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Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkane University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach

Patients aged less than 80 years

Patients with American Society of Anesthetists' (ASA) fitness grade I or II as determined by the anaesthesiologist or the surgeon

Patients without clear radiological signs of distant disease before rectal cancer surgery (previous metastatic surgery is no exclusion criterion)

Disqualifiers

Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent

Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc)

Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study

Previous pelvic irradiation (due to e.g. gynaecological or urological cancer)

Trial design

Design model

Parallel

Treatments tested in this trial

  • selective approach defunctioning stoma

    Procedure/Surgery

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

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: selective approach to defunctioning stomaExperimental treatment 1 intervention
Group B: routine use of defunctioning stomaNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

textbook outcome; stoma-free survival at two years without major LARS

extant stoma, alive, and a LARS score at 30 or lesn has stabilised as well for those without a stoma in situ. no extant stoma, alive, and a LARS score at 30 or less at the time point two years after the anterior resection.

Time frame
2 year

Secondary outcomes

1

Anastomotic leakage

ISREC grading

Time frame
1,3,12 and 24 months
2

Complications

Clavien-Dinco

Time frame
1,3,12 and 24 months
3

Length of hospital stay

total days in hospital

Time frame
until discharge within 90 days
4

Postoperative mortality

death

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Skane University Hospital

Lead sponsor

Umeå University

Collaborator

Lund University

Collaborator

Göteborg University

Collaborator

Ersta Hospital, Sweden

Collaborator

Copenhagen University Hospital at Herlev

Collaborator

Linkoeping University

Collaborator

Oslo University Hospital

Collaborator

Örebro University, Sweden

Collaborator

Source ClinicalTrials.gov
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