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1.  Integrated approach to colorectal anastomotic leakage: Communication, infection and healing disturbances 
World Journal of Gastroenterology  2016;22(32):7226-7235.
Colorectal anastomotic leakage (CAL) remains a major complication after colorectal surgery. Despite all efforts during the last decades, the incidence of CAL has not decreased. In this review, we summarize the available strategies regarding prevention, prediction and intervention of CAL and categorize them into three categories: communication, infection and healing disturbances. These three major factors actively interact during the onset of CAL. We aim to provide an integrated approach to CAL based on its etiology. The intraoperative air leak test, intraoperative endoscopy, radiological examinations and stoma construction mainly aim to detect and to prevent communication between the intra- and extra-luminal content. Other strategies including postoperative drainage, antibiotics, and infectious-parameter evaluation are intended to detect and prevent anastomotic or peritoneal infection. Most currently available interventions for CAL focus on the control of communication and infection, while strategies targeting the healing disturbances such as lifestyle changes, oxygen therapy and evaluation of metabolic biomarkers still lack wide clinical application. This simplified categorization may contribute to an integrated understanding of CAL. We strongly believe that this integrated approach should be taken into consideration during clinical practice. An integrated approach to CAL could contribute to a better understanding of the etiology of CAL and eventually better patient outcome.
PMCID: PMC4997633  PMID: 27621570
Colorectal anastomotic leakage; Integrated approach; Prevention; Prediction; Intervention
2.  Is the intraoperative air leak test effective in the prevention of colorectal anastomotic leakage? A systematic review and meta-analysis 
The intra-operative air leak test (ALT) is a common intraoperative test used to identify mechanically insufficient anastomosis. This meta-analysis aims to determine whether ALT aids to the reduction of postoperative colorectal anastomotic leakage (CAL).
A literature search was performed to select studies in acknowledged databases. Full text articles targeting ALT during colorectal surgery were included. Quality assessment, risk of bias, and the level-of-evidence of the inclusions were evaluated. ALT methodology, ALT(+) (i.e., leak observed during the test) rate, and postoperative CAL rate of the included studies were subsequently analyzed.
Twenty studies were included for analysis, in which we found substantial risks of bias. A lower CAL rate was observed in patients who underwent ALT than those did not; however, the difference was not significant (p = 0.15). The intraoperative ALT(+) rate greatly varied among the included studies from 1.5 to 24.7 %. ALT(+) patients possessed a significantly higher CAL rate than the ALT(−) patients (11.4 vs. 4.2 %, p < 0.001).
Based on the available evidence, performing an ALT with the reported methodology has not significantly reduced the clinical CAL rate but remains necessary due to a higher risk of CAL in ALT(+) cases. Unfortunately, additional repairs under current methods may not effectively decrease this risk. Results of this review urge a standardization of ALT methodology and effective methods to repair ALT(+) anastomoses.
PMCID: PMC4947486  PMID: 27294661
Anastomotic leakage; Colorectal surgery; Air leak test; Prevention
3.  Cytokines as Early Markers of Colorectal Anastomotic Leakage: A Systematic Review and Meta-Analysis 
Purpose. Colorectal anastomotic leakage (CAL) is one of the most severe complications after colorectal surgery. This meta-analysis evaluates whether systemic or peritoneal inflammatory cytokines may contribute to early detection of CAL. Methods. Systematic literature search was performed in the acknowledged medical databases according to the PRISMA guidelines to identify studies evaluating systemic and peritoneal levels of TNF, IL-1β, IL-6, and IL-10 for early detection of CAL. Means and standard deviations of systemic and peritoneal cytokine levels were extracted, respectively, for patients with and without CAL. The meta-analysis of the mean differences was carried out for each postoperative day using Review Manager. Results. Seven articles were included. The meta-analysis was performed with 5 articles evaluating peritoneal cytokine levels. Peritoneal levels of IL-6 were significantly higher in patients with CAL compared to patients without CAL on postoperative days 1, 2, and 3 (P < 0.05). Similar results were found for peritoneal levels of TNF but on postoperative days 3, 4, and 5 (P < 0.05). The articles regarding systemic cytokine levels did not report any significant difference accordingly. Conclusion. Increased postoperative levels of peritoneal IL-6 and TNF are significantly associated with CAL and may contribute to its early detection.
PMCID: PMC4804081  PMID: 27051416
4.  The Effect of Biomaterials Used for Tissue Regeneration Purposes on Polarization of Macrophages 
BioResearch Open Access  2016;5(1):6-14.
Activation of macrophages is critical in the acute phase of wound healing after implantation of surgical biomaterials. To understand the response of macrophages, they are often cultured in vitro on biomaterials. Since a wide range of biomaterials is currently used in the clinics, we undertook a systematic review of the macrophage polarization in response to these different surgical biomaterials in vitro. Beside the chemistry, material characteristics such as dimension, pore size, and surface topography are of great influence on the response of macrophages. The macrophage response also appears to depend on the differences in sterilization techniques that induce lasting biochemical changes or residues of chemicals and their byproducts used for sterilization. Regarding tissue-based biomaterials, macrophages on human or porcine dermis, strongly cross-linked by chemicals elicit in general a proinflammatory response with higher amounts of proinflammatory cytokines. Synthetic biomaterials such as polyethylene, polyethylene terephthalate (PET) + polyacrylamide (PAAm), PET + sodium salt of poly(acrylic acid) (PAANa), perfluoropolyether (PFPE) with large posts, PEG-g-PA, and polydioxanone (PDO) always appear to elicit an anti-inflammatory response in macrophages, irrespective of origin of the macrophages, for example, buffy coats or full blood. In conclusion, in general in vitro models contribute to evaluate the foreign body reaction on surgical biomaterials. Although it is difficult to simulate complexity of host response elicited by biomaterials, after their surgical implantation, an in vitro model gives indications of the initial foreign body response and allows the comparison of this response between biomaterials.
PMCID: PMC4744891  PMID: 26862468
biomaterials; in vitro models; macrophage response; review
5.  Acute laparoscopic and open sigmoidectomy for perforated diverticulitis: a propensity score-matched cohort 
Surgical Endoscopy  2015;30:3889-3896.
Hartmann’s procedure for perforated diverticulitis can be characterised by high morbidity and mortality rates. While the scientific community focuses on laparoscopic lavage as an alternative for laparotomy, the option of laparoscopic sigmoidectomy seems overlooked. We compared morbidity and hospital stay following acute laparoscopic sigmoidectomy (LS) and open sigmoidectomy (OS) for perforated diverticulitis.
This retrospective cohort parallel to the Ladies trial included patients from 28 Dutch academic or teaching hospitals between July 2010 and July 2014. Patients with LS were matched 1:2 to OS using the propensity score for age, gender, previous laparotomy, CRP level, gastrointestinal surgeon, and Hinchey classification.
The propensity-matched cohort consisted of 39 patients with LS and 78 patients with OS, selected from a sample of 307 consecutive patients with purulent or faecal perforated diverticulitis. In both groups, 66 % of the patients had Hartmann’s procedure and 34 % had primary anastomosis. The hospital stay was shorter following LS (LS 7 vs OS 9 days; P = 0.016), and the postoperative morbidity rate was lower following LS (LS 44 % vs OS 66 %; P = 0.016). Mortality was low in both groups (LS 3 % vs OS 4 %; P = 0.685). The stoma reversal rate after Hartmann’s procedure was higher following laparoscopy, with a probability of being stoma-free at 12 months of 88 and 62 % in the laparoscopic and open groups, respectively (P = 0.019). After primary anastomosis, the probability of reversal was 100 % in both groups.
In this propensity score-matched cohort, laparoscopic sigmoidectomy is superior to open sigmoidectomy for perforated diverticulitis with regard to postoperative morbidity and hospital stay.
Electronic supplementary material
The online version of this article (doi:10.1007/s00464-015-4694-8) contains supplementary material, which is available to authorized users.
PMCID: PMC4992031  PMID: 26679173
Diverticulitis; Laparoscopy; Sigmoid resection; Perforated diverticulitis; Propensity score
6.  Early weaning in idiopathic scoliosis 
Scoliosis  2015;10:32.
Many years of bracing represent a burden to the patients. Early weaning may be the result of poor compliance, but may also be planned in patients with a long expected treatment time and a reduced stable primary curve during bracing. The aim of the present cohort study was to compare curve size, health related quality of life and surgical rates at long-term follow-up after ordinary bracing, planned and unplanned early weaning.
Three hundred eighty-one patients (353 girls/28 boys) with late-onset juvenile (n = 30) and adolescent (n = 351) idiopathic scoliosis and a mean primary major curve of 33.1 (range 20–57)° were treated with Boston brace and followed prospectively.
Ordinary brace treatment was completed in 290 (76 %) patients, planned early weaning at bone age <14 years in 59 (16 %), and unplanned early weaning in 32 (8 %), while 14 (5 %), 1 (2 %), and 12 (38 %) had surgery, respectively. Forty-eight (81 %) of the patients had a primary curve ≤ 25° at planned early weaning. Six-teen (27 %) of those who had planned early weaning, resumed bracing after a mean time of 2.0 years. The mean curve size at long-term follow-up in average 23.4 years after weaning, was smaller (p < 0.001) in patients with planned early weaning (25.1°) compared with ordinary bracing (34.0°) and unplanned early weaning (34.8°). Patient satisfaction and self-image at long-term was better in the planned early weaning group (p < 0.05), but differences were small.
The benefit of planned early weaning was the shortened bracing time and good clinical results. This procedure may be attempted if curve reduction is stable over time and the primary curve is 25° or less in patients with several years of expected bracing. The patients should be monitored carefully and regularly at 4-6 months intervals until maturity, and a new brace should be prepared if the curve increases significantly.
PMCID: PMC4652388  PMID: 26587052
Idiopathic scoliosis; Scoliosis treatment; Brace weaning; Curve progression
7.  Multimodal treatment of perianal fistulas in Crohn’s disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial 
Trials  2015;16:366.
Currently there is no guideline for the treatment of patients with Crohn’s disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs.
This is a multicentre, randomized controlled trial. Patients with Crohn’s disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs.
The PISA trial is a multicentre, randomised controlled trial of patients with Crohn’s disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters.
Trial registration
Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0831-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4545975  PMID: 26289163
Crohn’s disease; Perianal fistula; Seton; Anti-TNF; Advancement plasty; Quality of life; Cost-effectiveness
8.  Prediction and diagnosis of colorectal anastomotic leakage: A systematic review of literature 
Although many studies have focused on the preoperative risk factors of anastomotic leakage after colorectal surgery (CAL), postoperative delay in diagnosis is common and harmful. This review provides a systematic overview of all available literature on diagnostic tools used for CAL. A systematic search of literature was undertaken using Medline, Embase, Cochrane and Web-of-Science libraries. Articles were selected when a diagnostic or prediction tool for CAL was described and tested. Two reviewers separately assessed the eligibility and level of evidence of the papers. Sixty-nine articles were selected (clinical methods: 11, laboratory tests: 12, drain fluid analysis: 12, intraoperative techniques: 22, radiology: 16). Clinical scoring leads to early awareness of probability of CAL and reduces delay of diagnosis. C-reactive protein measurement at postoperative day 3-4 is helpful. CAL patients are characterized by elevated cytokine levels in drain fluid in the very early postoperative phase in CAL patients. Intraoperative testing using the air leak test allows intraoperative repair of the anastomosis. Routine contrast enema is not recommended. If CAL is clinically suspected, rectal contrast-computer tomography is recommended by a few studies. In many studies a “no-test” control group was lacking, furthermore no golden standard for CAL is available. These two factors contributed to a relatively low level of evidence in the majority of the papers. This paper provides a systematic overview of literature on the available tools for diagnosing CAL. The study shows that colorectal surgery patients could benefit from some diagnostic interventions that can easily be performed in daily postoperative care.
PMCID: PMC3942535  PMID: 24600507
Colorectal; Anastomosis; Leakage; Diagnosis; Prediction
9.  Force Sensing in Surgical Sutures 
PLoS ONE  2013;8(12):e84466.
The tension in a suture is an important factor in the process of wound healing. If there is too much tension in the suture, the blood flow is restricted and necrosis can occur. If the tension is too low, the incision opens up and cannot heal properly. The purpose of this paper is to describe the design and evaluation of the Stitch Force (SF) sensor and the Hook-In Force (HIF) sensor. These sensors were developed to measure the force on a tensioned suture inside a closed incision and to measure the pulling force used to close the incision. The accuracy of both sensors is high enough to determine the relation between the force in the thread of a stitch and the pulling force applied on the suture by the physician. In a pilot study, a continuous suture of 7 stitches was applied on the fascia of the abdominal wall of multiple pigs to study this relationship. The results show that the max force in the thread of the second stitch drops from 3 (SD 1.2) to 1 (SD 0.3) newton after the 4th stitch was placed. During placement of the 5th, 6th and 7th stitch, the force in the 2nd stitch was not influenced anymore. This study indicates that in a continuous suture the force in the thread remains constant up to more than 3 stiches away from the pulled loose end of the suture. When a force feedback tool is developed specially for suturing in surgery on patients, the proposed sensors can be used to determine safety threshold for different types of tissue and sutures.
PMCID: PMC3871579  PMID: 24376812
10.  A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence 
BMC Surgery  2013;13:48.
Incisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality. The overall incidence remains 11-20%, despite studies attempting to optimize closing techniques. Two patient groups, patients with abdominal aortic aneurysm and obese patients, have a risk for incisional hernia after laparotomy of more than 30%. These patients might benefit from mesh augmented midline closure as a means to reduce incisional hernia incidence.
The PRImary Mesh Closure of Abdominal Midline Wound (PRIMA) trial is a double-blinded international multicenter randomized controlled trial comparing running slowly absorbable suture closure with the same closure augmented with a sublay or onlay mesh. Primary endpoint will be incisional hernia incidence 2 years postoperatively. Secondary outcomes will be postoperative complications, pain, quality of life and cost effectiveness.
A total of 460 patients will be included in three arms of the study and randomized between running suture closure, onlay mesh closure or sublay mesh closure. Follow-up will be at 1, 3, 12 and 24 months with ultrasound imaging performed at 6 and 24 months to objectify the presence of incisional hernia. Patients, investigators and radiologists will be blinded throughout the whole follow up.
The use of prosthetic mesh has proven effective and safe in incisional hernia surgery however its use in a prophylactic manner has yet to be properly investigated. The PRIMA trial will provide level 1b evidence whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups.
Trial registration
Clinical NCT00761475.
PMCID: PMC3840708  PMID: 24499111
11.  Good brace compliance reduced curve progression and surgical rates in patients with idiopathic scoliosis 
European Spine Journal  2012;21(10):1957-1963.
To examine the association between brace compliance and outcome.
Patients and methods
495 (457 females) patients with late onset juvenile and adolescent idiopathic scoliosis were examined prospectively before bracing and at least 2 years after brace weaning. One spine surgeon examined all patients. 381 (353 females) answered a standardised questionnaire and 355 had radiological examination after median 24 years. Compliance was defined as brace wear >20 h daily until weaning. Main outcomes were curve progression and surgery.
At weaning, 76/389 compliers and 59/106 non-compliers had curve progression ≥6° (OR 5.2, 95 % CI 3.3–8.2). At long-term the numbers were 68/284 and 46/71 (OR 5.8, 95 % CI 3.3–10.2), 10/284 versus 17/71 had been operated (OR 8.6, 95 % CI 3.7–19.9).
We conclude that the risk for curve progression and surgery are reduced in patients with good brace compliance.
PMCID: PMC3463688  PMID: 22661234
Idiopathic scoliosis; Bracing; Compliance; Curve progression; Surgery
12.  The INCH-Trial: a multicentre randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional hernia repair 
BMC Surgery  2013;13:18.
Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the ‘INCH-trial’, comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed.
A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.
Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life.
The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life.
The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach.
Trial registration
Netherlands Trial register: NTR2808
PMCID: PMC3680330  PMID: 24499061
13.  Colorectal anastomotic leakage: Aspects of prevention, detection and treatment 
All colorectal surgeons are faced from time to time with anastomotic leakage after colorectal surgery. This complication has been studied extensively without a significant reduction of incidence over the last 30 years. New techniques of prevention, by innovative anastomotic techniques should improve results in the future, but standardization and “teachability” should be guaranteed. Risk scoring enables intra-operative decision-making whether to restore continuity or deviate. Early detection can lead to reduction in delay of diagnosis as long as a standard system is used. For treatment options, no firm evidence is available, but future studies could focus on repair and saving of the anastomosis on the one hand or anastomotical breakdown and definitive colostomy on the other hand.
PMCID: PMC3631979  PMID: 23613621
Colorectal surgery; Complications; Postoperative care; Anastomotic leakage; Prevention
14.  Training in laparoscopic colorectal surgery: a new educational model using specially embalmed human anatomical specimen 
Surgical Endoscopy  2012;26(8):2189-2194.
With an increasing percentage of colorectal resections performed laparoscopically nowadays, there is more emphasis on training “before the job” on operative skills, including the comprehension of specific laparoscopic surgical anatomy. As integration of technical skills with correct interpretation of the anatomical image must be incorporated in laparoscopic training, a human specimen training model with special emphasis on surgical anatomy was developed.
The new embalming method Anubifix™ combines long-term high-quality embalming of human bodies with almost normal flexibility and plasticity, and the body can be kept operational as long as conventionally embalmed human specimens. A colorectal training model was created in a specimen in which anatomical landmarks of colorectal anatomy were permanently colored to explore laparoscopic colorectal anatomy in a skills training setting. Airtight closure of the abdominal wall permits the creation of pneumoperitoneum. Residents were asked to test the model by mobilizing the small and large bowels and expose the central vessels and ureters. Afterward they were asked to fill out an eight-item questionnaire about the model.
Eleven surgical residents in their first and second year of training participated. Responses to the questionnaire showed that a majority of residents considered the model to be representative of the real situation and superior to animal models or virtual reality simulators, and helped to improve the knowledge of three-dimensional anatomy and laparoscopic skills.
The new training model for laparoscopic colorectal surgery proved to be a high-quality tool, concentrating on laparoscopic colorectal anatomy in a skills training setting. We believe it may be a valuable adjunct to residency training programs based on the principle of “training before the job.”
PMCID: PMC3392504  PMID: 22286275
Abdominal; Laparoscopic education; Training; Colorectal surgery; Gastrointestinal
15.  Long-term results after Boston brace treatment in late-onset juvenile and adolescent idiopathic scoliosis 
Scoliosis  2011;6:18.
It is recommended that research in patients with idiopathic scoliosis should focus on short- and long-term patient-centred outcome. The aim of the present study was to evaluate outcome in patients with late-onset juvenile or adolescent idiopathic scoliosis 16 years or more after Boston brace treatment.
272 (78%) of 360 patients, 251 (92%) women, responded to follow-up examination at a mean of 24.7 (range 16 - 32) years after Boston brace treatment. Fifty-eight (21%) patients had late-onset juvenile and 214 had adolescent idiopathic scoliosis. All patients had clinical and radiological examination and answered a standardised questionnaire including work status, demographics, General Function Score (GFS) (100 - worst possible) and Oswestry Disability Index (ODI) (100 - worst possible), EuroQol (EQ-5D) (1 - best possible), EQ-VAS (100 - best possible), and Scoliosis Research Society - 22 (SRS - 22) (5 - best possible).
The mean age at follow-up was 40.4 (31-48) years. The prebrace major curve was in average 33.2 (20 - 57)°. At weaning and at the last follow-up the corresponding values were 28.3 (1 - 58)° and 32.5 (7 - 80)°, respectively. Curve development was similar in patients with late-onset juvenile and adolescent start. The prebrace curve increased > 5° in 31% and decreased > 5° in 26%. Twenty-five patients had surgery. Those who did not attend follow-up (n = 88) had a lower mean curve at weaning: 25.4 (6-53)°. Work status was 76% full-time and 10% part-time. Eighty-seven percent had delivered a baby, 50% had pain in pregnancy. The mean (SD) GFS was 7.4 (10.8), ODI 9.3 (11.0), EQ-5D 0.82 (0.2), EQ-VAS 77.6 (17.8), SRS-22: pain 4.1 (0.8), mental health 4.1 (0.6), self-image 3.7 (0.7), function 4.0 (0.6), satisfaction with treatment 3.7 (1.0). Surgical patients had significantly reduced scores for SRS-physical function and self-image, and patients with curves ≥ 45° had reduced self-image.
Long-term results were satisfactory in most braced patients and similar in late-onset juvenile and idiopathic adolescent scoliosis.
PMCID: PMC3189160  PMID: 21880123
16.  A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions 
BMC Surgery  2011;11:20.
The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure.
The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life.
A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure.
The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique.
Trial registration NCT01132209
PMCID: PMC3182877  PMID: 21871072
18.  High tie versus low tie in rectal surgery: comparison of anastomotic perfusion 
Both “high tie” (HT) and “low tie” (LT) are well-known strategies in rectal surgery. The aim of this study was to compare colonic perfusion after HT to colonic perfusion after LT.
Patients undergoing rectal resection for malignancy were included. Colonic perfusion was measured with laser Doppler flowmetry, immediately after laparotomy on the antimesenterial side of the colon segment that was to become the afferent loop (measurement A). This measurement was repeated after rectal resection (measurement B). The blood flow ratios (B/A) were compared between the HT group and the LT group.
Blood flow was measured in 33 patients, 16 undergoing HT and 17 undergoing LT. Colonic blood flow slightly decreased in the HT group whereas the flow increased in the LT group. The blood flow ratio was significantly higher in the LT group (1.48 vs. 0.91; p = 0.04), independent of the blood pressure.
This study shows the blood flow ratio to be higher in the LT group. This suggests that anastomoses may benefit from better perfusion when LT is performed.
PMCID: PMC3140934  PMID: 21445553
High tie; Low tie; Perfusion; Colorectal surgery; Anastomosis
19.  The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037) 
BMC Surgery  2010;10:29.
Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.
The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis).
In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.
The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.
Trial registration
Nederlands Trial Register NTR2037
PMCID: PMC2974662  PMID: 20955571
20.  A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial) 
BMC Surgery  2010;10:23.
Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects.
A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included.
A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach.
Trial registration
Trial registration number: NCT01111253
PMCID: PMC2919453  PMID: 20646266
21.  Avoiding or Reversing Hartmann’s Procedure Provides Improved Quality of Life After Perforated Diverticulitis 
The existing literature regarding acute perforated diverticulitis only reports about short-term outcome; long-term following outcomes have not been assessed before. The aim of this study was to assess long-term quality of life (QOL) after emergency surgery for perforated diverticulitis.
Patients and Methods
Validated QOL questionnaires (EQ-VAS, EQ-5D index, QLQ-C30, and QLQ-CR38) were sent to all eligible patients who had undergone emergency surgery for perforated diverticulitis in five teaching hospitals between 1990 and 2005. Differences were compared between patients that had undergone Hartmann’s procedure (HP) or resection with primary anastomosis (PA) and also compared to a sex- and age-matched sample of healthy subjects.
Of a total of 340 patients, only 150 patients (44%) were found still alive in July 2007 (median follow-up 71 months). The response rate was 87%. In patients with PA, QOL was similar to the general population, whereas QOL after HP was significantly lower. The presence of a stoma was found to be an independent factor related to worse QOL. The deterioration in QOL was mainly due to problems in physical function and body image.
Survivors after perforated diverticulitis had a worse QOL than the general population, which was mainly due to the presence of an end colostomy. QOL may improve if these stomas are reversed or not be performed in the first place.
PMCID: PMC2836251  PMID: 20127201
Perforated diverticulitis; Quality of life; Hartmann’s procedure; Primary anastomosis
22.  Evaluation of Operative Notes Concerning Laparoscopic Cholecystectomy: Are Standards Being Met? 
World Journal of Surgery  2010;34(5):903-909.
Laparoscopic cholecystectomy (LC) is the most performed minimal invasive surgical procedure and has a relatively high complication rate. As complications are often revealed postoperatively, clear, accurate, and timely written operative notes are important in order to recall the procedure and start follow-up treatment as soon as possible. In addition, the surgeon’s operative notes are important to assure surgical quality and communication with other healthcare providers. The aim of the present study was to assess compliance with the Dutch guidelines for writing operative notes for LC.
Nine hospitals were asked to send 20 successive LC operative notes. All notes were compared to the Dutch guideline by two reviewers and double-checked by a third reviewer. Statistical analyses on the “not described” items were performed.
All hospitals participated. Most notes complied with the Dutch guideline (52–69%); 19–30% of items did not comply. Negative scores for all hospitals were found, mainly for lacking a description of the patient’s posture (average 69%), bandage (94%), blood loss (98%), name of the scrub nurse (87%), postoperative conclusion (65%), and postoperative instructions (78%). Furthermore, notes from one community hospital and two teaching hospitals complied significantly less with the guidelines.
Operative notes do not always fully comply with the standards set forth in the guidelines published in the Netherlands. This could influence adjuvant treatment and future patient treatment, and it may make operative notes less suitable background for other purposes. Therefore operative note writing should be taught as part of surgical training, definitions should be provided, and procedure-specific guidelines should be established to improve the quality of the operative notes and their use to improve patient safety.
PMCID: PMC2848728  PMID: 20112020
23.  Treatment of Perforated Diverticulitis with Generalized Peritonitis: Past, Present, and Future 
World Journal of Surgery  2010;34(3):587-593.
The supposed optimal treatment of perforated diverticulitis with generalized peritonitis has changed several times during the last century, but at present is still unclear.
The first cases of complicated perforated diverticulitis of the colon were reported in the beginning of the twentieth century. At that time the first therapeutic guidelines were postulated in which an initial nonresectional procedure was provided to be the safest plan of management. After many years in which resection had become standard practice, today, one century later, again (laparoscopic) nonresectional surgery is presented as a safe and promising alternative in treatment of complicated perforated diverticulitis. The question rises what had happened to close the circle?
This paper includes a historic summary of changing patterns in surgical strategies in perforated diverticulitis complicated by generalized peritonitis.
PMCID: PMC2816807  PMID: 20052468
24.  Laparoscopic correction of perforated peptic ulcer: first choice? A review of literature 
Surgical Endoscopy  2009;24(6):1231-1239.
Perforated peptic ulcer (PPU), despite antiulcer medication and Helicobacter eradication, is still the most common indication for emergency gastric surgery associated with high morbidity and mortality. Outcome might be improved by performing this procedure laparoscopically, but there is no consensus on whether the benefits of laparoscopic closure of perforated peptic ulcer outweigh the disadvantages such as prolonged surgery time and greater expense.
An electronic literature search was done by using PubMed and EMBASE databases. Relevant papers written between January 1989 and May 2009 were selected and scored according to Effective Public Health Practice Project guidelines.
Data were extracted from 56 papers, as summarized in Tables 1–7. The overall conversion rate for laparoscopic correction of perforated peptic ulcer was 12.4%, with main reason for conversion being the diameter of perforation. Patients presenting with PPU were predominantly men (79%), with an average age of 48 years. One-third had a history of peptic ulcer disease, and one-fifth took nonsteroidal anti-inflammatory drugs (NSAIDs). Only 7% presented with shock at admission. There seems to be no consensus on the perfect setup for surgery and/or operating technique. In the laparoscopic groups, operating time was significant longer and incidence of recurrent leakage at the repair site was higher. Nonetheless there was significant less postoperative pain, lower morbidity, less mortality, and shorter hospital stay.
There are good arguments that laparoscopic correction of PPU should be first treatment of choice. A Boey score of 3, age over 70 years, and symptoms persisting longer than 24 h are associated with higher morbidity and mortality and should be considered contraindications for laparoscopic intervention.
PMCID: PMC2869436  PMID: 20033725
Laparoscopic surgery; Perforated peptic ulcer; Omentoplasty; Review
25.  Abdominal Wound Dehiscence in Adults: Development and Validation of a Risk Model 
World Journal of Surgery  2009;34(1):20-27.
Several studies have been performed to identify risk factors for abdominal wound dehiscence. No risk model had yet been developed for the general surgical population. The objective of the present study was to identify independent risk factors for abdominal wound dehiscence and to develop a risk model to recognize high-risk patients. Identification of high-risk patients offers opportunities for intervention strategies.
Medical registers from January 1985 to December 2005 were searched. Patients who had primarily undergone appendectomies or nonsurgical (e.g., urological) operations were excluded. Each patient with abdominal wound dehiscence was matched with three controls by systematic random sampling. Putative relevant patient-related, operation-related, and postoperative variables were evaluated in univariate analysis and subsequently entered in multivariate stepwise logistic regression models to delineate major independent predictors of abdominal wound dehiscence. A risk model was developed, which was validated in a population of patients who had undergone operation between January and December 2006.
A total of 363 cases and 1,089 controls were analyzed. Major independent risk factors were age, gender, chronic pulmonary disease, ascites, jaundice, anemia, emergency surgery, type of surgery, postoperative coughing, and wound infection. In the validation population, risk scores were significantly higher (P < 0.001) for patients with abdominal wound dehiscence (n = 19) compared to those without (n = 677). Resulting scores ranged from 0 to 8.5, and the risk for abdominal wound dehiscence over this range increased exponentially from 0.02% to 70.1%.
The validated risk model shows high predictive value for abdominal wound dehiscence and may help to identify patients at increased risk.
PMCID: PMC2795859  PMID: 19898894

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