title: Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial.
abstract: OBJECTIVE
  Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease.
  
  
  OBJECTIVE
  To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen.
  
  
  METHODS
  A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection.
  
  
  METHODS
  Standard laparoscopic and open approaches were performed by the credentialed surgeons.
  
  
  METHODS
  The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation.
  
  
  RESULTS
  Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91).
  
  
  CONCLUSIONS
  Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00726622.
authors.affiliation: Baylor University Medical Center, Dallas, Texas.
authors.forename: James
authors.initials: J
authors.lastname: Fleshman
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
authors.forename: Megan
authors.initials: M
authors.lastname: Branda
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sargent
authors.affiliation: Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Boller
authors.affiliation: Indiana University School of Medicine, Indianapolis.
authors.forename: Virgilio
authors.initials: V
authors.lastname: George
authors.affiliation: Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.
authors.forename: Maher
authors.initials: M
authors.lastname: Abbas
authors.affiliation: Boone Hospital Center, Columbia, Missouri.
authors.forename: Walter R
authors.initials: WR
authors.lastname: Peters
authors.affiliation: Franciscan St. Francis Health, Indianapolis, Indiana.
authors.forename: Dipen
authors.initials: D
authors.lastname: Maun
authors.affiliation: MD Anderson Cancer Center, Houston, Texas.
authors.forename: George
authors.initials: G
authors.lastname: Chang
authors.affiliation: Vanderbilt University School of Medicine, Nashville, Tennessee.
authors.forename: Alan
authors.initials: A
authors.lastname: Herline
authors.affiliation: University of Chicago, Chicago, Illinois.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Fichera
authors.affiliation: Washington University, St Louis, Missouri.
authors.forename: Matthew
authors.initials: M
authors.lastname: Mutch
authors.affiliation: Cleveland Clinic-Weston, Weston, Florida.
authors.forename: Steven
authors.initials: S
authors.lastname: Wexner
authors.affiliation: The Oregon Clinic, Oregon Health & Science University, Portland.
authors.forename: Mark
authors.initials: M
authors.lastname: Whiteford
authors.affiliation: Lankenau Hospital, Wynnewood, Pennsylvania.
authors.forename: John
authors.initials: J
authors.lastname: Marks
authors.affiliation: Washington University, St Louis, Missouri.
authors.forename: Elisa
authors.initials: E
authors.lastname: Birnbaum
authors.affiliation: Ochsner Clinic, New Orleans, Louisiana.
authors.forename: David
authors.initials: D
authors.lastname: Margolin
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
authors.forename: David
authors.initials: D
authors.lastname: Larson
authors.affiliation: Lahey Clinic, Burlington, Massachusetts.
authors.forename: Peter
authors.initials: P
authors.lastname: Marcello
authors.affiliation: University of Chicago, Chicago, Illinois.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Posner
authors.affiliation: Lahey Clinic, Burlington, Massachusetts.
authors.forename: Thomas
authors.initials: T
authors.lastname: Read
authors.affiliation: University of Rochester, Rochester, New York.
authors.forename: John
authors.initials: J
authors.lastname: Monson
authors.affiliation: Stanford University, Palo Alto, California.
authors.forename: Sherry M
authors.initials: SM
authors.lastname: Wren
authors.affiliation: MD Anderson Cancer Center, Houston, Texas.
authors.forename: Peter W T
authors.initials: PW
authors.lastname: Pisters
authors.affiliation: Mayo Clinic.
authors.forename: Heidi
authors.initials: H
authors.lastname: Nelson
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000368:Aged; D013505:Digestive System Surgical Procedures / Q000379:methods*; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D007813:Laparotomy; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual; D011183:Postoperative Complications; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome