Early Ileostomy Closure for Rectal Cancer Patients in North America
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorJewish General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Early Ileostomy Closure
Procedure/SurgeryFollowing a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo standardized reversal of their diverting loop ileostomy (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.
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: Early Ileostomy ClosureExperimental treatment 1 intervention
Group B: Traditional closure (control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Complications
Comprehensive complication index
Time frame
12-months post-restorative proctectomySecondary outcomes
1
Complications
Comprehensive complication index
Time frame
2-, 6-, and 9-months post-restorative proctectomy2
Occurrence of post-operative ileus following ileostomy reversal
Intolerance to oral intake in the absence of clinical or radiological signs of obstruction, measured prospectively after diverting loop ileostomy closure
Time frame
Monitored for from date of ileostomy closure to day of discharge from hospital3
Cost of patient care (in dollars)
Measured from the perspective of the healthcare system, by combining cost of each hospital admission (restorative proctectomy, diverting loop ileostomy closure, and any readmissions), interventions in any setting following restorative proctectomy, and stoma appliance-related costs (measured based on the average number of bags and stoma appliances used per week by each patient).
Time frame
Calculated at 6- and 12-months post restorative proctectomy4
Time to chemotherapy (weeks)
Number of weeks elapsed from date of restorative proctectomy to date of initiation of adjuvant chemotherapy
Time frame
Starting from restorative proctectomy post-operative day 1 through the course of the study (1 year follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jewish General Hospital
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov