Stoma Colostomy, Stoma Ileostomy
Conditions
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)).
Interventions
PROCEDURELoop ileostomy
Patient undergoing anterior rectal resection will receive loop ileostomy
PROCEDURELoop colostomy
Patient undergoing anterior rectal resection will receive loop colostomy
Sponsors
Helsinki University Central Hospital
Mary and Georg Ehrnrooth's foundation
Helsinki University Hospital Research Funds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stoma-related adverse events | Within 60 days from randomization | Stoma-related adverse events score by using Comprehensive Complication Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Finland
Contacts
CONTACTLaura Koskenvuo, MD, PhD
CONTACTVille Sallinen, MD, PhD
PRINCIPAL_INVESTIGATORVille Sallinen, MD, PhD
Helsinki University Central Hospital
Outcome results
None listed