Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Rectal Cancer Clinical Trial

— SELSA  

Official title:

SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214988
• Other study ID #: 2023-0437-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: Skane University Hospital
• Contact: Caroline Nilsson, RN
• Phone: 004640331000
• Email: caroline.n.nilsson[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions. However, accumulating data suggest that this comes at the price of worse bowel dysfunction, a higher rate of permanent stomas and kidney injury. We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences, while still being safe for patients.

This is a multicentre international prospective trial including a non-blinded randomised clinical trial. All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible. Patients enter a prospective observational study, in which a randomised clinical trial is nested. Patients eligible for randomisation are aged below 80 years, have an American Society of Anesthesiologists' fitness grade I or II, have no unresected distant disease, and have a predicted lower risk of anastomotic leakage. Patients will be randomised 1:1 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma. The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use. The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). 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. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients.

This study has been approved by Ethical Review Authority in Sweden (2023-04347-01) and seeks permission in Norway and Danmark, respectively. The results will be disseminated through patient associations, popular science, the broader medical community, and conventional scientific channels.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 212
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• selective approach defunctioning stoma
With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Skane University Hospital	Copenhagen University Hospital at Herlev, Ersta Hospital, Sweden, Göteborg University, Linkoeping University, Lund University, Örebro University, Sweden, Oslo University Hospital, Umeå University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	textbook outcome; stoma-free survival at two years without major LARS	extant stoma, alive, and a LARS score at 30 or lesn has stabilised as well for those without a stoma in situ.; no extant stoma, alive, and a LARS score at 30 or less at the time point two years after the anterior resection.	2 year
Secondary	Anastomotic leakage	ISREC grading	1,3,12 and 24 months
Secondary	Complications	Clavien-Dinco	1,3,12 and 24 months
Secondary	Length of hospital stay	total days in hospital	until discharge within 90 days
Secondary	Postoperative mortality	death	3 months
Secondary	Major Low Anterior Resection Syndrome	domain score scale 0-42 points, >30 points indicate a bad functional outcome i.e. major LARS	12 and 24 months
Secondary	Quality of life by European Organization for Research and Treatment of Cancer- ColoRectal 29 (EORTC-CR29)	EORTC-CR29 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	12 and 24 months
Secondary	Quality of Recovery-15 Swedish (QoR15swe)	Difference from baseline in total score 0-150 points, higher value indicating faster recovery	1 month
Secondary	Adjuvant chemotherapy for high-risk patients	Clinical assessment categorisation	12 months
Secondary	Renal function	Creatinine (mg/L)	12 and 24 months
Secondary	Stay out of hospital	total days of alive and out of hospital	24 months
Secondary	Stoma in situ	proportion	24 months
Secondary	Recurrence (local and distant)	Clinical assessment categorisation	36 and 60 months
Secondary	Overall survival	Clinical assessment categorisation	36 and 60 months
Secondary	Quality of life by European Organization for Research and Treatment of Cancer- Cancer30 (EORTC-C30)	EORTC-C30 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	12 and 24 months