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Ileostomy for Colorectal Cancer (SH-SOC23 Trial)

N/A
Recruiting
Research Sponsored by SafeHeal Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to evaluate the safety of a common cancer treatment called low anterior resection (LAR). The goal is to define major complications associated with this treatment as a way to compare its safety with

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on assessing safety, side effects may include typical surgical complications such as infection, bleeding, pain at the surgery site, bowel obstruction or leakage from where the intestine was sewn together.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Early anastomotic complications
Overall major complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard of Care ArmExperimental Treatment1 Intervention
Diverting loop ileostomy following low anterior resection of colorectal cancer

Find a Location

Who is running the clinical trial?

SafeHeal IncLead Sponsor
3 Previous Clinical Trials
77 Total Patients Enrolled
Marcos Velez-DuranStudy DirectorSafeHeal Inc
~102 spots leftby Dec 2025
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