Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
About this study
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.
- Condition
- Rectal Cancer
- Tested
- selective approach defunctioning stoma
- Sponsor
- Skane University Hospital
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Study condition: Rectal Cancer
- 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 18
- 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
1 site, 1 recruiting
Skåne University Hospital
Malmö, Sweden
Contact
-
Caroline Nilsson, RN
004640331000 caroline.n.nilsson@skane.se
Potential match only. Final eligibility is determined by the study team.