Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Launched by SKANE UNIVERSITY HOSPITAL · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a specific approach to managing patients with rectal cancer who are undergoing a surgical procedure called low anterior resection. The goal is to determine whether using a temporary stoma (an opening created to divert waste) can improve outcomes for patients, particularly in terms of living without complications for at least two years after surgery. The study will look at various factors, including the risk of leakage from the surgical connection, recovery rates, quality of life, and the need for any additional surgeries or complications related to the stoma.

To be eligible for this trial, participants need to be adults planning to have low anterior resection surgery for rectal cancer, ideally under the age of 80, and in good health as evaluated by their doctors. Those who do not speak Swedish, Norwegian, Danish, or English well enough to understand the study information are excluded, as are patients with certain medical conditions or those who have had specific previous treatments. If you decide to join the trial, you will be closely monitored for two years to track your recovery and any issues related to the surgery and the stoma. This study aims to help improve surgical outcomes and quality of life for future patients with rectal cancer.

Gender

ALL

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