Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT04355169
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia:
* partial small or large bowel resection with primary anastomosis
* radical cystectomy requiring bowel transection with primary anastomosis
* Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements:
* early removal of the nasogastric tube, which is defined as removal of the nasogastric tube at the end of surgery
* early ambulation, which is defined as ambulation on Day 1
* early diet advancement on Day 1
* Planned to receive primary postoperative pain management with opioid analgesia administered by any route.
* American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).
Exclusion Criteria:
* Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy.
* Scheduled for endoscopic or laparoscopic surgery.
* Complete bowel obstruction.
* Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease).
* More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant).
* More than 3 doses of an opioid (regardless of the route of administration) during the 7 days prior to surgery.
* Pregnancy or lactation.
* Presence of peritoneal catheter (for example, for dialysis or chemotherapy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04355169
Study Brief:
Protocol Section:
NCT04355169