Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital
About this trial
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)).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Loop ileostomy
Procedure/SurgeryPatient undergoing anterior rectal resection will receive loop ileostomy
Loop colostomy
Procedure/SurgeryPatient undergoing anterior rectal resection will receive loop colostomy
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Loop ileostomyExperimental treatment 1 intervention
Group B: Loop colostomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stoma-related adverse events
Stoma-related adverse events score by using Comprehensive Complication Index
Time frame
Within 60 days from randomizationSecondary outcomes
1
Postoperative complications
All complications scored using Comprehensive Complication Index
Time frame
Within 30 days from randomization2
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 closure3
Hospital-free days
Days patient is alive and out of any hospital
Time frame
Within 30 days from randomization4
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 randomizationOther outcomes
1
5-year overall survival
Number of patients alive within 5 years from randomization
Time frame
Within 5 years from randomization2
5-year disease-free survival
Number of patients alive and disease-free within 5 years from randomization (including only patients with M0 at primary operation undergoing radical R0/1 surgery)
Time frame
Within 5 years from randomization3
Kidney function change at 5 years
Kidney function change defined as difference in eGFR before and 5 years after randomization
Time frame
Within 5 years from randomization4
Incisional hernia
Number of incision hernias of ostomy site (only patients who have undergone successful stoma closure and alive at 5 years will be included in this analysis)
Time frame
Within 5 years from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helsinki University Central Hospital
Lead sponsor
Mary and Georg Ehrnrooth's foundation
Collaborator
Helsinki University Hospital Research Funds
Collaborator
Source ClinicalTrials.gov