Early Ileostomy Closure for Rectal Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jewish General Hospital
Disqualifiers: Immunosuppression, Major surgery, Complications, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of 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.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.
What data supports the idea that Early Ileostomy Closure for Rectal Cancer is an effective treatment?
The available research shows that Early Ileostomy Closure (EIC) is safe, feasible, and cost-effective. One study compared early closure (30 days after creation) to standard closure (90 days after creation) and found no significant differences in quality of life or bowel function between the two groups. This suggests that EIC can be as effective as the standard timing for closure, without negatively impacting patients' quality of life or bowel function.
12345What safety data exists for early ileostomy closure in rectal cancer treatment?
Multiple studies have shown that early ileostomy closure (EIC), defined as closure within 2 weeks of creation, is safe, feasible, and cost-effective. Research includes a randomized controlled multicenter trial evaluating its safety, a retrospective study comparing early versus late ileostomy reversal, and analyses of complications and risk factors associated with ileostomy closure. Despite these findings, EIC is not yet routine practice in North America.
12467Is Early Ileostomy Closure a promising treatment for rectal cancer?
Yes, Early Ileostomy Closure is a promising treatment for rectal cancer. It is considered safe, feasible, and cost-effective. It can improve the quality of life by reducing medical, surgical, or psychological complications and lowering treatment costs.
12458Eligibility Criteria
This trial is for adults over 18 with rectal cancer who've had a specific surgery (restorative proctectomy) and an ileostomy without complications or major health issues. They must have passed a leak test post-surgery, speak English or French, and not be on recent immunosuppressants.Inclusion Criteria
I had surgery for rectal cancer that involved creating a temporary ileostomy.
My CT scan after surgery showed no leaks in my intestine.
I am 18 years old or older.
Exclusion Criteria
My health conditions score is above 6 on the Charlson index.
I can speak and understand English or French and can give informed consent.
I had another major surgery at the same time as my main operation.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Post-operative Monitoring
Post-operative monitoring including a negative anastomotic leak test on post-operative day 7-9
1 week
1 visit (in-person)
Early Ileostomy Closure
Standardized reversal of diverting loop ileostomy between post-operative days 10-14 for the intervention group
1 week
1 visit (in-person)
Traditional Ileostomy Closure
Standardized reversal of diverting loop ileostomy no earlier than 12 weeks following index surgery for the control group
12 weeks
1 visit (in-person)
Follow-up
Participants are monitored for complications, quality of life, and bowel function at various intervals post-surgery
12 months
Multiple visits (in-person and virtual)
Participant Groups
The study tests if closing the ileostomy early after surgery is safe and beneficial compared to doing it later. It's a randomized-controlled trial in North America focusing on complication severity, quality of life, bowel function, and healthcare costs.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Ileostomy ClosureExperimental Treatment1 Intervention
Following 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.
Group II: Traditional closure (control)Active Control1 Intervention
Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo a standardized reversal of their diverting loop ileostomy. The latter will be performed with a stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia and will be performed no earlier than 12 weeks following their index surgery.
Early Ileostomy Closure is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Early Ileostomy Closure for:
- Rectal cancer
🇺🇸 Approved in United States as Early Ileostomy Closure for:
- Rectal cancer
🇨🇦 Approved in Canada as Early Ileostomy Closure for:
- Rectal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jewish General HospitalMontreal, Canada
London Health Sciences CentreLondon, Canada
St. Paul's Hospital, Providence Health CareVancouver, Canada
McGill University Health CentreMontréal, Canada
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Who Is Running the Clinical Trial?
Jewish General HospitalLead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreCollaborator
References
Patient and surgeon preferences for early ileostomy closure following restorative proctectomy for rectal cancer: why aren't we doing it? [2023]Early ileostomy closure (EIC), ≤ 2 weeks from creation, is a relatively new practice. Multiple studies have demonstrated that this approach is safe, feasible, and cost-effective. Despite the demonstrated benefits, this is neither routine practice, nor has it been studied, in North America. This study aimed to assess patient and surgeon perspectives about EIC.
The safety of early versus late ileostomy reversal after low anterior rectal resection: a retrospective study in 47 patients. [2021]This study aimed to clarify the safety of early closure in diverting ileostomy with lower anterior rectal-cancer resection.
Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial. [2021]The aim of this study was to assess quality of life and bowel function in patients undergoing early vs. standard ileostomy closure. We retrospectively assessed patients from our previous randomized controlled trial. Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other. Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared. Thirty-six months (17-97) after stoma closure, we contacted patients by phone and filled in two questionnaires-The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and low anterior resection syndrome (LARS) score. This index trial was not powered to assess the difference in bowel function between the two groups. All the patients in the SC group had anastomosis <6 cm from the anal verge compared to 42 of 43 (97.7%) in the EC group. There were no statistically significant differences between EC (26 patients) and SC (25 patients) groups in the EORTC QLQ-C30 and LARS questionnaires. Global quality of life was 37.2 (0-91.7; ±24.9) in the EC group vs. 34.3 (0-100; ±16.2) in the SC (p = 0.630). Low anterior resection syndrome was present in 46% of patients in the EC and 56% in the SC group (p = 0.858). Major LARS was found more often in younger patients. However, no statistical significance was found (p = 0.364). The same was found with quality of life (p = 0.219). Age, gender, ileostomy closure timing, neoadjuvant treatment, complications had no effect of worse bowel function or quality of life. There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size. None of our assessed risk factors had a negative effect on bowel function o quality of life.
[Early ileostomy closure in patients with rectal cancer. Primary results of the randomized controlled multicenter trial]. [2019]To evaluate safety of early closure of ileostomy in patients with rectal cancer after primary surgery.
Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? [2014]The influence of ileostomy closure timing on surgical and oncologic outcome was investigated in patients with locally advanced rectal cancer receiving adjuvant chemotherapy after low anterior resection.
Risk factors for complications after diverting ileostomy closure in patients who have undergone rectal cancer surgery. [2018]To clarify the risk factors for complications after diverting ileostomy closure in patients who have undergone rectal cancer surgery.
[Complications associated with closure of defunctioning loop ileostomy in low anterior resection of rectal cancer]. [2018]To analyze the complications of ileostomy closure and related risk factors.
Prospective study on the safety and feasibility of early ileostomy closure 2 weeks after lower anterior resection for rectal cancer. [2022]Transient loop ileostomies in rectal cancer surgery are generally closed after 2 or more months to allow adequate time for anastomotic healing. Maintaining the ileostomy may cause medical, surgical, or psychological complications; it also reduces the quality of life, and increase treatment costs. We performed this study to evaluate the safety and feasibility of early ileostomy closure 2 weeks postoperatively.