Early Post-Op Recovery After Partial Large Bowel Resection

NCT00492193 | Completed

• 2 other identifiers: 01-07-1414CL401
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diverticulitis; Colon Polyps; Colorectal Cancer

Keywords

Hand assist laparoscopic partial large bowel resection; Laparoscopic partial large bowel resection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative ileus related mobidity.

  One year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal Surgery clinic population

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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 2009 Aug 18.

  PMID: 19688390 RESULT

MeSH Terms

Conditions

Diverticulitis; Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Conor P. Delaney, MD, PhD

  University Hospitals of Cleveland/ Institute for Surgical Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 15, 2014

Record last verified: 2008-08

Locations

US (1)