Selected article for: "control trial and feasibility study"

Author: Baik, Seung Hyuk; Gincherman, Mikhail; Mutch, Matthew G; Birnbaum, Elisa H; Fleshman, James W
Title: Laparoscopic vs open resection for patients with rectal cancer: comparison of perioperative outcomes and long-term survival.
  • Cord-id: hh50mq4z
  • Document date: 2011_1_1
  • ID: hh50mq4z
    Snippet: PURPOSE The aim of the study is to assess the safety and oncologic feasibility of laparoscopic-assisted resection for rectal cancer vs open rectal resection as a phase II pilot study for a planned randomized control trial. METHODS A case-matched controlled prospective analysis of 54 patients who underwent laparoscopic-assisted resection for stage I to III (no T4) rectal cancer within 12 cm of the anal verge from 2002 to 2005 was performed. Patients were matched with contemporary patients who und
    Document: PURPOSE The aim of the study is to assess the safety and oncologic feasibility of laparoscopic-assisted resection for rectal cancer vs open rectal resection as a phase II pilot study for a planned randomized control trial. METHODS A case-matched controlled prospective analysis of 54 patients who underwent laparoscopic-assisted resection for stage I to III (no T4) rectal cancer within 12 cm of the anal verge from 2002 to 2005 was performed. Patients were matched with contemporary patients who underwent open rectal cancer surgery (n = 108) in a 1 to 2 fashion. The perioperative clinical outcomes, postoperative pathology, and oncologic outcomes were compared between the groups. RESULTS The demographic data did not differ significantly between the groups. The laparoscopic group manifested early return of bowel function (P = .003). The complication rate was 22.2% in the laparoscopic group and 32.4% in the open group (P = .178). Local recurrence was similar (2.0% laparoscopic, 4.2% open, P = .417). The 5-year overall and disease-free survival rate also were similar (overall survival, 90.8% laparoscopic, 88.5% open, P = .261; disease-free survival, 80.8% laparoscopic, 75.8% open. P = .390). CONCLUSION The laparoscopic-assisted resection for rectal cancer was acceptable in terms of oncologic outcomes and perioperative clinical outcomes. The present data are the basis for a large-scale randomized trial for comparison of laparoscopic and open rectal cancer surgeries (American College of Surgeons Oncology Group Z6051).

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