Selective use of stoma in rectal cancer surgery
SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
This study is testing whether a careful approach to using temporary stomas during rectal cancer surgery can help patients avoid complications and live without permanent stomas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Skane University Hospital Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Malmö) |
| Trial ID | NCT06214988 on ClinicalTrials.gov |
What this trial studies
This observational trial investigates a selective approach to using defunctioning stomas in patients undergoing low anterior resection for rectal cancer. It aims to determine if this selective strategy can reduce adverse outcomes such as bowel dysfunction and the need for permanent stomas while maintaining safety. The study includes a nested randomized controlled trial where eligible patients are assigned to either receive a defunctioning stoma or not, with outcomes measured over two years. Key outcomes include stoma-free survival and rates of complications like anastomotic leakage and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults under 80 years old with rectal cancer planned for low anterior resection and a low risk of anastomotic leakage.
Not a fit: Patients with emergency rectal resections or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life and fewer complications for rectal cancer patients undergoing surgery.
How similar studies have performed: Previous studies have shown that systematic use of defunctioning stomas can reduce complications, but this selective approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Malmö
- Skåne University Hospital — Malmö, Sweden (Recruiting)
Study contacts
- Principal investigator: Pamela Buchwald, MD PhD — Skåne University Hospital, Lund University
- Study coordinator: Caroline Nilsson, RN
- Email: caroline.n.nilsson@skane.se
- Phone: 004640331000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.