Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer (SELSA)

SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial

The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. The primary outcome is a hybrid so-called textbook outcome; stoma-free survival at two years without major LARS, reflecting a functionally appropriate outcome after low anterior resection for rectal cancer. Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: selective approach defunctioning stoma

Detailed Description

Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions. However, accumulating data suggest that this comes at the price of worse bowel dysfunction, a higher rate of permanent stomas and kidney injury. We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences, while still being safe for patients.

This is a multicentre international prospective trial including a non-blinded randomised clinical trial. All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible. Patients enter a prospective observational study, in which a randomised clinical trial is nested. Patients eligible for randomisation are aged below 80 years, have an American Society of Anesthesiologists' fitness grade I or II, have no unresected distant disease, and have a predicted lower risk of anastomotic leakage. Patients will be randomised 1:1 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma. The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use. The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients.

This study has been approved by Ethical Review Authority in Sweden (2023-04347-01) and seeks permission in Norway and Danmark, respectively. The results will be disseminated through patient associations, popular science, the broader medical community, and conventional scientific channels.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Nilsson, RN; Phone Number: 004640331000; Email: caroline.n.nilsson@skane.se

Study Locations

• Sweden
  • Malmö, Sweden
    • Recruiting
    • Skane University Hospital
    • Contact: Pamela Buchwald, MD PhD; Email: pamela.buchwald@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach

Additional inclusion criteria for randomised part of the study:

• Patients aged less than 80 years
• Patients with American Society of Anesthetists' (ASA) fitness grade I or II as determined by the anaesthesiologist or the surgeon
• Patients without clear radiological signs of distant disease before rectal cancer surgery (previous metastatic surgery is no exclusion criterion)
• Anastomotic leak risk score of 0-1
• Willingness to be randomised

Exclusion Criteria:

• Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent
• Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc)
• Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study
• Previous pelvic irradiation (due to e.g. gynaecological or urological cancer)
• Preoperative tumour perforation or pelvic sepsis
• Beyond TME surgery and/or concurrent resection of other organ
• Concurrent corticosteroid treatment (prednisone-equivalent dosage ≥10 mg daily)
• Planned postoperative chemotherapy
• Smoking not completely ceased four weeks before surgery

• Excessive alcohol consumption with social and medical consequences (as judged by the surgeon in charge) Intraoperative exclusion criteria for randomised part of the study

  ->2 staple firings for rectal transection

• Intraoperative blood loss ≥250 ml for minimally invasive surgery
• Intraoperative blood loss ≥500 ml for open or converted surgery
• More than one intraabdominal anastomosis performed
• Incomplete doughnuts
• Air-leak test positive
• Any significant intraoperative adverse event at the discretion of the operating surgeon (e.g. ureterotomy, bowel or tumour perforation, major medical event - pulmonary embolism, cardiac arrhythmia) (Gawria, 2022)
• TME with anastomosis ultimately not done

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: selective approach to defunctioning stoma; With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.	Procedure: selective approach defunctioning stoma; With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.
No Intervention: routine use of defunctioning stoma; With randomisation to this control arm (systematic approach), a defunctioning stoma is constructed using the marked stoma site. A loop ileostomy is fashioned using an ileal loop close to the ileocecal valve, while a loop colostomy can be derived from either the transverse or a redundant left colon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
textbook outcome; stoma-free survival at two years without major LARS	extant stoma, alive, and a LARS score at 30 or lesn has stabilised as well for those without a stoma in situ. no extant stoma, alive, and a LARS score at 30 or less at the time point two years after the anterior resection.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leakage	ISREC grading	1,3,12 and 24 months
Complications	Clavien-Dinco	1,3,12 and 24 months
Length of hospital stay	total days in hospital	until discharge within 90 days
Postoperative mortality	death	3 months
Major Low Anterior Resection Syndrome	domain score scale 0-42 points, >30 points indicate a bad functional outcome i.e. major LARS	12 and 24 months
Quality of life by European Organization for Research and Treatment of Cancer- ColoRectal 29 (EORTC-CR29)	EORTC-CR29 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	12 and 24 months
Quality of Recovery-15 Swedish (QoR15swe)	Difference from baseline in total score 0-150 points, higher value indicating faster recovery	1 month
Adjuvant chemotherapy for high-risk patients	Clinical assessment categorisation	12 months
Renal function	Creatinine (mg/L)	12 and 24 months
Stay out of hospital	total days of alive and out of hospital	24 months
Stoma in situ	proportion	24 months
Recurrence (local and distant)	Clinical assessment categorisation	36 and 60 months
Overall survival	Clinical assessment categorisation	36 and 60 months
Quality of life by European Organization for Research and Treatment of Cancer- Cancer30 (EORTC-C30)	EORTC-C30 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	12 and 24 months

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Collaborators: Lund University; Oslo University Hospital; Göteborg University; Umeå University; Linkoeping University; Copenhagen University Hospital at Herlev; Örebro University, Sweden; Ersta Hospital, Sweden
• Investigators: Principal Investigator: Pamela Buchwald, MD PhD, Skane University Hospital, Lund University; Principal Investigator: Martin Rutegård, MD PhD, Umeå University Hospital, Umeå University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: anterior resection; defunctioning stoma; selective approach
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 2023-0437-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unidentified raw data may be shared upon request.
• IPD Sharing Time Frame: When study complete including primary and secondary endpoints.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No