Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Summary

The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. The primary outcome is a hybrid so-called textbook outcome; stoma-free survival at two years without major LARS, reflecting a functionally appropriate outcome after low anterior resection for rectal cancer. Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery.

Conditions

• Rectal Cancer

Interventions

PROCEDURE

selective approach defunctioning stoma

With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.

Sponsors & Collaborators

• Umeå University

  collaborator OTHER

• Lund University

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Ersta Hospital, Sweden

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Oslo University Hospital

  collaborator OTHER

• Örebro University, Sweden

  collaborator OTHER

• Skane University Hospital

  lead OTHER

Principal Investigators

• Pamela Buchwald, MD PhD · Skåne University Hospital, Lund University

• Martin Rutegård, MD PhD · Umeå University Hospital, Umeå University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2027-12-31

Completion

2030-12-31

Countries

• Sweden

Study Locations