Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

NCT06214988 | Recruiting DMC

• 1 other identifier: 2023-0437-01
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

anterior resection; defunctioning stoma; selective approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Anastomotic leakage

  1,3,12 and 24 months

• Complications

  1,3,12 and 24 months

• Length of hospital stay

  until discharge within 90 days

• Postoperative mortality

  3 months

• Major Low Anterior Resection Syndrome

  12 and 24 months

Study Arms (2)

selective approach to defunctioning stoma

EXPERIMENTAL

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

Procedure: selective approach defunctioning stoma

routine use of defunctioning stoma

NO INTERVENTION

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.

Interventions

selective approach defunctioning stoma PROCEDURE

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

selective approach to defunctioning stoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Anastomotic leak risk score of 0-1
• Willingness to be randomised

You may not qualify if:

• 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)

Sponsors & Collaborators

• Skane University Hospital: lead
• Umeå University: collaborator
• Lund University: collaborator
• Göteborg University: collaborator
• Ersta Hospital, Sweden: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Linkoeping University: collaborator
• Oslo University Hospital: collaborator
• Örebro University, Sweden: collaborator

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 39887540 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pamela Buchwald, MD PhD

  Skåne University Hospital, Lund University

  PRINCIPAL INVESTIGATOR

• Martin Rutegård, MD PhD

  Umeå University Hospital, Umeå University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Nilsson, RN

CONTACT

004640331000; caroline.n.nilsson@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, senior consultant surgeon

Model Details: Observational trial with nested randomized trial

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 22, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When study complete including primary and secondary endpoints.

Locations

SE (1)