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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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