PURPOSE: Oncologic concerns from high wound recurrence rates prompted a multi-institutional randomized trial to test the hypothesis that disease-free and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted or open colectomy. METHODS:Eight hundred seventy-two patients with curable colon cancer were randomly assigned to undergo laparoscopic-assisted or open colectomyat 1 of 48 institutions by 1 of 66 credentialed surgeons. Patients were followed for 8 years, with 5-year data on 90% of patients. The primary end point was time to recurrence, tested using a noninferiority trial design. Secondary endpoints included overall survival and disease-free survival. (Kaplan-Meier) RESULTS: As of March 1, 2007, 170 patients have recurred and 252 have died. Patients have been followed a median of 7 years (range 5-10 years). Disease-free 5-year survival (Open 68.4%, Laparoscopic 69.2%, P=0.94) and overall 5-year survival (Open 74.6%, Laparoscopic 76.4%, P=0.93) are similar for the 2 groups. Overall recurrence rates were similar for the 2 groups (Open 21.8%, Laparoscopic 19.4%, P=0.25). These recurrences were distributed similarly between the 2 treatment groups. Sites of first recurrence were distributed similarly between the treatment arms (Open: wound 0.5%, liver 5.8%, lung 4.6%, other 8.4%; Laparoscopic: wound 0.9%, liver 5.5%, lung 4.6%, other 6.1%). CONCLUSION:Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.
RCT Entities:
PURPOSE: Oncologic concerns from high wound recurrence rates prompted a multi-institutional randomized trial to test the hypothesis that disease-free and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted or open colectomy. METHODS: Eight hundred seventy-two patients with curable colon cancer were randomly assigned to undergo laparoscopic-assisted or open colectomy at 1 of 48 institutions by 1 of 66 credentialed surgeons. Patients were followed for 8 years, with 5-year data on 90% of patients. The primary end point was time to recurrence, tested using a noninferiority trial design. Secondary endpoints included overall survival and disease-free survival. (Kaplan-Meier) RESULTS: As of March 1, 2007, 170 patients have recurred and 252 have died. Patients have been followed a median of 7 years (range 5-10 years). Disease-free 5-year survival (Open 68.4%, Laparoscopic 69.2%, P=0.94) and overall 5-year survival (Open 74.6%, Laparoscopic 76.4%, P=0.93) are similar for the 2 groups. Overall recurrence rates were similar for the 2 groups (Open 21.8%, Laparoscopic 19.4%, P=0.25). These recurrences were distributed similarly between the 2 treatment groups. Sites of first recurrence were distributed similarly between the treatment arms (Open: wound 0.5%, liver 5.8%, lung 4.6%, other 8.4%; Laparoscopic: wound 0.9%, liver 5.5%, lung 4.6%, other 6.1%). CONCLUSION: Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.
Authors: Jimmy C M Li; Janet F Y Lee; Simon S M Ng; Raymond Y C Yiu; Sophie S F Hon; Wing Wa Leung; Ka Lau Leung Journal: Int J Colorectal Dis Date: 2010-06-08 Impact factor: 2.571
Authors: Dara O Kavanagh; David Gibson; Diarmaid C Moran; Myles Smith; Kate O Donnell; Emmanuel Eguare; Frank B V Keane; Diarmaid S O Riordain; Paul C Neary Journal: Int J Colorectal Dis Date: 2010-10-23 Impact factor: 2.571
Authors: Steven D Schwaitzberg; Kurt Roberts; John R Romanelli; David J Desilets; David Earle; Santiago Horgan; Lee Swanstrom; Eric Hungness; Nathaniel Soper; Michael L Kochman Journal: Surg Endosc Date: 2017-12-07 Impact factor: 4.584