PHASE III TRIAL--LAPAROSCOPIC COLECTOMY FOR COLON CANCER

Project: Research project

Description

Despite many important medical advances, surgery remains the primary
treatment modality for the majority of the 109,000 individuals who are
newly diagnosed with colon cancer each year. Surgery not only provides
extirpation of the primary tumor which relieves symptoms and prevents
complications, but in addition provides important staging information.
Although oncologic results from open colectomy are well-established, these
traditional resective and staging techniques are challenged by the
introduction of minimal access surgery. Laparoscopic cholecystectomy, an
example of minimal access resective surgery has rapidly become the
preferred surgical approach to cholelithiasis, due to significant
reductions in recovery time, disabilities, and costs. It has been proposed
that minimal access surgery of the colon may offer similar advantages.
Minimally invasive resections of the colon can be performed using
laparoscopic techniques to ligate vasculature, mobilize and exteriorize
bowel, and extracorporeal techniques to resect and anastomose bowel.
Collective preliminary data from a consortium of experienced laparoscopic
surgeons supports that laparoscopic-assisted colectomy is safe, feasible,
and reduces recovery times, disabilities, and costs. To date rigorous
quality of life and cost analyses have not been performed and further
concern has been raised regarding the adequacy of this technique for
staging and treatment of colon cancer, a common indication for colectomy.
A prospective randomized trial accruing 1,200 patients over three years is
proposed to address three SPECIFIC AIMS, The PRIMARY AIM of the study is
to test the hypothesis that disease-free survival and overall survival are
equivalent regardless of whether patients receive laparoscopic assisted or
open colectomy. If a significant adverse affect on cancer outcome is
detected, then no further analyses will be recommended. If, however,
laparoscopic-assisted colectomy does not adversely affect disease-free or
overall survival then further aims will be tested. The SECONDARY AIM of
the study is to determine the safety of laparoscopic-assisted colectomy
compared to open colectomy, specifically with the respect to operative
morbidities and mortality. The TERTIARY AIM of the study is to test the
hypothesis that laparoscopic-assisted colectomy is a cost effective
alternative to open colectomy and results in superior quality of life.
Measurable end points for the quality of life will include symptoms,
functional status and utilities, and early and late surgical
complications. Measurable end points for cost will include resource
utilization for all institutions and actual cost for two institutions. To
insure an efficient, successful, high-quality study, an intergroup
mechanism will be used to conduct the trial. Although surgical
participation will be limited to surgeons who demonstrate expertise in
laparoscopic colon surgery, the diverse geographic locations and practice
environments of the participating institutions is intended to maximize
diversity and the application of the results to the general community.
StatusFinished
Effective start/end date9/9/946/30/02

Funding

  • National Institutes of Health: $200,000.00
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health

Fingerprint

Colectomy
Colonic Neoplasms
Costs and Cost Analysis
Colon
Quality of Life
Geographic Locations
Cholelithiasis
Disease-Free Survival
Laparoscopic Cholecystectomy
Survival
Neoplasms
Laparoscopy
Safety
Mortality

ASJC

  • Medicine(all)