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Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

NCT06650085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-10-21

No results posted yet for this study

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)).

Conditions

  • Stoma Colostomy
  • Stoma Ileostomy

Interventions

PROCEDURE

Loop ileostomy

Patient undergoing anterior rectal resection will receive loop ileostomy

PROCEDURE

Loop colostomy

Patient undergoing anterior rectal resection will receive loop colostomy

Sponsors & Collaborators

  • Mary and Georg Ehrnrooth's foundation

    collaborator UNKNOWN

  • Helsinki University Hospital Research Funds

    collaborator UNKNOWN

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Ville Sallinen, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2027-10-31
Completion
2032-10-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650085 on ClinicalTrials.gov