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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Patient undergoing anterior rectal resection will receive loop ileostomy
Patient undergoing anterior rectal resection will receive loop colostomy
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Stoma-related adverse events
Stoma-related adverse events score by using Comprehensive Complication Index
Time frame: Within 60 days from randomization
Postoperative complications
All complications scored using Comprehensive Complication Index
Time frame: Within 30 days from randomization
Postoperative complications after 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)
Time frame: Within 30 days from stoma closure
Hospital-free days
Days patient is alive and out of any hospital
Time frame: Within 30 days from randomization
Quality of life
Quality of life measured using EORTC Quality of life questionnaires core 30 with colorectal 29 extension (QLQ-C30+QLQ-CR29)
Time frame: At 2 months from randomization
Kidney function change
Kidney function change defined as difference in eGFR before and 1 year after randomization
Time frame: Within 1 year from randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.