Randomized Double-Blind Placebo-Controlled Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Gastroenterology
    Surgery
  • Age: Between 18 years - 99 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Individuals who are scheduled for an elective bowel resection (BR) procedure. The BR may be open or laparoscopic (straight, hand-assisted, or robotically assisted) and may include small BR, large BR, total colectomy with ileo-rectal anastomosis, or rectal resection. The anticipated hospital stay is = 4 days with at least 3 overnight stay.
    2. American Society of Anesthesiologist Physical Status Score of 1 to 3.
    3. SARS-CoV-2 testing is mandatory for all potential subjects prior to enrollment (eg, within 72 hours of day of surgery) and positive-result exclusionary.
    4. Participants with prior history of COVID-19 must be confirmed recovered per CDC criteria and have a SARS-CoV-2 negative test result.

You may not be eligible for this study if the following are true:

    1. Individuals scheduled for a type of surgery not listed in the inclusion criteria
    2. Individuals requiring surgery for an ongoing infection, bowel obstruction or perforated bowel.
    3. Individuals requiring a ventral hernia repair through component separation techniques or placement of mesh.
    4. Individuals requiring any additional resections beyond the intestine (eg, hepatectomy, distal pancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection) or concomitant surgeries (with the exception of biopsies).
    5. Individuals requiring resection of the rectum (resection of a portion of the rectum is permitted as part of a low anterior resection).
    6. Individuals requiring the formation of a stoma (ileostomy or colostomy) or who have a functional colostomy or ileostomy.
    7. Individuals who have an ongoing history of short bowel syndrome, chronic constipation (= 3 spontaneous BMs/week), chronic diarrhea, or complete bowel obstruction.



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