Study concept and design: Fleshman, Sargent, Boller, George, Abbas, Chang, Herline, Wexner, Margolin, Marcello, Posner, Read, Monson, Wren, Nelson.
Acquisition, analysis, or interpretation of data: Fleshman, Branda, Sargent, George, Peters, Maun, Chang, Herline, Fichera, Mutch, Wexner, Whiteford, Marks, Birnbaum, Margolin, Larson, Marcello, Monson, Pisters.
Drafting of the manuscript: Fleshman, Sargent, George, Abbas, Herline, Fichera, Mutch, Larson.
Critical revision of the manuscript for important intellectual content: Fleshman, Branda, Sargent, Boller, Abbas, Peters, Maun, Chang, Wexner, Whiteford, Marks, Birnbaum, Margolin, Larson, Marcello, Posner, Read, Monson, Wren, Pisters, Nelson.
Statistical analysis: Branda, Sargent, Boller, Marks.
Obtained funding: Fleshman, Herline, Nelson.
Administrative, technical, or material support: Sargent, Boller, Whiteford, Marks, Margolin, Larson, Posner, Read, Wren, Pisters, Nelson.
Study supervision: Fleshman, Sargent, George, Herline, Wexner, Marks, Monson, Nelson.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Branda reports receiving research support from Covidien unrelated to this work. Dr Peters reports receiving personal fees from Ethicon EndoSurgery unrelated to this work. Dr Change reports serving on the scientific advisory board for Johnson & Johnson. Dr Wexner reports owning stock options in Asana Medical, LifeBond, and Renew Medical; consulting for Brace Pharmaceuticals, CareFusion, Edwards LifeSciences, Incontinence Devices Inc, Karl Storz Endoscopy America, LifeBond, Mederi Therapeutics, Medtronic, and Novadaq; and receiving inventor’s income from Covidien, Karl Storz Endoscopy America, and Unique Surgical Innovations. Dr Marcello reports receiving honoraria from Applied Medical, Covidien, and Olympus for activities unrelated to this work. Dr Wren reports having a consulting relationship with Intuitive Surgical Inc, manufacturer of the only surgical robotic system commercially available used for minimally invasive rectal cancer surgery; this relationship was not in place during the conduct of the research reported herein. Dr Nelson reports receiving royalties for a licensed patent on a robotic stapling device. No other disclosures were reported.
Funding/Support: This work was supported by a grant from the National Cancer Institute, awarded to the American College of Surgeons Oncology Group (ACOSOG). The American Society of Colon and Rectal Surgeons provided support for the comparison of the quality-of-life survey results between the laparoscopic and open resection arms. The Society of American Gastrointestinal and Endoscopic Surgeons provided support for the evaluation of instrumentation in the laparoscopic resection–treated patients. In addition, the Covidien Company provided unrestricted research support to the ACOSOG infrastructure for the trial.
Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The study was monitored through the National Cancer Institute (NCI) and Clinical Trials Support Unit with ACOSOG (now part of Alliance).
Study Group Members: Advocate Lutheran General Hospital, Park Ridge, IL (Leela Prasad); Allegheny General Hospital, Pittsburgh, PA (James McCormick); Baylor University Medical Center, Dallas, TX (James W. Fleshman); Boone Hospital Center, Columbia, MO (Walter Peters); Cleveland Clinic Foundation, Cleveland, OH (Luca Stocchi); Cleveland Clinic–Weston, Weston, FL (Steven Wexner); Columbia University Medical Center, New York, NY (Daniel Feingold); Duke University Medical Center, Durham, NC (Linda Farkas); Franciscan Saint Francis Health–Mooresville, Mooresville, IN (Dipen C. Maun); Indiana University Hospital/Melvin and Bren Simon Cancer Center, Indianapolis (Virgilio George); Integris Cancer Institute of Oklahoma, Oklahoma City (Chris M. Davis); Indiana University Health North Hospital, Carmel (Virgilio George); John B. Amos Cancer Center, Columbus, GA (William Taylor); John F. Kennedy Medical Center, Edison, NJ (Bertram Chinn); John Muir Medical Center, Walnut Creek, CA (Samuel C. Oommen); John Muir Medical Center–Concord Campus, Concord, CA (Samuel C. Oommen); Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA (Maher Abbas); Lahey Hospital and Medical Center, Burlington, MA (Peter Marcello); Lankenau Medical Center, Wynnewood, PA (John Marks); MD Anderson Cancer Center, Houston, TX (George Chang); Mayo Clinic, Rochester, MN (David Larson); Mayo Clinic, Scottsdale, AZ (Tonia Young-Fadok); Memorial Sloan Kettering Cancer Center, New York, NY (Martin Weiser); NorthShore University HealthSystem–Evanston Hospital, Evanston, IL (Marc Singer); Northwestern University, Chicago, IL (Amy Halverson); Ochsner Medical Center Jefferson, New Orleans, LA (David Margolin); Providence Portland Medical Center, Portland, OR (Mark Whiteford); Rush University Medical Center, Chicago, IL (Marc Brand, Theodore Saclarides); Saint Joseph's Healthcare Charlton Campus, Hamilton, Ontario, Canada (Mehran Anvari); Saint Paul's Hospital, Vancouver, British Columbia, Canada (P. Phang); Sidney and Lois Eskenazi Hospital, Indianapolis, IN (Virgilio George); Spectrum Health–Blodgett Campus, Grand Rapids, MI (Rebecca Hoedema); State University of New York Upstate Medical University, Syracuse (Jiri Bem); Stony Brook University Medical Center, Stony Brook, NY (Roberto Bergamaschi); Tampa General Hospital, Tampa, FL (Jorge Marcet); University of Chicago, Chicago, IL (Alessandro Fichera, Mitchell Posner); University of Iowa Hospitals and Clinics, Iowa City (John Byrn); University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, PA (Herbert Zeh); Vanderbilt University/Ingram Cancer Center, Nashville, TN (Alan Herline); Washington University School of Medicine, Saint Louis, MO (Elisa Birnbaum, James Fleshman, Matthew Mutch, Paul Wise); Western Pennsylvania Hospital, Pittsburgh (James McCormick).
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Enrolling institutions received per capita funding from the US NCI according to accrual to the protocol.
Additional Contributions: The Steering Committee provided support and guidance during the entire process and deserves special acknowledgment: Maher Abbas, MD (Cleveland Clinic Abu Dhabi), Megan Branda, MS (Alliance Statistics and Data Center, Mayo Clinic), George Chang, MD (MD Anderson Cancer Center), Alessandro Fichera, MD (University of Chicago), Alan Herline, MD (Vanderbilt University School of Medicine), Matthew Mutch, MD (Washington University in St Louis), John Marks, MD (Lankenau Hospital), Peter Marcello, MD (Lahey Clinic), David Margolin, MD (Ochsner Clinic), John Monson, MD (University of Rochester), Peter W. T. Pisters, MD (MD Anderson Cancer Center), Mark Whiteford, MD (The Oregon Clinic, Oregon Health & Science University), Thomas Read, MD (Lahey Clinic), Steven Wexner, MD (Cleveland Clinic–Weston), Sherry M. Wren, MD (Stanford University), and Heidi Nelson, MD (Mayo Clinic). We would also like to thank our data quality specialist Pam Fain Pribyl, BA (Mayo Clinic), and analyst Xiomara Carrero, BS (Mayo Clinic). All trial participants contributed to study design and participated in numerous meetings at American College of Surgeons Oncology Group Trial development meetings. None of these individuals received compensation for their role in this study.