Clinical Trial
PROFILE Clinical Trial
A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection.
Mission
To provide the safest approach to colorectal surgery and reduce post-operative complications, improving recovery time and rehabilitation after surgery.
What are clinical trials?
“Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.” (https://medlineplus.gov/clinicaltrials.html)
Symptoms/conditions or diagnoses that would qualify for the trial
Anyone with rectal or colon cancer, diverticulitis, or inflammatory bowel disease who would like robotic minimally invasive surgery. Also, for patients with a colostomy desiring a reversal.
Where do they happen, what happens in this clinical trial, how is it administered?
Patients drink two bottles of either the investigational drug medication or placebo the night before surgery. The purpose of the study is to find out if the study drug is 1) safe (previous studies have shown that LB1148 is safe and well tolerated); 2) stops adhesions from forming after surgery; 3) Helps people quickly recover from symptoms of post-operative ileus
What is the desired outcome?
Please see attached pamphlet that is IRB
Any risks involved:
- Common side effects listed in consent: nausea, vomiting, moderate stomach pain, diarrhea, dizziness.
- Rare side effects listed in consent: vision problem, blood clot, seizure.
How am I protected:
You receive standard of care before, during, and after surgery regardless of participating in the study.