Comparison of Loop Ileostomy and Loop Colostomy as Protective Stomas After Anterior Rectal Resection for Rectal Tumors
Led by Helsinki University Central Hospital · Updated on 2026-06-09
350
Participants Needed
3
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing two types of protective stomas, loop ileostomy and loop colostomy, used after anterior rectal resection surgery for patients with rectal tumors. This multicenter, open-label, randomized study aims to find out which type is better at reducing stoma-related complications within 60 days after surgery. The study focuses on patients undergoing anterior rectal resection with primary anastomosis who are planned to have a protective stoma.
Participants are randomly assigned during surgery to receive either a loop ileostomy or a loop colostomy. Both procedures are performed as part of the anterior rectal resection surgery. The main comparison is based on complications related to the stoma within 60 days after the initial surgery.
During the study, participants will be monitored for stoma-related adverse events and other postoperative complications within 30 days after surgery and after stoma closure. Researchers will also assess hospital-free days, quality of life at 2 months, and kidney function changes within 1 year. The total participation duration extends up to the completion of stoma closure and follow-up assessments, with primary outcome measurement within 60 days post-surgery.
CONDITIONS
Brief Title
Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
Research Team
L
Laura Koskenvuo, MD, PhD
V
Ville Sallinen, MD, PhD
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Patients undergoing anterior resection surgery for rectal tumor with planned protective stoma
You will not qualify if you...
Already having a stoma or another stoma made during surgery
Unable to create ileostomy or colostomy due to prior bowel surgery or anatomical factors
Under 18 years of age
Inadequate ability to cooperate during the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single surgical procedure
Participants undergo anterior rectal resection surgery and receive either a loop ileostomy or loop colostomy as a protective stoma.
Randomization occurs during surgery
Follow-up
Duration - Up to 1 year
Participants are monitored for stoma-related adverse events and other postoperative complications up to 60 days after surgery, with additional assessments after stoma closure and up to 1 year for kidney function.
Regular follow-up visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
PROtective ileoStomy versus ProtectivE colostomy in anterior Rectal resectIon: study protocol for a multicenter, open-label, randomised conTrolled studY (PROSPERITY).