Ileostomy for Colorectal Cancer

(SH-SOC23 Trial)

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: SafeHeal Inc

Must not be taking: Steroids, Antimicrobials

Disqualifiers: Left colitis, Stage IV cancer, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment diverting loop ileostomy for colorectal cancer?

The research suggests that a diverting loop ileostomy is commonly used to protect surgical connections in the intestines after colorectal cancer surgery, helping to prevent leaks and infections. This procedure is routine and can reduce the need for additional surgeries, although it may have some complications. ^{1 2 3 4 5}

Is ileostomy generally safe for humans?

Ileostomy is generally safe, but it can have complications like obstruction and leaks after closure. Studies show it has low mortality but can have high rates of other complications, so patients should be informed about these risks. ^{1 6 7 8 9}

How is the treatment diverting loop ileostomy unique for colorectal cancer?

A diverting loop ileostomy is unique because it temporarily reroutes waste to an external bag, protecting the healing area after colorectal surgery and reducing the risk of complications like infections. This approach is different from other treatments as it provides a physical barrier to protect surgical sites, which is not typically a feature of other colorectal cancer treatments. ^{1 2 4 8 10}

Research Team

Marcos Velez-Duran

Principal Investigator

SafeHeal Inc

Eligibility Criteria

This trial is for adults over 18 who are set to have a specific surgery (low anterior resection with diverting loop ileostomy) for colorectal cancer. They should be relatively active and able to care for themselves (ECOG ≤ 2), and willing to follow the study's procedures and visits.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

I am approved for a specific surgery to remove part of my lower colon due to cancer, as recommended by a team of doctors.

Exclusion Criteria

My cancer affects my ability to control bowel movements or is spreading in my pelvis.

I do not have an infection or need for antibiotics up to a week before surgery.

The subject is currently participating in another investigational drug or device study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo low anterior resection (LAR) and diverting loop ileostomy for colorectal cancer

9 months

Follow-up

Participants are monitored for major and early anastomotic complications

9 months

Treatment Details

Interventions

• Diverting loop ileostomy (Procedure)

Trial Overview The SafeHeal study is testing the safety of standard low anterior resection treatment for colorectal cancer by defining major complications. This will help compare its safety against other treatments by creating a new single safety endpoint.

Participant Groups

Group I: Standard of Care Arm Experimental Treatment 1 Intervention

Diverting loop ileostomy following low anterior resection of colorectal cancer

Who Is Running the Clinical Trial?

SafeHeal Inc

Lead Sponsor

Trials

4

Recruited

270+

Findings from Research

In a study of 72 patients with rectal cancer, closing a diverting loop ileostomy before or after adjuvant chemotherapy showed no significant difference in long-term survival rates, with 86% survival for the before closure group and 70% for the after closure group.

The study found that the average time from ileostomy creation to closure was significantly shorter for those who closed before chemotherapy (16.9 weeks) compared to those who closed after (33.6 weeks), suggesting that timing can be tailored to individual patient needs without compromising survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Survival Associated With Ileostomy Closure in Patients With Rectal Cancer Before and After Adjuvant Therapy. Brown, SR., Khan, B., Green, HJ., et al.[2022]

Complications from loop-derived ileostomy, such as dehydration and acute kidney injury, significantly impact chemotherapy adherence and overall survival in colon cancer patients, with a median overall survival of 56 months for those who did not complete chemotherapy.

Early reversal of ileostomy is associated with improved overall survival rates, reaching 100% at 5 years for early restitution patients, highlighting its importance in enhancing treatment outcomes for colon cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of ileostomy in the adjuvant treatment and outcome of colon cancer. Calderillo-Ruíz, G., López-Basave, HN., Muñoz-Montaño, WR., et al.[2023]

In a study of 262 colorectal cancer patients with loop ileostomies, 43% experienced complications related to the ileostomy, with high-volume output and leakage being the most common issues.

The study found that 23% of patients ended up with a permanent stoma, particularly those with postoperative complications or advanced cancer, suggesting that alternative stoma types may be preferable for emergency cases to reduce morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loop ileostomies in colorectal cancer patients--morbidity and risk factors for nonreversal. Gessler, B., Haglind, E., Angenete, E.[2022]

A case report of a 71-year-old man highlights a rare complication of a dysfunctional ileostomy caused by adhesions and the presence of Meckel's diverticulum, which led to small intestine volvulus and obstruction after rectal cancer surgery.

The authors suggest that during low anterior resection for rectal cancer, Meckel's diverticulum should be addressed, proposing its primary resection as a better surgical option and even considering it as a potential alternative for creating a stoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysfunctional loop ileostomy after low anterior resection for rectal cancer in the presence of Meckel's diverticulum: a case report. Spiridakis, KG., Sfakianakis, EE., Flamourakis, ME., et al.[2018]

In a study of 145 loop ileostomies performed on 139 patients, loop ileostomy (LI) demonstrated low morbidity rates of 16.5% during diversion and 8.6% after closure, indicating it is a safe option for fecal diversion in colorectal surgery.

The majority of loop ileostomies (91%) were successfully closed after an average of 3.6 months, supporting its effectiveness as a first-line stoma for both planned and emergency colorectal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results and indications of lateral ileostomy functionally terminated in colorectal surgery]. Petit, T., Maurel, J., Lebreton, G., et al.[2013]

Closure of temporary diverting ileostomy in patients with inflammatory bowel disease or peritonitis has a higher risk of postoperative complications (18.7%) compared to those with uncomplicated colorectal cancer, with significant reoperation rates (37.5% vs. 3.1%).

Preoperative radiological assessment of the ileostomy loop can help identify issues like stenosis, leading to better surgical planning and potentially reducing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical assessment of the closure of a temporary diverting ileostomy]. Sygut, A., Skowroński, A., Galbfach, P., et al.[2007]

In a study of 118 patients undergoing left-sided colonic or rectal resection with protective loop ileostomy, there was no observed mortality, indicating a high level of safety for this surgical intervention.

However, the study found a significant risk of stoma-related morbidity (35%) and complications related to reversal surgery, highlighting the need for careful patient selection for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of construction of protective loop ileostomies and reversal surgery for colorectal surgery. Abegg, RM., Brokelman, W., van Bebber, IP., et al.[2022]

Patients undergoing loop ileostomy closure after laparoscopic colorectal surgery experienced significantly shorter operative times (60.9 minutes) and hospital stays (4.9 days) compared to those who had open surgery (82.6 minutes and 5.8 days, respectively).

The overall complication rate was lower in the laparoscopic group (20.1% overall) compared to the open surgery group, with fewer cases of postoperative ileus and no enterocutaneous fistulas reported in the laparoscopic group, highlighting the safety and efficacy of laparoscopic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loop ileostomy closure after laparoscopic versus open surgery: is there a difference? Hiranyakas, A., Rather, A., da Silva, G., et al.[2021]

Closure of a protective loop ileostomy after colorectal resection is linked to low mortality rates, but it is associated with high morbidity rates, indicating that while the procedure is generally safe, complications are common.

The review highlights a lack of consensus on specific risk factors for complications following ileostomy closure, underscoring the importance of thorough patient counseling regarding potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications following construction and closure of loop ileostomies]. El-Hussuna, A., Bülow, S., Lauritsen, M.[2011]

In a study of 409 patients, early closure of a loop-ileostomy (within 150 days) significantly reduced the risk of postoperative complications compared to late closure (after 150 days), with 23.5% of patients experiencing complications overall.

Late closure was linked to more severe complications, particularly digestive issues like ileus, diarrhea, and stool incontinence, highlighting that the timing of closure is crucial for patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of Closure of a Protective Loop-Ileostomy Can Be Crucial for Restoration of a Functional Digestion. Werner, JM., Kupke, P., Ertl, M., et al.[2022]

References

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

Overall Survival Associated With Ileostomy Closure in Patients With Rectal Cancer Before and After Adjuvant Therapy. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Impact of ileostomy in the adjuvant treatment and outcome of colon cancer. [2023]

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

Loop ileostomies in colorectal cancer patients--morbidity and risk factors for nonreversal. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Dysfunctional loop ileostomy after low anterior resection for rectal cancer in the presence of Meckel's diverticulum: a case report. [2018]

5. France pubmed.ncbi.nlm.nih.gov

[Results and indications of lateral ileostomy functionally terminated in colorectal surgery]. [2013]

6. Poland pubmed.ncbi.nlm.nih.gov

[Clinical assessment of the closure of a temporary diverting ileostomy]. [2007]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Results of construction of protective loop ileostomies and reversal surgery for colorectal surgery. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Loop ileostomy closure after laparoscopic versus open surgery: is there a difference? [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

[Complications following construction and closure of loop ileostomies]. [2011]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Timing of Closure of a Protective Loop-Ileostomy Can Be Crucial for Restoration of a Functional Digestion. [2022]