Early Ileostomy Closure for Rectal Cancer

Recruiting at 4 trial locations

Overseen By Natasha Caminsky, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jewish General Hospital

Disqualifiers: Immunosuppression, Major surgery, Complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether early ileostomy closure is safe and beneficial for individuals with rectal cancer who have undergone specific surgeries. An ileostomy is a temporary opening in the abdomen to aid waste removal. The study compares early closure, known as Early Ileostomy Closure (EIC), to the usual later closure, focusing on complications, quality of life, and costs. It suits those who have had certain rectal cancer surgeries and a clear scan showing no leaks post-surgery. As an unphased trial, it allows participants to contribute to significant research that could enhance future treatment options.

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 prior data suggests that early ileostomy closure is safe for rectal cancer patients?

Research has shown that closing a temporary opening in the abdomen sooner than usual after rectal cancer surgery, known as early ileostomy closure (EIC), is generally safe. Studies have found that patients undergoing EIC experience fewer complications compared to those with later closure. For instance, one study found that early closure resulted in shorter surgery times and less bleeding. Another study confirmed that EIC did not increase the risk of complications after surgery.

A meta-analysis, which combines results from several studies, concluded that early stoma closure is safe and practical, with fewer risks of complications. In some cases, patients had their ileostomies closed just 8 to 13 days after surgery, and this was found to be safe for those selected for early closure.

Overall, research supports that EIC is well-tolerated by patients and does not lead to more complications than the traditional method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early ileostomy closure for rectal cancer because it could significantly speed up recovery for patients. Unlike traditional closure methods, which typically occur no earlier than 12 weeks after surgery, this approach aims to reverse the ileostomy just 10-14 days after surgery. This quicker timeline can potentially reduce complications and improve the quality of life for patients by restoring normal bowel function much sooner. The hope is that early closure will enhance postoperative outcomes without increasing the risk of complications.

What evidence suggests that early ileostomy closure is effective for rectal cancer patients?

This trial will compare Early Ileostomy Closure with Traditional Closure for rectal cancer patients. Research has shown that early ileostomy closure can benefit these patients. Studies have found that it results in shorter surgeries and less bleeding. It is considered safe when performed about 8 to 13 days after the initial surgery for certain patients. However, some research suggests that early closure might lead to more surgical complications than waiting longer. Overall, evidence supports early closure as a viable option, but potential risks should be carefully considered. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

My health conditions score is above 6 on the Charlson index.

I had another major surgery at the same time as my main operation.

I have not received immunosuppressive therapy within 6 weeks before surgery.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Early Ileostomy Closure

Trial Overview 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.

How Is the Trial Designed?

Group I: Early Ileostomy Closure Experimental Treatment 1 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 Control 1 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

Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials

144

Recruited

283,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

In a study of 47 patients who underwent diverting ileostomy after lower rectal-cancer resection, early closure (within 90 days) was associated with a higher rate of minor complications (48.3%) compared to late closure (27.8%).

Despite the increased minor complications, the rate of severe complications was similar between early and late closure groups, suggesting that early stoma closure does not increase the risk of major complications and may be considered in future treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of early versus late ileostomy reversal after low anterior rectal resection: a retrospective study in 47 patients. Fukudome, I., Maeda, H., Okamoto, K., et al.[2021]

In a study of 30 patients who underwent rectal cancer surgery, early closure of transient loop ileostomies at 2 weeks postoperatively was found to be safe, with only one case of wound infection and no new anastomotic leaks.

The early closure did not significantly delay the start of adjuvant chemotherapy, averaging 5.37 weeks after surgery, suggesting that this approach can improve patient quality of life and reduce treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study on the safety and feasibility of early ileostomy closure 2 weeks after lower anterior resection for rectal cancer. Lee, KH., Kim, HO., Kim, JS., et al.[2022]

In a study comparing early ileostomy closure (30 days) to standard closure (90 days) in patients who had rectal cancer surgery, no significant differences were found in quality of life or bowel function between the two groups, as assessed by the EORTC QLQ-C30 and LARS questionnaires.

Both groups reported similar levels of low anterior resection syndrome and overall quality of life, suggesting that the timing of ileostomy closure does not impact long-term outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dulskas, A., Petrauskas, V., Kuliavas, J., et al.[2021]

Early closure of ileostomy (8-13 days post-surgery) in rectal cancer patients is safe, showing similar postoperative morbidity rates compared to delayed closure (12 weeks), with rates of 6.45% vs. 5.88%.

The duration of reconstructive surgery was significantly shorter for early closure (50 minutes) compared to delayed closure (71 minutes), suggesting that early closure may be more efficient in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early ileostomy closure in patients with rectal cancer. Primary results of the randomized controlled multicenter trial]. Gallyamov, EA., Agapov, MA., Lutsevich, OE., et al.[2019]

In a study of 165 patients with locally advanced rectal cancer, the timing of ileostomy closure—either during or after adjuvant chemotherapy—did not significantly affect postoperative complications, hospital stay, recurrence rates, or overall survival.

Patients who underwent closure during chemotherapy had a lower pathologic stage compared to those who closed after chemotherapy, suggesting that timing may be influenced by the severity of the disease rather than impacting surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? Tulchinsky, H., Shacham-Shmueli, E., Klausner, JM., et al.[2014]

In a study of 245 patients undergoing ileostomy closure, the overall complication rate was 13.5%, with surgical site infections being the most common issue, affecting 8.6% of patients.

The use of subcutaneous vacuum drainage significantly reduced the risk of surgical site infections, particularly in patients whose total operation time exceeded 90 minutes, highlighting its effectiveness as a protective measure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications associated with closure of defunctioning loop ileostomy in low anterior resection of rectal cancer]. Pan, H., Wang, L., Peng, Y., et al.[2018]

A study involving 48 rectal cancer survivors revealed that many patients found living with a stoma challenging, with 72.9% expressing interest in early ileostomy closure (EIC) due to its potential benefits for quality of life and quicker return to normal function.

Surgeons identified several advantages to EIC but also noted significant logistical barriers to its implementation, indicating a strong interest in conducting a North American randomized-controlled trial to further investigate its efficacy and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and surgeon preferences for early ileostomy closure following restorative proctectomy for rectal cancer: why aren't we doing it? Caminsky, NG., Moon, J., Morin, N., et al.[2023]

In a study of 240 patients who underwent diverting ileostomy closure after rectal cancer surgery, age 72 years or older, a closure interval of 6 months or longer, and an operation time of 145 minutes or longer were identified as significant risk factors for postoperative complications.

The analysis indicated that these factors are independent risk factors, suggesting that ileostomy closure should ideally occur within 6 months post-surgery to minimize the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for complications after diverting ileostomy closure in patients who have undergone rectal cancer surgery. Nakamura, T., Sato, T., Naito, M., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8860143/

Early versus delayed defunctioning ileostomy closure after low ... We performed a systematic review and meta-analysis with trial sequential analysis (TSA) to answer whether early closure of defunctioning ileostomy may be ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1015958423001550

Outcome of early versus late ileostomy closure in patients ... Patients undergoing early closure of the ileostomy had significantly shorter operation duration (p<0.001) and lower intraoperative bleeding (p<0.001) compared ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05027737

Early Ileostomy Closure for Rectal Cancer Patients in North ... 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 ...

4. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2017/02000/early_closure_of_a_temporary_ileostomy_in_patients.11.aspx

Early Closure of a Temporary Ileostomy in Patients With... It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or ...

5. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04090-9

Post-surgical morbidity in early versus late closure of ... Conclusion. EC of defunctioning ileostomy in rectal cancer patients results in increased surgical complications compared to patients with LC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6306500/

Prospective study on the safety and feasibility of early ... Transient loop ileostomies in rectal cancer surgery are generally closed after 2 or more months to allow adequate time for anastomotic healing.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02665026

NCT02665026 | Effectiveness and Safety Study on ... This study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk ...

8. nature.com nature.com/articles/s41598-023-33006-4

Early versus late reversal of diverting loop ileostomy in ... A meta-analysis including seven of the trials concluded that early stoma reversal was safe and feasible and associated with a reduced risk of ...