Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men

A Randomized Clinical Trial

Fitzgibbons, Robert J. Jr MD
Giobbie-Hurder, Anita MS
Gibbs, James O. PhD
Dunlop, Dorothy D. PhD
Reda, Domenic J. PhD
McCarthy, Martin Jr PhD
Neumayer, Leigh A. MD
Barkun, Jeffrey S. T. MD
Hoehn, James L. MD
Murphy, Joseph T. MD
Sarosi, George A. Jr MD
Syme, William C. MD
Thompson, Jon S. MD
Wang, Jia MS
Jonasson, Olga MD

Department of Surgery, Creighton University, Omaha, Neb (Dr Fitzgibbons); Department of Surgery, Omaha VA Medical Center, Omaha (Drs Fitzgibbons and Thompson); VA Cooperative Studies Program Coordinating Center, Hines, Ill (Dr Reda and Mss Giobbie-Hurder and Wang); Department of Preventive Medicine (Dr McCarthy) and Institute for Healthcare Studies (Drs Dunlop and Gibbs), Northwestern University, Chicago, Ill; Salt Lake City VA Health Care System and Department of Surgery, University of Utah, Salt Lake City (Dr Neumayer); Department of Surgery, McGill University, Montreal, Quebec (Dr Barkun); Marshfield Clinic Department of Surgery, Marshfield, Wis (Dr Hoehn); University of Texas Southwestern Medical Center at Dallas and Department of Surgery, Dallas VA Medical Center, Dallas, Tex (Drs Murphy and Sarosi); Lovelace Clinic Department of Surgery, Albuquerque, NM (Dr Syme); Department of Surgery, University of Nebraska, Omaha (Dr Thompson); and Department of Surgery, University of Illinois, Chicago (Dr Jonasson).

Corresponding Author: Olga Jonasson, MD, Department of Surgery, University of Illinois, 1514 W Jackson Blvd, Chicago, IL 60607 ([email protected]).

Author Contributions: Dr Jonasson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Fitzgibbons, Gibbs, Dunlop, Reda, McCarthy, Neumayer, Jonasson.

Acquisition of data: Fitzgibbons, Giobbie-Hurder, Barkun, Hoehn, Murphy, Sarosi, Syme, Thompson, Jonasson.

Analysis and interpretation of data: Fitzgibbons, Giobbie-Hurder, Gibbs, Dunlop, Reda, McCarthy, Neumayer, Barkun, Hoehn, Sarosi, Syme, Thompson, Wang, Jonasson.

Drafting of the manuscript: Fitzgibbons, Giobbie-Hurder, Gibbs, Dunlop, McCarthy, Neumayer, Jonasson.

Critical revision of the manuscript for important intellectual content: Fitzgibbons, Giobbie-Hurder, Gibbs, Dunlop, Reda, McCarthy, Neumayer, Barkun, Hoehn, Murphy, Sarosi, Syme, Thompson, Wang, Jonasson.

Statistical analysis: Giobbie-Hurder, Dunlop, Reda, Wang.

Obtained funding: Fitzgibbons, Jonasson.

Administrative, technical, or material support: Fitzgibbons, Gibbs, Reda, McCarthy, Neumayer, Jonasson.

Study supervision: Fitzgibbons, Gibbs, Neumayer, Barkun, Hoehn, Murphy, Sarosi, Syme, Thompson, Jonasson.

Financial Disclosures: Dr Fitzgibbons has been retained as an expert witness by Davol, manufacturer of mesh plug used in plug and patch surgical repair of hernia and is a consultant for TyRx Pharma Inc, developers of an antibiotic- and local anesthetic–impregnated mesh for tension-free repair of hernia. No other authors reported disclosures.

Funding/Support This study was funded by Agency for Healthcare Research and Quality grant RO1 HS 09860, and the American College of Surgeons provided logistic and budget management support.

Role of the Sponsors: The Agency for Healthcare Research and Quality had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. The American College of Surgeons had no role in the analysis and interpretation of data or in the preparation, review, or approval of the manuscript.

Members of the Watchful Waiting vs Open Tension-free Repair Study (asterisks denote former participants): Chair: R. J. Fitzgibbons (Creighton University); Biostatistician: A. Giobbie-Hurder; Health Scientist: J. O. Gibbs; Lead Health Economist: L. Manheim, D. Dobrez*; Health Economist: K. Stroupe; Patient-Reported Outcomes Consultant: M. McCarthy; Coinvestigator: L. Neumayer; National Study Coordinator: K. Kaczmarek; Data and Safety Monitoring Board: H. Buchwald (University of Minnesota Hospital and Clinics), R. Burney (University of Michigan), B. Craig (Purdue University), L. Kazis (Edith Norse Rogers Memorial Veterans Hospital), K. Kelly (Mayo Clinic–Scottsdale); Executive Committee: C. J. Carrico (deceased) (University of Texas Southwestern Medical Center, Dallas); J. Chmiel, D. Dobrez*, D. Dunlop, J. O. Gibbs, L. Manheim (Northwestern University); R. J. Fitzgibbons, Jr (Creighton University); J. Thompson (University of Nebraska Medical Center); A. Giobbie-Hurder, D. Reda (Cooperative Studies Program Coordinating Center); W. G. Henderson* (University of Colorado Health Outcomes Program); O. Jonasson (University of Illinois); J. Barkun, J. Meakins* (McGill University); J. Hoehn (Marshfield Clinic); J. Murphy, G. Sarosi (UT Southwestern Medical Center); W. Syme (Lovelace Health Systems); Site Personnel: J. Murphy, G. Sarosi, D. Climer, L. Kim* (Dallas, Tex); W. Syme, A. Von Worley, M. Kestner* (Albuquerque, NM); J. Hoehn, J. Kolb, K. Noreen*, N. Goldberg* (Marshfield, Wis); J. Barkun, D. Papamikhael, C. Flemming (Montreal, Quebec); R. J. Fitzgibbons, R. Christian, K. Kaczmarek, C. Marcuzzo*, M. Ricceri*, J. Ortiz, J. Thompson (Omaha, Neb); K. Richards, E. Callaham, S. Ali, S. Thomas*, K. Johnson* (American College of Surgeons); J. Wang, S. Heard, J. Motyka*, C. Sullivan* (Cooperative Studies Program Coordinating Center, Hines, Ill).

Acknowledgment: We thank William Henderson, PhD, University of Colorado Health Outcomes Program, Aurora, for his participation in the design and concept of the study, and we are grateful to C. James Carrico, MD (deceased), Department of Surgery, University of Texas Southwestern, Dallas, for his assistance with obtaining study funding.

JAMA: The Journal of the American Medical Association 295(3):p 285-292, January 18, 2006.

Context

Many men with inguinal hernia have minimal symptoms. Whether deferring surgical repair is a safe and acceptable option has not been assessed.

Objective

To compare pain and the physical component score (PCS) of the Short Form-36 Version 2 survey at 2 years in men with minimally symptomatic inguinal hernias treated with watchful waiting or surgical repair.

Design, Setting, and Participants

Randomized trial conducted January 1, 1999, through December 31, 2004, at 5 North American centers and enrolling 720 men (364 watchful waiting, 356 surgical repair) followed up for 2 to 4.5 years.

Interventions

Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tension-free repair and were followed up at 3 and 6 months and annually.

Main Outcome Measures

Pain and discomfort interfering with usual activities at 2 years and change in PCS from baseline to 2 years. Secondary outcomes were complications, patient-reported pain, functional status, activity levels, and satisfaction with care.

Results

Primary intention-to-treat outcomes were similar at 2 years for watchful waiting vs surgical repair: pain limiting activities (5.1% vs 2.2%, respectively; P = .52); PCS (improvement over baseline, 0.29 points vs 0.13 points; P = .79). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17% assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over improved after repair. Occurrence of postoperative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. One watchful-waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years; a second had acute incarceration with bowel obstruction at 4 years, with a frequency of 1.8/1000 patient-years inclusive of patients followed up for as long as 4.5 years.

Conclusions

Watchful waiting is an acceptable option for men with minimally symptomatic inguinal hernias. Delaying surgical repair until symptoms increase is safe because acute hernia incarcerations occur rarely.

Clinical Trials Registration

ClinicalTrials.gov Identifier: NCT00263250