Colorectal Cancer Clinical Trial
Official title:
A Prospective, Observational, Multi-center Study Assessing Early Post-Operative Recovery Following Laparoscopic Partial Large Bowel Resection
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.
Status | Completed |
Enrollment | 139 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals of Cleveland Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospital Case Medical Center | Cubist Pharmaceuticals LLC |
United States,
Delaney CP, Marcello PW, Sonoda T, Wise P, Bauer J, Techner L. Gastrointestinal recovery after laparoscopic colectomy: results of a prospective, observational, multicenter study. Surg Endosc. 2010 Mar;24(3):653-61. doi: 10.1007/s00464-009-0652-7. Epub 200 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to upper and lower GI recovery and post-operative hospital length of stay. | The primary outcome or end points were time to upper and lower GI recovery (GI-2: tolerance of solid food and bowel movement) and post-operative hospital length of stay. | One year | No |
Secondary | Postoperative ileus related mobidity. | The secondary outcome or endpoints are postoperative ileus(POI) related morbidity (postoperative nasogastric tub insertion or investigator-assisted POI resulting in prolonged hospital stay or readmission), conversion rate, and protocol-defined prolonged POI (GI-2>5 postoperative days.) | One year | No |
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