Ileostomy for Colorectal Cancer

(SH-SOC23 Trial)

Not currently recruiting at 2 trial locations

Overseen By Marcos Velez-Duran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SafeHeal Inc

Must not be taking: Steroids, Antimicrobials

Disqualifiers: Left colitis, Stage IV cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on the safety of a common surgery for colorectal cancer called low anterior resection (LAR), which often includes a diverting loop ileostomy (a temporary surgical opening in the small intestine to divert waste). Researchers aim to establish a clear method to measure and compare the safety of this standard treatment against other options by defining major complications. The trial seeks adults scheduled for this specific surgery for colorectal cancer who are willing to participate and adhere to its guidelines. Participants should not have certain medical conditions that might increase risks during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking 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 prior data suggests that diverting loop ileostomy is safe for colorectal cancer treatment?

Research shows that a diverting loop ileostomy, a temporary surgical opening in the small intestine, is generally well-tolerated. Studies have found that it significantly lowers the risk of anastomotic leaks, where surgical connections in the intestines might fail, thus improving recovery after colorectal cancer surgery.

However, complications can still occur. About 43% of patients experience issues like high-volume output, where the stoma produces a lot of fluid, and leakage from the stoma. These problems are common but manageable.

Additionally, research suggests that reversing the ileostomy, or closing it after temporary use, can be done safely. Early reversal has been found to be as safe as waiting longer and might reduce some risks associated with prolonged use.

Overall, while some risks and complications exist, the procedure offers significant safety benefits in preventing leaks after colorectal surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The diverting loop ileostomy is unique because it offers a proactive approach to managing complications after surgery for colorectal cancer, specifically after a low anterior resection. Unlike standard treatments that often focus on reactive management of post-surgery issues, this technique creates a temporary bypass for stool, which can help prevent leaks and infections at the surgical site. Researchers are excited about this technique because it might improve recovery times and reduce hospital stays, making the overall treatment process smoother and potentially more effective for patients.

What evidence suggests that diverting loop ileostomy is effective for colorectal cancer?

Research has shown that a diverting loop ileostomy, which participants in this trial will receive as part of the standard of care arm, can greatly reduce the risk of anastomotic leakage. This leakage occurs when the surgical join between two parts of the intestine leaks. This benefit is significant for patients undergoing rectal cancer surgery. However, studies also indicate that while it helps prevent leakage, it can lead to other complications. Some recent findings suggest that it might not improve short-term recovery, but it does offer protection against certain surgical risks. Overall, despite its imperfections, a diverting loop ileostomy effectively manages complications after colorectal cancer surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Marcos Velez-Duran

Principal Investigator

SafeHeal Inc

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Diverting loop ileostomy

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.

How Is the Trial Designed?

Group I: Standard of Care Arm Experimental Treatment 1 Intervention

Diverting loop ileostomy following low anterior resection of colorectal cancer

Diverting loop ileostomy is already approved in European Union, United States for the following indications:

Approved in European Union as Diverting loop ileostomy for:

• Rectal cancer
• Colorectal cancer

Approved in United States as Diverting loop ileostomy for:

• Rectal cancer
• Colorectal cancer

Who Is Running the Clinical Trial?

SafeHeal Inc

Lead Sponsor

Trials

4

Recruited

270+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11076370/

Meta-analysis: loop ileostomy versus colostomy to prevent ... A diverting stoma has been shown to significantly lower the risk of anastomotic leakage, thereby reducing the outcomes of AL [12]. Patients with ...

2. nature.com nature.com/articles/s41598-024-78409-z

Impact of diversion ileostomy on postoperative ... Recent studies have shown that diversion ileostomy may not improve short-term outcomes in patients undergoing rectal resection, but may increase ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9515269/

Morbidity of Temporary Loop Ileostomy in Patients with ... The aim of this study was to quantify the temporary loop ileostomy-related benefits as well as morbidity in patients with colorectal cancer.

4. link.springer.com link.springer.com/article/10.1007/s10151-024-03047-6

Outcomes of loop ileostomy after rectal resection for cancer Diverting ileostomy is a common procedure in rectal cancer surgery, but it is sometimes associated with a nonnegligible rate of complications.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06152276

NCT06152276 | SafeHeal Diverting Ileostomy Pivotal Study This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment. The data from this study could serve as ...

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480412007433

Loop ileostomies in colorectal cancer patients–morbidity ... Forty-three percent had complications related to the ileostomy; most common were high-volume output and leakage of stomal output. Morbidity after closure was ...