Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

Not Applicable

Not yet recruiting

• Conditions: Stoma Colostomy; Stoma Ileostomy

• Registration Number: NCT06650085
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Primary Completion: 2027-10
• Study Completion: 2032-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.

The exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age <18 years, (4) inadequate ability to co-operate.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stoma-related adverse events	Within 60 days from randomization	Stoma-related adverse events score by using Comprehensive Complication Index

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Within 30 days from randomization	All complications scored using Comprehensive Complication Index
Postoperative complications after stoma closure	Within 30 days from stoma closure	All complications after stoma closure using Comprehensive Complication Index (including only patients who have undergone stoma closure within 1 year from primary surgery)
Hospital-free days	Within 30 days from randomization	Days patient is alive and out of any hospital
Quality of life	At 2 months from randomization	Quality of life measured using EORTC Quality of life questionnaires core 30 with colorectal 29 extension (QLQ-C30+QLQ-CR29)
Kidney function change	Within 1 year from randomization	Kidney function change defined as difference in eGFR before and 1 year after randomization

Trial Locations

Locations (3)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland