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:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00492193
Eligibility Criteria:
Inclusion Criteria:
* be male or female at least 18 years of age
* be scheduled for laparoscopic (SL or HAL) partial large bowel resection with primary anastomosis.
* have an American Society of Anesthesiologists Physical Status Score of P1 to P3 (Appendix C.1 of the full protocol).
* are scheduled to receive postoperative pain management primarily with opioid analgesia via intravenous (IV) patient-controlled analgesia (PCA)
* are scheduled to have the NG tube removed on the morning of POD 1
* are able to read, write, and fully understand the language of the study diary
* be able to understand the study procedure, agrees to participate in the study program, and voluntarily provides informed consent.
Exclusion Criteria:
* be scheduled for a total colectomy, ileal pouch-anal anastomosis, colostomy, ileostomy, right HAL colectomy or have a history of total colectomy, gastric bypass, previous bowel resection or short bowel syndrome.
* has a complete bowel obstruction
* has taken therapeutic doses of opioids for 7 consecutive days immediately before surgery.
* has participated in a clinical trial with alvimopan or has taken alvimopan in the past 30 days.
* has a diagnosed history of alcoholism or drug addiction (eg, opioids or other drugs of abuse) within 1 year of the surgery date (Day 0).
* has a diagnosed history of constipation, pelvic floor disorder, or GI disorders known to affect bowel function (eg, chronic diarrhea)
* has a history of laxative dependence or daily use (ie, hyperosmotics, mineral oil, saline, stimulants, bulking agents, suppositories, lubricants, enemas, or any other natural products that promote bowel motility or cleansing)
* has, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, GI, metabolic disorders or mental conditions (e.g., depression, psychosis) that might confound the results of the study or pose additional risk to the subject.
* has participated in another investigational drug or medical device study within the last 30 days or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study.
* is unwilling or unable to complete the study diary.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00492193
Study Brief:
Protocol Section:
NCT00492193