T3/4 patient proportions and larger tumor size as being important confounders. Under selected circumstances however the technique seems to perform sufficiently reliably to allow it prompt consideration of its use to tailor operative extent.
Conclusion
The specific question of whether sentinel node biopsy can augment the oncological propriety for endoscopic resective techniques (including Natural Orifice Transluminal Endoscopic Surgery [NOTES]) cannot be definitively answered at present. Study heterogeneity may account for the variability evident in the results from different centers. Enhanced capacity (perhaps to the level necessary to consider selective avoidance of en bloc mesenteric resection) by its confinement to only early stage disease is plausible although not proven. Specific study of the technique in early stage tumors is clearly essential before proffering this approach.
doi:10.1186/1471-2482-8-17
PMCID: PMC2565653  PMID: 18816403
7.  Robotic assisted Laparoscopic partial Nephrectomy for suspected Renal Cell Carcinoma: Retrospective review of surgical outcomes of 35 Cases 
BMC Surgery  2008;8:16.
Background
A standard of care for the treatment of small renal masses is partial nephrectomy. The open and laparoscopic approaches have been well described in the literature. Robotic assistance may augment partial nephrectomy by aiding in dissection and renal reconstruction. In this communication we describe the surgical outcomes of 35 patients undergoing robotic partial nephrectomy.
Methods
Patient records and databases were reviewed for 35 consecutive patients undergoing RPN. Clinical, pathological, and radiographic data were obtained. The data was deidentified.
Results
Thirty five patients successfully underwent RPN. An additional 2 patients were converted to other nephron sparing procedures. Mean tumor size was 2.8 cm, and mean OR time was 142 minutes. Mean warm ischemia time was 20 minutes. All margins were negative. There were 4 complications, and no patients required reoperation.
Conclusion
Robotic partial nephrectomy can produce excellent initial results. Further studies should be performed to compare the outcomes to laparoscopic and open operations.
doi:10.1186/1471-2482-8-16
PMCID: PMC2564900  PMID: 18816400
8.  Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial) 
BMC Surgery  2008;8:15.
Background
With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.
The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs.
Methods/design
The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007.
Discussion
The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease.
Trial registration
Nederlands Trial Register NTR1150
doi:10.1186/1471-2482-8-15
PMCID: PMC2533646  PMID: 18721465
9.  The One-stop trial: Does electronic referral and booking by the general practitioner (GPs) to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol 
BMC Surgery  2008;8:14.
Background
Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery.
Materials and Methods
In a randomised controlled trial, selected patients (inguinal hernia, gallstone disease and pilonidal sinus) referred to the university hospital are either randomised to direct electronic referral and booking for outpatient surgery (one stop), or to the traditional patient pathway where all patients are seen at the outpatient clinic several weeks ahead of surgery.
Consultants in gastrointestinal surgery designed standardised referral forms and guidelines. New software has been designed making it possible to implement referral forms, guidelines and patient information in the GP's electronic health record. For "one-stop" referral, GPs must provide mandatory information about the specific condition. Referrals were linked to a booking system, enabling the GPs to book the hospital, day and time for outpatient surgery. The primary endpoints are waiting time and costs. The sample size calculation was based on waiting time. A reduction in waiting time of 60 days (effect size), 25%, is significant, resulting in a sample size of 120 patients in total.
Discussion
Poor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it feasible to use a one-stop approach for all patients undergoing surgery on an outpatient basis for inguinal hernia, pilonidal sinus and gallstones.
In this study we wanted to investigate the waiting time and cost-effectiveness of direct electronic referral and booking of outpatient surgery compared to the traditional patient pathway, where the patient is seen at the outpatient clinic prior to surgery.
Trial registration
This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00692497
doi:10.1186/1471-2482-8-14
PMCID: PMC2527297  PMID: 18694477
10.  Interest of retro-anal levator plate myorrhaphy in selected cases of descending perineum syndrome with positive anti-sagging test 
BMC Surgery  2008;8:13.
Background
Levator plate sagging (LPS), usually called descending perineum syndrome, is one of the main defects encountered in perineology. This defect is classically associated with colo-proctologic functional troubles (dyschesia and anal incontinence) but can also induce perineodynia, gynaecological and lower urinary tract symptoms.
Methods
A retrospective case series of nine female patients (mean age: 44.3) underwent an isolated retro-anal levator plate myorrhaphy (RLPM) to treat symptomatic LPS confirmed by rectal examination and/or Perineocaliper®. An anti-sagging test (support of the posterior perineum) must significantly improve the symptoms that were resistant to conservative treatment. The effect of the procedure on the symptoms of the 3 axes of the perineum (urological, colo-proctologic and gynecological) and on perineodynia was evaluated during a follow up consultation more than 9 months after surgery. The effect of RLPM on the position of the anal margin and on the levator plate angle was studied using rectal examination, Perineocaliper® and retro-anal ultrasound.
Results
Before surgery, anti-sagging tests were positive for dyschesia, urinary urgency and pain. After a mean follow-up of 16.1 months, RLPM resolved or improved 2/2 cases of stress urinary incontinence, 3/5 of urinary urgency, 3/4 of dysuria, 3/3 of anal incontinence, 7/8 of dyschesia, 3/4 of cystocele, 4/5 of rectocele, 5/8 of dyspareunia and 6/7 of perineodynia. Rectal examination showed a complete suppression of sagging in 4 patients and an improvement in the 5 others. The mean reduction of perineal descent was 1.08 cm (extremes: 0–1.5). Using retro-anal ultrasound of the levator plate, the mean reduction of sagging was 12.67 degrees (extremes: 1 – 21).
Conclusion
Anti-sagging tests can be used before surgery to simulate the effect of RLPM. This surgical procedure seems to improve stress urinary incontinence, frequency, nocturia, urgency, dysuria, anal incontinence, dyschesia, dyspareunia, perineodynia, cystocele and rectocele. These results must be confirmed by a larger case series.
doi:10.1186/1471-2482-8-13
PMCID: PMC2533292  PMID: 18667056
11.  A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079] 
BMC Surgery  2008;8:12.
Background
Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency.
Design
This is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax® suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus® and PDS® will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 ± 1 months after surgery.
Conclusion
This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient.
Trial registration
NCT005725079
doi:10.1186/1471-2482-8-12
PMCID: PMC2492842  PMID: 18644124
12.  The Anal Fistula Plug versus the mucosal advancement flap for the treatment of Anorectal Fistula (PLUG trial) 
BMC Surgery  2008;8:11.
Background
Low transsphincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the anal fistula plug showed promising results.
The anal fistula plug trial is designed to compare the anal fistula plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain, and quality of life.
Methods/design
The PLUG trial is a randomized controlled multicenter trial. Sixty patients with high perianal fistulas of cryptoglandular origin will be randomized to either the fistula plug or the mucosal advancement flap. Study parameters will be anorectal fistula closure-rate, continence, post-operative pain, and quality of life. Patients will be followed-up at two weeks, four weeks, and 16 weeks. At the final follow-up closure rate is determined by clinical examination by a surgeon blinded for the intervention.
Discussion
Before broadly implementing the anal fistula plug results of randomized trials using the plug should be awaited. This randomized controlled trial comparing the anal fistula plug and the mucosal advancement flap should provide evidence regarding the effectiveness of the anal fistula plug in the treatment of high perianal fistulas.
Trial registration
ISRCTN: 97376902
doi:10.1186/1471-2482-8-11
PMCID: PMC2467399  PMID: 18573198
13.  Intravenous postoperative fluid prescriptions for children: A survey of practice 
BMC Surgery  2008;8:10.
Background
Postoperative deaths and neurological injury have resulted from hyponatraemia associated with the use of hypotonic saline solutions following surgery. We aimed to determine the rates and types of intravenous fluids being prescribed postoperatively for children in the UK.
Methods
A questionnaire was sent to members of the British Association of Paediatric Surgeons (BAPS) and Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI) based at UK paediatric centres. Respondents were asked to prescribe postoperative fluids for scenarios involving children of different ages. The study period was between May 2006 and November 2006.
Results
The most frequently used solution was sodium chloride 0.45% with glucose 5% although one quarter of respondents still used sodium chloride 0.18% with glucose 4%. Isotonic fluids were used by 41% of anaesthetists and 9.8% of surgeons for the older child, but fewer for infants. Standard maintenance rates or greater were prescribed by over 80% of respondents.
Conclusion
Most doctors said they would prescribe hypotonic fluids at volumes equal to or greater than traditional maintenance rates at the time of the survey. A survey to describe practice since publication of National Patient Safety Agency (NPSA) recommendations is required.
doi:10.1186/1471-2482-8-10
PMCID: PMC2435100  PMID: 18541019
14.  The efficacy of 'Radio guided Occult Lesion Localization' (ROLL) versus 'Wire-guided Localization' (WGL) in breast conserving surgery for non-palpable breast cancer: A randomized clinical trial – ROLL study 
BMC Surgery  2008;8:9.
Background
With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care.
The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome.
Methods/design
The ROLL trial is a multi center randomized clinical trial. Over a period of 2–3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure.
The rationale, study design and planned analyses are described.
Trial Registration
(, study protocol number NCT00539474)
doi:10.1186/1471-2482-8-9
PMCID: PMC2409294  PMID: 18495027
15.  Non-invasive monitoring of tissue oxygenation during laparoscopic donor nephrectomy 
BMC Surgery  2008;8:8.
Background
Standard methods for assessment of organ viability during surgery are typically limited to visual cues and tactile feedback in open surgery. However, during laparoscopic surgery, these processes are impaired. This is of particular relevance during laparoscopic renal donation, where the condition of the kidney must be optimized despite considerable manipulation. However, there is no in vivo methodology to monitor renal parenchymal oxygenation during laparoscopic surgery.
Methods
We have developed a method for the real time, in vivo, whole organ assessment of tissue oxygenation during laparoscopic nephrectomy to convey meaningful biological data to the surgeon during laparoscopic surgery. We apply the 3-CCD (charge coupled device) camera to monitor qualitatively renal parenchymal oxygenation with potential real-time video capability.
Results
We have validated this methodology in a porcine model across a range of hypoxic conditions, and have then applied the method during clinical laparoscopic donor nephrectomies during clinically relevant pneumoperitoneum. 3-CCD image enhancement produces mean region of interest (ROI) intensity values that can be directly correlated with blood oxygen saturation measurements (R2 > 0.96). The calculated mean ROI intensity values obtained at the beginning of the laparoscopic nephrectomy do not differ significantly from mean ROI intensity values calculated immediately before kidney removal (p > 0.05).
Conclusion
Here, using the 3-CCD camera, we qualitatively monitor tissue oxygenation. This means of assessing intraoperative tissue oxygenation may be a useful method to avoid unintended ischemic injury during laparoscopic surgery. Preliminary results indicate that no significant changes in renal oxygenation occur as a result of pneumoperitoneum.
doi:10.1186/1471-2482-8-8
PMCID: PMC2394515  PMID: 18419819
16.  Different tissue reaction of oesophagus and diaphragm after mesh hiatoplasty. Results of an animal study 
BMC Surgery  2008;8:7.
Background
Laparoscopic mesh-reinforcement of the hiatal region in the treatment of gastroesophageal reflux disease (GERD) and paraesophageal hernia (PEH) reduces the risk of recurrence. However, there are still controversies about the technique of mesh placement, shape, structure and material. We therefore compared tissue integration and scar formation after implantation of two different polypropylene-meshes in a rabbit model.
Methods
A total of 20 female chinchilla rabbits were included in this study. Two different meshes (Polypropylene PP, Polyglecaprone 25 Composite PP-PG) were implanted on the abdominal diaphragm around the oesophagus. After 3 months the implanted meshes were excised en-bloc. Histological and morphological analyses were carried out accordingly proliferation rate, apoptosis and collagen type I/III ratio.
Results
Regarding proliferation rate of oesophagus PP (9.31 ± 3.4%) and PP-PG (13.26 ± 2.54%) differ in a significant (p = 0.0097) way. In the diaphragm we found a significant (p = 0.00066) difference between PP (9.43 ± 1.45%) and PP-PG (18.73 ± 5.92%) respectively. Comparing oesophagus and diaphragm we could prove a significant difference within PP-PG-group (p = 0.0195). Within PP-group the difference reached no statistical significance (p = 0.88). We found analogous results regarding apoptosis.
Furthermore, there is a significant (p = 0.00013) difference of collagen type I/III ratio in PP-PG (12.28 ± 0.8) compared to PP (8.44 ± 1,63) in case of oesophageal tissue. Concerning diaphragm we found a significant difference (p = 0.000099) between PP-PG (8.85 ± 0.81) and PP (6.32 ± 1.07) as well.
Conclusion
The histologic and morphologic characteristics after prosthetic enforcement of the hiatus in this animal model show a more distinct tissue integration using PP-PG compared to PP. Additionally, different wound healing and remodelling capability influence tissue integration of the mesh in diaphragm and oesophagus.
doi:10.1186/1471-2482-8-7
PMCID: PMC2330020  PMID: 18405386
17.  Influence of two different resection techniques (conventional liver resection versus anterior approach) of liver metastases from colorectal cancer on hematogenous tumor cell dissemination – prospective randomized multicenter trial 
BMC Surgery  2008;8:6.
Background
Surgical hepatic resection remains the treatment of choice for patients with liver metastases from colorectal cancer despite the use of alternative therapeutic strategies. Although this procedure provides long-term survival in a significant number of patients, 50–75% of the patients develop intra- and/or extrahepatic recurrence. One possible reason for tumor recurrence may be intraoperative hematogenous tumor cell dissemination due to mechanical manipulation of the tumor during hepatic resection. Surgical technique may have an influence on hematogenous tumor cell spread. We hypothesize that hematogenous tumor cell dissemination may be reduced by using the anterior approach technique compared to conventional liver resection.
Methods/Design
This is a multi-centre prospective randomized controlled, superiority trial to compare two liver resection techniques of liver metastases from colorectal cancer. 150 patients will be included and randomized intraoperatively after surgical exploration just prior to resection. The primary objective is to compare the anterior approach with the conventional liver resection technique with regard to intraoperative haematogenous tumor cell dissemination. As secondary objectives we examine five year survival rates (OS and DFS), blood loss, duration of operation, requirement of blood transfusions, morbidity rate, prognostic relevance of tumor cell detection in blood and bone marrow and the comparison of tumor cell detection by different detection methods.
Conclusion
This trial will answer the question whether there is an advantage for the anterior approach technique compared to the conventional resection group with regard to tumor cell dissemination. It will also add further information about prognostic differences, safety, advantages and disadvantages of each technique.
Trial registration
Current controlled trials – ISRCTN45066244
doi:10.1186/1471-2482-8-6
PMCID: PMC2292146  PMID: 18321372
18.  Enhanced susceptibility to infections in a diabetic wound healing model 
BMC Surgery  2008;8:5.
Background
Wound infection is a common complication in diabetic patients. The progressive spread of infections and development of drug-resistant strains underline the need for further insights into bacterial behavior in the host in order to develop new therapeutic strategies. The aim of our study was to develop a large animal model suitable for monitoring the development and effect of bacterial infections in diabetic wounds.
Methods
Fourteen excisional wounds were created on the dorsum of diabetic and non-diabetic Yorkshire pigs and sealed with polyurethane chambers. Wounds were either inoculated with 2 × 108 Colony-Forming Units (CFU) of Staphylococcus aureus or injected with 0.9% sterile saline. Blood glucose was monitored daily, and wound fluid was collected for bacterial quantification and measurement of glucose concentration. Tissue biopsies for microbiological and histological analysis were performed at days 4, 8, and 12. Wounds were assessed for reepithelialization and wound contraction.
Results
Diabetic wounds showed a sustained significant infection (>105 CFU/g tissue) compared to non-diabetic wounds (p < 0.05) over the whole time course of the experiment. S. aureus-inoculated diabetic wounds showed tissue infection with up to 8 × 107 CFU/g wound tissue. Non-diabetic wounds showed high bacterial counts at day 4 followed by a decrease and no apparent infection at day 12. Epidermal healing in S. aureus-inoculated diabetic wounds showed a significant delay compared with non-inoculated diabetic wounds (59% versus 84%; p < 0.05) and were highly significant compared with healing in non-diabetic wounds (97%; p < 0.001).
Conclusion
Diabetic wounds developed significantly more sustained infection than non-diabetic wounds. S. aureus inoculation leads to invasive infection and significant wound healing delay and promotes invasive co-infection with endogenous bacteria. This novel wound healing model provides the opportunity to closely assess infections during diabetic wound healing and to monitor the effect of therapeutical agents in vivo.
doi:10.1186/1471-2482-8-5
PMCID: PMC2276479  PMID: 18312623
19.  The Quality Initiative in Rectal Cancer (QIRC) trial: study protocol of a cluster randomized controlled trial in surgery 
BMC Surgery  2008;8:4.
Background
Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC) strategy. The strategy is designed to optimize the use of total mesorectal excision techniques.
Methods and Design
Hospitals were randomized to the QIRC strategy (experimental group) versus normal practice environment (control group). Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of 2007.
Discussion
Lower rates of permanent colostomy and local tumour recurrence in the intervention arm would suggest the QIRC strategy is efficacious. The strategy may act as a template for efforts to improve surgical quality in other areas and will contribute to knowledge on influencing surgeon practice.
Trial registration
Current Controlled Trials ISRCTN78363167
doi:10.1186/1471-2482-8-4
PMCID: PMC2262058  PMID: 18279521
20.  Analysis of blood transfusion predictors in patients undergoing elective oesophagectomy for cancer 
BMC Surgery  2008;8:3.
Background
Oesophagectomy for cancers is a major operation with significant blood loss and usage. Concerns exist about the side effects of blood transfusion, cost and availability of donated blood. We are not aware of any previous study that has evaluated predictive factors for perioperative blood transfusion in patients undergoing elective oesophagectomy for cancer.
This study aimed to audit the pattern of blood crossmatch and to evaluate factors predictive of transfusion requirements in oesophagectomy patients.
Methods
Data was collected from the database of all patients who underwent oesophagectomy for cancer over a 2-year period. Clinico-pathological data collected included patients demographics, clinical factors, tumour histopathological data, preoperative and discharge haemoglobin levels, total blood loss, number of units of blood crossmatched pre-, intra- and postoperatively, number of blood units transfused, crossmatched units reused for another patient and number of blood units wasted.
Clinico-pathological variables were evaluated and logistic regression analysis was performed to determine which factors were predictive of blood transfusion.
Results
A total of 145 patients with a male to female ratio of 2.5:1 and median age of 68 (40–85) years were audited. The mean preoperative haemoglobin (Hb) was 13.0 g/dl. 37% of males (Hb < 13.0 g/dl) and 29% of females (Hb < 11.5 g/dl) were anaemic preoperatively. A total of 1241 blood units were crossmatched and 316 units were transfused to 71 patients. Seventy four patients (51%) did not require blood transfusion during their hospital episode. 846 blood units not used for oesophagectomy patients were reused for other patients and 79 units were wasted. The overall crossmatch to transfusion ratio was 4:1 and reuse and wastage rates were 65.2% and 6.3% respectively. The independent predictors of blood transfusion include age >70 years, Hb level <11.0 g/dl, T-stage, presence of postoperative complications and anastomotic leak.
Conclusion
The cohort of patients audited was over-crossmatched. The identified independent predictors of blood transfusion should be considered in preoperative blood ordering for oesophagectomy patients. This study has directly led to a reduction in the maximum surgical blood-ordering schedule for oesophagectomy to 2 units and a reaudit is underway.
doi:10.1186/1471-2482-8-3
PMCID: PMC2266902  PMID: 18221510
21.  PORTAL: Pilot study on the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection: a double-blind randomized placebo-controlled trial 
BMC Surgery  2008;8:2.
Background
Major surgical procedures facilitate systemic endotoxinemia and formation of free radicals with subsequent inflammatory changes that can influence the postoperative course. Experimental data suggest that preoperative supraphysiological doses of melatonin, a potent immuno-modulator and antioxidant, would decrease postoperative infectious and non-infectious complications induced by major abdominal surgery.
Methods/Design
A randomized controlled double blind single center clinical trial with two study arms comprising a total of 40 patients has been designed to assess the effects of a single preoperative dose of melatonin before major liver resection. Primary endpoints include the determination of safety and tolerance of the regimen as well as clinical parameters reflecting pathophysiological functions of the liver. Furthermore, data on clinical outcome (infectious and non-infectious complications) will be collected as secondary endpoints to allow a power calculation for a randomized clinical trial aiming at clinical efficacy.
Discussion
Based on experimental data, this ongoing clinical trial represents an advanced element of the research chain from bench to bedside in order to reach the highest level of evidence-based clinical facts to determine if melatonin can improve the general outcome after liver resection.
Trial Registration
EudraCT200600530815
doi:10.1186/1471-2482-8-2
PMCID: PMC2248566  PMID: 18215253
22.  Local radiotherapy of exposed murine small bowel: Apoptosis and inflammation 
BMC Surgery  2008;8:1.
Background
Preoperative radiotherapy of the pelvic abdomen presents with complications mostly affecting the small bowel. The aim of this study was to define the features of early radiation-induced injury on small bowel.
Methods
54 mice were divided into two groups (36 irradiated and 18 sham irradiated). Animals were placed on a special frame and (in the radiated group) the exteriorized segment of ileum was subjected to a single absorbed dose of 19 or 38 Gy radiation using 6 MV high energy photons. Specimens were collected for histology, immunohistochemistry (IHC) and ELISA analysis after 2, 24 and 48 hours. Venous blood was collected for systemic leucocyte count in a Burker chamber.
Results
Histology demonstrated progressive infiltration of inflammatory cells with cryptitis and increased apoptosis. MIP-2 (macrophage inflammatory protein) concentration was significantly increased in irradiated animals up to 48 hours. No significant differences were observed in IL-10 (interleukin) and TNF-α (tumour necrosis factor) levels. IHC with CD45 showed a significant increase at 2 hours of infiltrating leucocytes and lymphocytes after irradiation followed by progressive decrease with time. Caspase-3 expression increased significantly in a dose dependent trend in both irradiated groups up to 48 hours.
Conclusion
Acute small bowel injury caused by local irradiation is characterised by increased apoptosis of crypt epithelial cells and by lymphocyte infiltration of the underlying tissue. The severity of histological changes tends to be dose dependent and may affect the course of tissue damage.
doi:10.1186/1471-2482-8-1
PMCID: PMC2248567  PMID: 18173838

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