Simon W. Nienhuijs

Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis : a multicentre, parallel-group, randomised, open-label trial

BACKGROUND Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. METHODS We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmanns procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmanns procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. FINDINGS Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). INTERPRETATION Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. FUNDING Netherlands Organisation for Health Research and Development.

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)

BackgroundRecently, 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).Methods/DesignIn this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmanns 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 Hartmanns 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.DiscussionThe 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 registrationNederlands Trial Register NTR2037

Peritoneal carcinomatosis of gastric origin: A population-based study on incidence, survival and risk factors

Peritoneal carcinomatosis (PC) is an important cause of morbidity and mortality among patients with gastric cancer. The aim of the current study was to provide reliable population‐based data on the incidence, risk factors and prognosis of PC of gastric origin. All patients diagnosed with gastric cancer in the area of the Eindhoven Cancer Registry between 1995 and 2011 were included. Incidence and survival were computed and risk factors for peritoneal carcinomatosis were determined using multivariate logistic regression analysis. In total, 5,220 patients were diagnosed with gastric cancer, of whom 2,029 (39%) presented with metastatic disease. PC was present in 706 patients (14%) of whom 491 patients (9%) had PC as the only metastatic site. Younger age (<60 years), female gender, advanced T‐ and N‐stage, primary tumor of signet ring cells or linitis plastica and primary tumors covering multiple anatomical locations of the stomach were all associated with a higher odds ratios of developing PC. Median survival of patients without metastases was 14 months, but only 4 months for patients with PC. PC is a frequent condition in patients presenting with gastric cancer, especially in younger patients with advanced tumor stages. Given the detrimental influence of PC on survival, efforts should be undertaken to further explore the promising results that were obtained in preventing or treating this condition with multimodality strategies.

Early experience with laparoscopic lavage for perforated diverticulitis

Laparoscopic lavage has recently emerged as a promising alternative to sigmoid resection in the treatment of perforated diverticulitis. This study examined an early experience with this technique.

Peritoneal carcinomatosis of colorectal origin: Incidence, prognosis and treatment options

Peritoneal carcinomatosis (PC) is one manifestation of metastatic colorectal cancer (CRC). Tumor growth on intestinal surfaces and associated fluid accumulation eventually result in bowel obstruction and incapacitating levels of ascites, which profoundly affect the quality of life for affected patients. PC appears resistant to traditional 5-fluorouracil-based chemotherapy, and surgery was formerly reserved for palliative purposes only. In the absence of effective treatment, the historical prognosis for these patients was extremely poor, with an invariably fatal outcome. These poor outcomes likely explain why PC secondary to CRC has received little attention from oncologic researchers. Thus, data are lacking regarding incidence, clinical disease course, and accurate treatment evaluation for patients with PC. Recently, population-based studies have revealed that PC occurs relatively frequently among patients with CRC. Risk factors for developing PC have been identified: right-sided tumor, advanced T-stage, advanced N-stage, poor differentiation grade, and younger age at diagnosis. During the past decade, both chemotherapeutical and surgical treatments have achieved promising results in these patients. A chance for long-term survival or even cure may now be offered to selected patients by combining radical surgical resection with intraperitoneal instillation of heated chemotherapy. This combined procedure has become known as hyperthermic intraperitoneal chemotherapy. This editorial outlines recent advancements in the medical and surgical treatment of PC and reviews the most recent information on incidence and prognosis of this disease. Given recent progress, treatment should now be considered in every patient presenting with PC.

Pain after Open Preperitoneal Repair versus Lichtenstein Repair: A Randomized Trial

BackgroundThe open preperitoneal approach in inguinal hernia repair might have the benefit of a mesh in the preferred space without the disadvantages of an endoscopic procedure.MethodsA total of 172 patients with primary inguinal hernia were randomized to undergo the open preperitoneal Kugel or the standard open anterior Lichtenstein procedure in a teaching hospital. The main outcome measures were operating variables, visual analog scale (VAS) pain scores, and consumed analgesics during the first 2 weeks postoperatively and at 3 months, neurological examination, and complications.ResultsIn the Lichtenstein group the operation took longer (54 min versus 41 min; p < .001). There were no clinically important differences in VAS pain score or number of analgesics during the first 2 weeks postoperatively. In the Kugel group the mean VAS pain score at 3 months was less (0.3 versus 0.9; p = .002), as was the proportion of patients reporting pain (21 versus 40%; p = .007). Pain was merely described as neuropathic, especially in the Lichtenstein group. With the anterior repair significantly more nerves were encountered, numbness reported, and cutaneous sensory changes found with neurological examination (all p < .001).ConclusionsFor those surgeons preferring an open approach, the Kugel procedure is a feasible alternative for the standard Lichtenstein procedure and is associated with less chronic pain at three months. Most likely the neuropathic pain and numbness with the Lichtenstein technique are results of more nerves at risk with the anterior approach.

Incidence, prognosis, and possible treatment strategies of peritoneal carcinomatosis of pancreatic origin: a population-based study.

Objectives Peritoneal carcinomatosis (PC) is an important cause of morbidity and mortality among patients with pancreatic cancer. In an era where therapeutic options for PC of multiple origins are emerging, our aim was to provide population-based data on incidence, treatment, and prognosis of PC of pancreatic origin. Methods All patients with a condition diagnosed as nonendocrine pancreatic cancer between 1995 and 2009 in the area of the Eindhoven Cancer Registry were included. Results In total, 2924 patients had a diagnosis of pancreatic cancer of which 265 patients (9%) presented with synchronous PC. An increasing trend could be noted in patients treated with chemotherapy in more recent years (11% in 1995–1999 and 22% in 2005–2009; P = 0.060). Median survival in patients presenting with PC was only 6 weeks (95% confidence interval, 5–7 weeks) and did not improve over time, contrasting improvements among patients with nonmetastasized disease (19–30 weeks) and patients with metastasized disease confined to the liver (8–12 weeks). Conclusion Prognosis of patients with pancreatic cancer presenting with PC remains extremely poor. Treatment options are scarce and, given the magnitude of the problem, efforts should be undertaken to develop effective treatments in experimental and clinical studies.

Technology-based interventions in the treatment of overweight and obesity: A systematic review

The prevalence of obesity increases worldwide. The use of technology-based interventions can be beneficial in weight loss interventions. This review aims to provide insight in the effectiveness of technology-based interventions on weight loss and quality of life for patients suffering overweight or obesity compared to standard care. Pubmed, PsycInfo, Web of Science, ScienceDirect, CINAHL and Embase were searched from the earliest date (of each database) up to February 2015. Interventions needed to be aimed at reducing or maintaining weight loss in persons with a body mass index (BMI) ≥ 25 kg/m(2) and have a technology aspect. Cochrane Collaborations tool for assessing risk of bias was used for rating the methodological quality. Twenty-seven trials met inclusion criteria. Thirteen studies showed significant effects on weight loss compared to controls. Most interventions used a web-based approach (42%). Interventions were screened for five technical key components: self-monitoring, counsellor feedback and communication, group support, use of a structured program and use of an individually tailored program. All interventions that used a combination of all five or four components showed significant decreases in weight compared to controls. No significant results for quality of life were found. Outcomes on program adherence were reported in six studies. No significant results were found between weight loss and program adherence. Evidence is lacking about the optimal use of technology in weight loss interventions. However, when the optimal combination of technological components is found, technology-based interventions may be a valid tool for weight loss. Furthermore, more outcomes on quality of life and information about the effect of technology-based intervention after bariatric surgery are needed.

Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair

Postoperative pain is an important adverse event following inguinal hernia repair. The aim of this trial was to compare postoperative pain within the first 3 months and 1 year after surgery in patients undergoing open mesh inguinal hernia repair using either a self‐gripping lightweight polyester mesh or a polypropylene lightweight mesh fixed with sutures.

An overview of the features influencing pain after inguinal hernia repair

Pain is a prominent issue in inguinal hernia repair research as its persisting appearance is a severe complication. The interest is also urged by the combination of a high number of repairs with an estimated risk for chronic postoperative pain of 11%. Almost every healthcare provider could encounter this complication. Pain is a complex study subject, mostly defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Various explanatory factors for pain following hernia repair have been reported. Most investigators, however, discuss only a few aspects. In the present review, these factors are collected to provide a more holistic synopsis of pain following hernia repair. It may be a resource for understanding this and other postsurgical pain.