Establishing core outcome sets for gastrointestinal recovery in studies of postoperative ileus and small bowel obstruction: protocol for a nested methodological study

Introduction Gastrointestinal recovery describes the restoration of normal bowel function in patients with bowel disease. This may be prolonged in two common clinical settings: postoperative ileus and small bowel obstruction. Improving gastrointestinal recovery is a research priority but researchers are limited by variation in outcome reporting across clinical studies. This protocol describes the development of core outcome sets for gastrointestinal recovery in the contexts of postoperative ileus and small bowel obstruction. Method An international Steering Group consisting of patient and clinician representatives has been established. As overlap between clinical contexts is anticipated, both outcome sets will be co‐developed and may be combined to form a common output with disease‐specific domains. The development process will comprise three phases, including definition of outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal‐group stakeholder discussions; online‐facilitated Delphi surveys via international networks; and a consensus meeting to ratify the final output. A nested study will explore if the development of overlapping outcome sets can be rationalized. Dissemination and implementation The final output will be registered with the Core Outcome Measures in Effectiveness Trials initiative. A multi‐faceted, quality improvement campaign for the reporting of gastrointestinal recovery in clinical studies will be launched, targeting international professional and patient groups, charitable organizations and editorial committees. Success will be explored via an updated systematic review of outcomes 5 years after registration of the core outcome set

Core outcome set for clinical studies of postoperative ileus after intestinal surgery

Postoperative ileus is a common and distressing complication after intestinal surgery. . It presents clinically as impairment of intestinal motility, characterized by abdominal pain, vomiting, and delayed recovery of defaecatory function. For patients, this increases the risk of serious complications, such as pneumonia, venous thromboembolic events, and malnutrition . For healthcare systems, it leads to a substantial economic burden associated with increased medical, nursing, dietitian, and laboratory costs . Accordingly, postoperative ileus is now recognized as a research priority by expert and public stakeholder groups . Numerous clinical interventions have been evaluated in efforts to prevent postoperative ileus, but few have led to meaningful patient benefit . A key challenge for researchers is the absence of a standardized and agreed framework to describe the effectiveness of new interventions in clinical studies . Common outcomes include the time taken until first passage of flatus/stool, time until tolerance of oral diet, and the return of bowel sounds. It remains unclear, however, whether these are sufficiently relevant to patients and healthcare professionals when evaluating new treatments and implementing them in clinical practice . A solution to this problem is the development of an agreed core outcome set developed through patient–clinician consensus. Core outcome sets provide a minimum set of outcomes that should be reported in all studies of a defined clinical condition and are supported by the Core Outcome Measures in Effective Trials (COMET) Initiative . The present report describes the international development and final content of an agreed core outcome set for postoperative ileus relevant to patients undergoing intestinal surgery.S.J. Chapman ... H. Kroon ... T. Sammour ... J. Han ... Tripartite Gastrointestinal Recovery Post-operative IIeus Group ... et al

Laparoscopic reintervention in colorectal surgery.

Item does not contain fulltextLaparoscopic colorectal surgery has developed in the 1990's and beginning of 2000. The favourable results and great progress in the development of laparoscopic techniques have expanded the indications of laparoscopic colorectal surgery. More and more complicated colorectal cases are treated laparoscopically, including those having had previous laparotomies. Surgical reinterventions after colorectal procedures are common. Reinterventions are either intended to treat complications of colorectal surgery or to treat colorectal disease after previous abdominal or pelvic surgery. Laparoscopic reinterventions face surgeons with specific challenges related to morphological changes in the abdomen. Adhesions are primarily responsible for these changes and evoke various complications such as trocar injury, bleeding, enterotomy and conversion to laparotomy. Trocars and Veress needle are responsible for up to half of all bowel injuries in laparoscopic surgery and adhesion formation is the most important risk factor for bowel injury. The risks of adhesions are often underestimated. The first clinical results on laparoscopic reinterventions are promising. Routine use of anti-adhesion agents and diagnostics is advocated to prevent adhesion formation and make reintervention more safe reducing serious complications as inadvertent enterotomy, bleeding and trocar injuries. More research is needed to develop better tools for mapping adhesions, as none of the trocar placing techniques can rule out bowel injury. Improved diagnostic tools for mapping adhesions will also facilitate patient selection for laparoscopic treatment of SBO

Adhesions: if the patient could only be their own control: left eye versus right eye, etc.

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Adhesion barriers for abdominal surgery and oncology - Authors' reply

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An Inconvenient Truth Regarding Operative Emergencies in General Surgery

Contains fulltext : 175683.pdf (publisher's version ) (Closed access

Efficacy and safety of the C-Qur Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial

Contains fulltext : 137909.pdf (publisher's version ) (Open Access)BACKGROUND: Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur Film to decrease the incidence of adhesions after colorectal surgery. METHODS/DESIGN: This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur Film) or control arm (no adhesion barrier). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, alpha = 0.05, 80% power). DISCUSSION: Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013

Preoperative nomogram to predict risk of bowel injury during adhesiolysis

BACKGROUND: Inadvertent bowel injury during adhesiolysis is a major cause of increased morbidity and mortality following abdominal surgery. Identification of risk factors predicting this complication would guide preoperative counselling and surgical decision-making. The aim of this study was to identify predictive preoperative factors for inadvertent bowel injury occurring during adhesiolysis. METHODS: All patients undergoing elective abdominal surgery between June 2008 and June 2010 were evaluated prospectively as part of the LAPAD study. Data on adhesiolysis and inadvertent organ injury were gathered by direct observation during operation. Univariable logistic regression was used to investigate factors that increased the risk of inadvertent bowel injury. Independent predictors of bowel injury were identified using multivariable logistic regression and used to create a clinical nomogram. RESULTS: Of 715 patients eligible for analysis, 48 (6.7 per cent) had inadvertent bowel injuries. In 42 patients the defect was detected during operation and in nine at a later time (3 patients had both). Bowel resection was required for almost two-thirds of the enterotomies. The number of previous laparotomies, anatomical site of the operation, presence of bowel fistula and laparotomy via a pre-existing median scar were independent predictors of bowel injury. A clinical scoring system was constructed using a nomogram incorporating these risk factors; this had a predictive discrimination, measured as the area under the receiver operating characteristic curve, of 0.85. CONCLUSION: A nomogram based on four independent factors predicted the risk of inadvertent bowel injury. Registration number: NCT01236625 (http://www.clinicaltrials.gov)

Obesity and Metabolic Syndrome, Too Big of an Enemy to Be Just Fought with a Scalpel

Contains fulltext : 217384.pdf (Publisher’s version ) (Open Access

Health-related quality of life and hospital costs following esophageal resection: a prospective cohort study

Contains fulltext : 152957.pdf (publisher's version ) (Open Access)BACKGROUND: The incidence rates for adenocarcinoma of the esophagus are increasing while the prognosis has only improved slightly. There is no apparent benefit in short- and long-term survival after different surgical strategies, but surgery is associated with significant morbidity. The goal of this study is to prospectively assess the quality of life and hospital costs after esophageal resections depending on the development of complications. METHODS: Prospective data was collected from 47 patients undergoing an esophageal resection for esophageal cancer participating in the prospective LAParotomy or LAParoscopy and Adhesions (LAPAD) study (clinicaltrials.gov registration number: NCT01236625). A comparison was made between patients who developed major complications and minor or no complications regarding quality of life and hospital costs. RESULTS: Thirteen patients developed major complications while 34 patients developed only minor or no complications. Patients with major complications had a mean hospital cost of $16,369 vs$12,409 for patients without or with minor complications. We found no difference in quality of life between the two groups 6 months after surgery. CONCLUSIONS: In our cohort, major complications did not seem to have a detrimental effect on postoperative quality of life 6 months after surgery but they increased costs associated with esophageal resection