Clinical trial NCT05027737: Early Ileostomy Closure for Rectal Cancer Patients in North America
Official title: Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ileostomy - Stoma
Rectal Cancer
Keywords: Early ileostomy closure
Comprehensive complication index
Bowel function
Quality of life
Recovery
Cost
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2021-08-30
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, assessor-blind, parallel-groups (1:1), pragmatic, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop ileostomy (DLI). The feedback from leaders in Europe further supports the need for a large scale randomized-controlled trial (RCT) on this subject in North America. Should the results of such a study be favourable, we believe it could support a change in practice that would be beneficial to patients and the health care system alike. Furthermore, our work will help identify which patients and practices are suitable for EIC.

The goal of our project is to determine whether EIC in rectal cancer patients undergoing RP with a DLI is safe, feasible and beneficial in a North American population. Specifically, our primary objective is to compare the severity of complications between patients undergoing EIC versus traditional (late) closure. Our secondary objectives include assessing the difference in quality of life (QoL), early and late bowel function, and cost of care between these two groups.

Detailed description: Eligible adults (≥18 years-old) from one a large colorectal surgery practice in Canada who (1) underwent RP with creation of a DLI for the treatment of rectal cancer and (2) have a negative anastomotic leak test on post-operative day 7-9 which will consist of a flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast. Patients will be excluded if there is (1) peri-operative immunosuppression, (2) age-adjusted Charlson Comorbidity Index \>6, (3) other major surgery during the index operation, and (4) any major complications (Clavien Dindo Grade III-V) following RP. Eligible participants will be randomized (1:1): Intervention group (EIC): Following a negative leak test, patients will undergo standardized reversal of their DLI (stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound and no use of epidural analgesia) between post-operative days 10-14. Control group (standard practice): Following a negative leak test, patients will undergo a standardized reversal of their DLI no earlier than 12 weeks following their index surgery.

The primary outcome will be comprehensive complication index (CCI) at 12 months following RP. Secondary outcomes will include: CCI at 2-, 6-, and 9-months following RP; recovery from surgery using the PROMIS 29 profile at 7- and 14-days post RP; bowel function, as measured using the Low Anterior Resection Syndrome (LARS) Score at 2-, 6-, 9-, and 12-months post-DLI closure; post-operative ileus, as defined by intolerance to oral intake in the absence of clinical or radiological signs of obstruction, will be measured prospectively after DLI closure; overall QoL, as measured by the EORTC CR30 and QLQ-CR38 at 0-, 2-, 6-, 9-, and 12-months post-RP; cost, as measured from the perspective of the healthcare system \[length of hospital stay (RP, ileostomy closure, and any readmissions), interventions in any setting following RP, and appliance-related costs\] will be assessed at 6- and 12-months post-index surgery. Treatment effect on the primary outcome (CCI at 12 months) will be modeled using linear regression.

Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years-old) patients
* Underwent restorative proctectomy by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with creation of a diverting loop ileostomy for the treatment of rectal cancer
* Negative anastomotic "leak test" via CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9.

Exclusion Criteria:

* Peri-operative immunosuppression (within 6 weeks of surgery date);
* Age-adjusted Charlson Comorbidity Index \>6;
* Other major surgery during the index operation;
* Any major complications (Clavien Dindo Grade III or greater) following restorative proctectomy;
* Inability to speak or comprehend English or French and inability to give informed consent.

Primary outcomes:
measure: Complications
timeFrame: 12-months post-restorative proctectomy
Secondary outcomes:
measure: Complications
timeFrame: 2-, 6-, and 9-months post-restorative proctectomy
measure: Occurrence of post-operative ileus following ileostomy reversal
timeFrame: Monitored for from date of ileostomy closure to day of discharge from hospital
measure: Cost of patient care (in dollars)
timeFrame: Calculated at 6- and 12-months post restorative proctectomy
measure: Time to chemotherapy (weeks)
timeFrame: Starting from restorative proctectomy post-operative day 1 through the course of the study (1 year follow-up)
measure: Post-operative recovery
timeFrame: 1- and 2-weeks post-restorative proctectomy and diverting loop ileostomy as well as 30 days post-diverting loop ileostomy closure
measure: Bowel function
timeFrame: 2-, 6-, 9-, and 12-months post-diverting loop ileostomy closure
measure: EORTC QLQ-C30 score
timeFrame: Baseline (day of patient recruitment), 2-, 6-, 9-, and 12-months post-restorative proctectomy
measure: EORTC QLQ-CR29 score
timeFrame: Baseline (day of patient recruitment), 2-, 6-, 9-, and 12-months post-restorative proctectomy
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: