Clinical trial · Interventional
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| selective approach defunctioning stoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- selective approach to defunctioning stoma
- description
- With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.
- interventionNames
- Procedure: selective approach defunctioning stoma
- type
- NO_INTERVENTION
- label
- routine use of defunctioning stoma
- description
- With randomisation to this control arm (systematic approach), a defunctioning stoma is constructed using the marked stoma site. A loop ileostomy is fashioned using an ileal loop close to the ileocecal valve, while a loop colostomy can be derived from either the transverse or a redundant left colon.
Primary outcomes (1)
- measure
- textbook outcome; stoma-free survival at two years without major LARS
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach Additional inclusion criteria for randomised part of the study: * 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) * Anastomotic leak risk score of 0-1 * Willingness to be randomised Exclusion Criteria: * 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) * Preoperative tumour perforation or pelvic sepsis * Beyond TME surgery and/or concurrent resection of other organ * Concurrent corticosteroid treatment (prednisone-equivalent dosage ≥10 mg daily) * Planned postoperative chemotherapy * Smoking not completely ceased four weeks before surgery * Excessive alcohol consumption with social and medical consequences (as judged by the surgeon in charge) Intraoperative exclusion criteria for randomised part of the study -\>2 staple firings for rectal transection * Intraoperative blood loss ≥250 ml for minimally invasive surgery * Intraoperative blood loss ≥500 ml for open or converted surgery * More than one intraabdominal anastomosis performed * Incomplete doughnuts * Air-leak test positive * Any significant intraoperative adverse event at the discretion of the operating surgeon (e.g. ureterotomy, bowel or tumour perforation, major medical event - pulmonary embolism, cardiac arrhythmia) (Gawria, 2022) * TME with anastomosis ultimately not done
References
Publications (1)
- DERIVEDRutegard M, Lindskold M, Jorgren F, Landerholm K, Matthiessen P, Forsmo HM, Park J, Rosenberg J, Schultz J, Seeberg LT, Segelman J, Buchwald P. SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision. Colorectal Dis. 2025 Feb;27(2):e70009. doi: 10.1111/codi.70009. PMID 39887540