Early Ileostomy Closure for Rectal Cancer

Recruiting at 3 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

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. ^{1 2 3 4 5}

What 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. ^{1 2 4 6 7}

Is 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. ^{1 2 4 5 8}

Eligibility 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.

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

References

1. Germany 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? [2023]

2. England pubmed.ncbi.nlm.nih.gov

The safety of early versus late ileostomy reversal after low anterior rectal resection: a retrospective study in 47 patients. [2021]

3. Switzerland 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. [2021]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Early ileostomy closure in patients with rectal cancer. Primary results of the randomized controlled multicenter trial]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? [2014]

6. Japan pubmed.ncbi.nlm.nih.gov

Risk factors for complications after diverting ileostomy closure in patients who have undergone rectal cancer surgery. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Complications associated with closure of defunctioning loop ileostomy in low anterior resection of rectal cancer]. [2018]

8. Korea (South) 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. [2022]