Early Post-Op Recovery After Partial Large Bowel Resection

Completed

Conditions studied: Diverticulitis, Colon Polyps, Colorectal Cancer

In brief

The purpose of this trial is to gather information on the postoperative recovery time and hospital length of stay experienced by patients having laparoscopic surgeries. This trial will also collect data on daily surgical pain and pain medication and how it relates to recovery after surgery. In addition, the investigators will collect data on the use of pain medication and laxatives in patients following laparoscopic large bowel resection.

Key facts

Study ID

NCT00492193

Run by

University Hospitals Cleveland Medical Center

People needed

139

Starts

2007-06-01

Expected to finish

2008-05-01

Last updated by the study team

2014-12-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospitals of Cleveland Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.