EVIDENCE-BASED ONCOLOGYLaparoscopically assisted colectomy is as safe and effective as open colectomy in people with colon cancer: Abstracted from: Nelson H, Sargent D, Wieand HS, et al; for the Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050–2059.☆,☆☆,☆☆☆
Section snippets
Background
Evidence to support the use of laparoscopically assisted surgery in people undergoing colectomy for colon cancer is limited.
Objective
To determine if laparoscopically assisted surgery is as effective as open surgery in people undergoing colectomy for colon cancer.
Setting
48 centres in the United States; recruitment from August 1994 and August 2001.
Method
Multicentre randomised controlled noninferiority trial.
Participants
872 people (∼50% male, median age ∼70 years, range 28–96 years) with histologically confirmed adenocarcinoma of the colon at TNM stage 0 (n = 53, 6%), stage I (n = 265, 30%), stage II (n = 282, 33%), stage III (n = 233, 27%), stage IV (n = 26, 3%) or unknown. People were excluded if they had: signs of prohibitive abdominal adhesions; advanced local or metastatic disease; rectal or transverse colon cancer; acute bowel obstruction or perforation from cancer; severe medical illness; inflammatory bowel
Intervention
Participants were randomised to open or laparoscopically assisted colectomy. Both procedures were performed according to protocol guidelines with the same extent of resection for both groups. For laparoscopically assisted colectomy, the abdomen was explored, colon mobilised, and critical structures identified via pneumoperitoneal and intracorporeal approaches. The vascular pedicle was ligated for sigmoid and left sided colectomies and the bowel exteriorised through a small incision for
Main outcomes
Time to tumour recurrence (defined as the time from randomisation to the time either of first recurrence [confirmed by imaging or pathological evaluation], or death); disease-free survival; overall survival; complications; variables related to recovery and quality of life.
Main results
Benefits. The rates of tumour recurrence, overall survival and disease-free survival were similar after laparoscopically assisted colectomy compared with open colectomy in people with colon cancer (see Evidence Table 1).
Adverse events. Perioperative recovery was significantly faster with laparoscopically assisted surgery, although 30 day complications were similar between groups (see Evidence Table 2).
Treatment related mortality. There were no significant differences in treatment related
Authors’ conclusions
Laparoscopically assisted colectomy is as safe and effective as open colectomy in people with colon cancer. Although laparoscopic surgery had longer operative times, it was associated with less pain, less narcotic use, and a shorter hospital stay.
Method notes
Random error Power calculation 81% power to detect a hazard ratio for tumour recurrence of 1.23 (in favour of open colectomy compared with laparoscopically assisted colectomy), assuming a 3 year recurrence-free rate of 80% in people treated with open colectomy (significance not stated). This was a non-inferiority trial, i.e., the trial was not designed to test if laparoscopic surgery was superior to conventional surgery Bias Measures to prevent bias Comparator bias Was true uncertainty about relative
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Sources of funding: Supported by grants from the National Cancer Institute, USA.
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For Correspondence: Dr. Heidi Nelson, Division of Colon and Rectal Surgery, Mayo Clinic, 200 First St. SW, Rochester, MN 55905.
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Abstract provided by Bazian Ltd, London.