Early Post-Op Recovery After Partial Large Bowel Resection
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective, Observational, Multi-center Study Assessing Early Post-Operative Recovery Following Laparoscopic Partial Large Bowel Resection|
- Time to upper and lower GI recovery and post-operative hospital length of stay. [ Time Frame: One year ] [ Designated as safety issue: No ]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.
- Postoperative ileus related mobidity. [ Time Frame: One year ] [ Designated as safety issue: No ]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.)
|Study Start Date:||June 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Laparoscopic surgery was initially performed by surgeons in France in 1987 and was introduced in the United States in 1988. This minimally invasive procedure was performed for cholecystectomy, and is now the standard of care in the treatment of gallbladder disease. Recent advances in laparoscopic surgery and its success in cholecystectomy have permitted the procedure to be used for treating a variety of diseases and for diagnosing and staging.
Minimally invasive laparoscopic surgery has advantages over conventional open surgery, including smaller incisions, earlier gastrointestinal (GI) recovery, shorter hospital stays, less pain, and fewer complications. In recent years evidence is accumulating for some operations that laparoscopic procedures produce outcomes that are comparable to those produced by routine open surgery and may actually surpass others.
Whereas laparoscopic surgery has been successful and well accepted for various abdominal and pelvic surgeries, its use in the area of colorectal surgery has progressed at a slower rate. There are challenges impacting the wider use of laparoscopic bowel resection (LBR). These include the technical difficulty associated with the size of the colon, the need for complete immobilization of the bowel and the need for a watertight, non-leaking anastomosis. In addition, the equipment is expensive and surgeons require specialized training.
Results from studies in colon cancer now indicate that LBR reduces perioperative morbidity, and decreases hospital stay with comparable cancer-related survival as compared to open colectomy. The use of LBR in short-term outcomes is increasing because clinical trial data have demonstrated superiority of LBR, particularly in short-term outcomes over conventional open surgery.
Gastrointestinal recovery and related patient outcomes during the early postoperative period following open segmental colon resection have been extensively evaluated in previous randomized, controlled, multicenter trials. Current data in laparoscopic colectomy have been collected from retrospective, single center clinical trials which lacked standardized definitions and endpoints. Therefore, this prospective, multicenter study in LBR is being undertaken to determine how this surgical technique impacts GI recovery and related outcomes relative to the open laparotomy.
The primary objective of this study is to assess the clinical course of gastrointestinal (GI) recovery and hospital length of stay in subjects undergoing laparoscopic partial large bowel resection. The secondary objective is to assess the immediate post discharge clinical course of subjects undergoing laparoscopic bowel resection with respect to opioid-induced GI effects, daily surgical pain, opioid consumption and laxative use.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492193
|United States, Ohio|
|University Hospitals of Cleveland Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Conor P. Delaney, MD, PhD||University Hospitals of Cleveland/ Institute for Surgical Innovation|