Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

NCT ID: NCT06214988

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2030-12-31

Brief Summary

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.

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

selective approach to defunctioning stoma

With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.

Group Type: EXPERIMENTAL

selective approach defunctioning stoma

Intervention Type: PROCEDURE

With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

selective approach defunctioning stoma

With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• 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)
• 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

->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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Ersta Hospital, Sweden

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pamela Buchwald

associate professor, senior consultant surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Buchwald, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Skåne University Hospital, Lund University

Martin Rutegård, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University Hospital, Umeå University Hospital

Locations

Skåne University Hospital

Malmo, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Caroline Nilsson, RN

Role: CONTACT

caroline.n.nilsson@skane.se

004640331000

Facility Contacts

Pamela Buchwald, MD PhD

Role: primary

pamela.buchwald@med.lu.se

References

Rutegard M, Lindskold M, Jorgren F, Landerholm K, Matthiessen P, Forsmo HM, Park J, Rosenberg J, Schultz J, Seeberg LT, Segelman J, Buchwald P. SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision. Colorectal Dis. 2025 Feb;27(2):e70009. doi: 10.1111/codi.70009.

Reference Type: DERIVED

PMID: 39887540 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-0437-01

Identifier Type: -

Identifier Source: org_study_id