Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06214988 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Study acronym: SELSA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06214988
Lead Sponsor Skane University Hospital
Collaborators: Umeå University, Lund University, Göteborg University, Ersta Hospital, Sweden, Copenhagen University Hospital at Herlev, Linkoeping University, Oslo University Hospital, Örebro University, Sweden
Conditions
(from sponsor)		 Rectal Cancer
Related terms Rectal Neoplasms
Enrollment 212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov