NCT06214988 Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
| NCT ID | NCT06214988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Skane University Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 212 participants in total. It began in 2024-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Pamela Buchwald, MD PhD
PRINCIPAL INVESTIGATOR
Skåne University Hospital, Lund University
Frequently Asked Questions
Who can join the NCT06214988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06214988 currently recruiting?
Yes, NCT06214988 is actively recruiting participants. Contact the research team at caroline.n.nilsson@skane.se for enrollment information.
Where is the NCT06214988 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT06214988 clinical trial?
NCT06214988 is sponsored by Skane University Hospital. The principal investigator is Pamela Buchwald, MD PhD at Skåne University Hospital, Lund University. The trial plans to enroll 212 participants.
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