Dataset Information

Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Anastomotic leakage is the most important complication in colorectal surgery occurring in up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy is usually created during low anterior resection to protect the anastomosis or rather to diminish the consequences in case of anastomotic leakage. The so-called virtual or ghost ileostomy is a pre-stage ostomy that can be easily exteriorised, if anastomotic leakage is suspected, in order to avoid the severe consequences of anastomotic leakage. On the other hand, an actual ileostomy can be avoided in patients, who do not develop anastomotic leakage. METHODS AND ANALYSIS:The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer. After screening for eligibility and obtaining informed consent, a total of 60 adult patients are included in the trial. Patients are intraoperatively randomised to the trial groups in a 1:1 ratio after assuring that none of the intraoperative exclusion criteria are present. The main outcome parameter is the comprehensive complication index as a measure of safety. Further outcomes include specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Follow-up for each individual patient will be 6 months. ETHICS AND DISSEMINATION:The GHOST trial has been approved by the Medical Ethics Committee of Heidelberg University (reference number S-694/2017). If the intervention proves to be safe, loop ileostomy could be spared in a large proportion of patients, thus also avoiding stoma-related complications and a second operation (ileostomy closure) with its inherent complications in these patients. TRIAL REGISTRATION NUMBER:German Clinical Trials Registry (DRKS00013997); Universal Trial Number: U1111-1208-9742.

SUBMITTER: Huttner FJ

PROVIDER: S-EPMC7566726 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.

Hüttner Felix J FJ Probst Pascal P Mihaljevic André A Contin Pietro P Dörr-Harim Colette C Ulrich Alexis A Schneider Martin M Büchler Markus W MW Diener Markus K MK Knebel Phillip P

BMJ open 20201015 10

<h4>Introduction</h4>Anastomotic leakage is the most important complication in colorectal surgery occurring in up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy is usually created during low anterior resection to protect the anastomosis or rather to diminish the consequences in case of anastomotic leakage. The so-called virtual or ghost ileostomy is a pre-stage ostomy that can be easily exteriorised, if anastomotic leakage is suspected, in order to avoid the severe ...[more]

PMID: 33060088

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Project description:INTRODUCTION:A defunctioning ileostomy is often formed during rectal cancer surgery to reduce the potentially fatal sequelae of anastomotic leak. Once the ileostomy is closed and bowel continuity restored, many patients can suffer poor bowel function, that is, low anterior resection syndrome (LARS). It has been suggested that delay to closure can increase incidence of LARS which is known to significantly reduce quality of life. Despite this, within the UK, time to closure of ileostomy is not subject to national targets within the National Health Service and delay to closure exceeds 18 months in one-third of patients. Clinical factors, surgeon and patient preference or service pressures may all impact time to closure, yet to date no study has investigated this. The aim of this UK-wide study is to assess time to ileostomy closure and identify reasons for delays. METHODS AND ANALYSIS:A UK-wide multicentre prospective snapshot study, together with retrospective analysis of ileostomy closure through The Dukes' Club Research Collaborative including patients undergoing ileostomy closure in a 3-month period (April to June 2018) and all patients who underwent anterior resection and ileostomy formation over a historical 12-month period (2015). Time to closure and incidence of 'non-closure' will be calculated. Units will be surveyed to determine local clinical and management protocols and barriers to timely closure. Multivariate linear regression analysis will be used to determine factors significantly associated with delay to ileostomy closure. ETHICS AND DISSEMINATION:Study approved by the South West-Exeter Research Ethics Committee and the Health Research Authority. Study results will be submitted for presentation at international conferences and for publication in peer-reviewed journals. Results will be presented to and discussed with the patient and public representatives and relevant national bodies to facilitate the development of consensus guidelines on optimum treatment pathways.

Project description:BackgroundPreserving the left colic artery (LCA) during anterior resection for rectal cancer is controversial, and robust evidence of the outcomes of LCA preservation plus apical lymph node dissection is lacking. The purpose of this study was to investigate the impact of LCA preservation plus apical lymph node dissection surgery on anastomotic leakage and number of harvested lymph nodes.MethodsPatients who underwent laparoscopic or robotic anterior resection for rectal cancer between September 2017 and May 2020 were retrospectively assessed. The patients were categorized into two groups: preservation of LCA and nonpreservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was anastomotic leakage within 30 days after surgery. The secondary outcomes were number of harvested lymph nodes, 3-year overall survival, and 3-year disease-free survival.ResultsA total of 216 patients were eligible for this study, and propensity score matching yielded 60 patients in each group. Anastomotic leakage in the LCA preservation group was significantly lower than that in the LCA nonpreservation group (3.3% vs. 13.3%, P = 0.048). No significant differences were observed in blood loss, operation time, intraoperative complications, splenic flexure mobilization, total number of harvested lymph nodes, number of positive lymph nodes, time to first flatus, or postoperative hospital stay. Kaplan-Meier survival analysis showed a 3-year disease-free survival of 85.7% vs. 80.5% (P = 0.738) and overall survival of 92.4% vs. 93.7% (P = 0.323) for the preservation and nonpreservation groups, respectively.ConclusionLCA preservation plus apical lymph node dissection surgery for rectal cancer may help reduce the incidence of anastomotic leakage without impairing the number of harvested lymph nodes. Preliminary results suggest that 3-year disease-free survival and overall survival rates may not differ between the two types of surgery, but studies with larger sample sizes are needed to confirm these conclusions. Trial registration ClinicalTrials.gov, NCT03776370. Registered 14 December 2018-Retrospectively registered, https://clinicaltrials.gov .

Dataset Information

Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.

Publications

Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.

Similar Datasets

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