A Decalogue to Avoid Routine Ileostomy in Selected Patients With Border Line Risk to Develop Anastomotic Leakage After Minimally Invasive Low-Anterior Resection: A Pilot Study

Purpose. Protective ileostomy (PI) during anterior resection (AR) for rectal cancer decreases the incidence of anastomotic leakage (AL) and its subsequent complications, but it may itself be the cause of morbidity. The aim is to report our protocol in the management of selected patients with borderline risk to develop AL after laparoscopic AR and ghost ileostomy (GI) creation. Methods. Patients who underwent AR were stratified based on the risk to develop AL. Steps to avoid PI were splenic flexure mobilization, reduced pelvic bleeding, to employ different stapler charge if neoadjuvant chemo-radiotherapy is performed, to perform a horizontal section of the rectum, to evaluate the anastomotic vascularization with a fluorescence angiography, to perform a side-to-end anastomosis, intraoperative methylene blue test, pelvic and transanal drainage tubes placement, and the GI creation. After surgery, inflammatory blood markers were monitored to detect potential leakages. Results. Twelve patients were included. In one case, the specimen proximal section was changed after fluorescence angiography. There were no conversions in this group of patients. One postoperative AL occurred and was treated with radiological drainage placement, not being necessary to convert the GI. PI was avoided in 100% of cases. Conclusions. Patients’ characteristics cannot be changed, but several steps were used to avoid routine PI creation. The present protocol could be a valuable option to avoid PI in selected patients. Further studies with a wider sample size, and defined criteria to stratify the patients based on the risk to develop AL, are required.

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IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol

BMC Surgery ◽

10.1186/s12893-020-00890-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

M. D. Slooter ◽

◽

K. Talboom ◽

S. Sharabiany ◽

C. P. M. van Helsdingen ◽

...

Keyword(s):

Rectal Cancer ◽

Early Detection ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Active Management ◽

Fluorescence Angiography ◽

Early Management ◽

One Year

Abstract Background Anastomotic leakage (AL) is still a common and feared complication after low anterior resection (LAR) for rectal cancer. The multifactorial pathophysiology of AL and lack of standardised treatment options requires a multi-modal approach to improve long-term anastomotic integrity. The objective of the IMARI-trial is to determine whether the one-year anastomotic integrity rate in patients undergoing LAR for rectal cancer can be improved using a multi-interventional program. Methods IMARI is a multicentre prospective clinical effectiveness trial, whereby current local practice (control cohort) will be evaluated, and subsequently compared to results after implementation of the multi-interventional program (intervention cohort). Patients undergoing LAR for rectal cancer will be included. The multi-interventional program includes three preventive interventions (mechanical bowel preparation with oral antibiotics, tailored full splenic flexure mobilization and intraoperative fluorescence angiography using indocyanine green) combined with a standardised pathway for early detection and active management of AL. The primary outcome is anastomotic integrity, confirmed by CT-scan at one year postoperatively. Secondary outcomes include incidence of AL, protocol compliance and association with AL, temporary and permanent stoma rate, reintervention rate, quality of life and functional outcome. Microbiome analysis will be conducted to investigate the role of the rectal microbiome in AL. In a Dutch nationwide study, the AL rate was 20%, with anastomotic integrity of 90% after one year. Based on an expected reduction of AL due to the preventive approaches of 50%, and increase of anastomotic integrity by a standardised pathway for early detection and active management of AL, we hypothesised that the anastomotic integrity rate will increase from 90 to 97% at one year. An improvement of 7% in anastomotic integrity at one year was considered clinically relevant. A total number of 488 patients (244 per cohort) are needed to detect this difference, with 80% statistical power. Discussion The IMARI-trial is designed to evaluate whether a multi-interventional program can improve long-term anastomotic integrity after rectal cancer surgery. The uniqueness of IMARI lies in the multi-modal design that addresses the multifactorial pathophysiology for prevention, and a standardised pathway for early detection and active treatment of AL. Trial registration Trialregister.nl (NL8261), January 2020.

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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

BMJ Open ◽

10.1136/bmjopen-2020-038930 ◽

2020 ◽

Vol 10 (10) ◽

pp. e038930

Author(s):

Felix J Hüttner ◽

Pascal Probst ◽

André Mihaljevic ◽

Pietro Contin ◽

Colette Dörr-Harim ◽

...

Keyword(s):

Rectal Cancer ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Loop Ileostomy ◽

Pilot Trial ◽

Ileostomy Closure ◽

Ghost Ileostomy ◽

Anterior Rectal Resection ◽

Randomised Controlled

IntroductionAnastomotic 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 analysisThe 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 disseminationThe 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 numberGerman Clinical Trials Registry (DRKS00013997); Universal Trial Number: U1111-1208-9742.

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