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Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.
JAMA 2006; 295(3):285-92JAMA

Abstract

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 = .06 [corrected]); 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.

Authors+Show Affiliations

Department of Surgery, Creighton University, Omaha, Neb, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16418463

Citation

Fitzgibbons, Robert J., et al. "Watchful Waiting Vs Repair of Inguinal Hernia in Minimally Symptomatic Men: a Randomized Clinical Trial." JAMA, vol. 295, no. 3, 2006, pp. 285-92.
Fitzgibbons RJ, Giobbie-Hurder A, Gibbs JO, et al. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006;295(3):285-92.
Fitzgibbons, R. J., Giobbie-Hurder, A., Gibbs, J. O., Dunlop, D. D., Reda, D. J., McCarthy, M., ... Jonasson, O. (2006). Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA, 295(3), pp. 285-92.
Fitzgibbons RJ, et al. Watchful Waiting Vs Repair of Inguinal Hernia in Minimally Symptomatic Men: a Randomized Clinical Trial. JAMA. 2006 Jan 18;295(3):285-92. PubMed PMID: 16418463.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. AU - Fitzgibbons,Robert J,Jr AU - Giobbie-Hurder,Anita, AU - Gibbs,James O, AU - Dunlop,Dorothy D, AU - Reda,Domenic J, AU - McCarthy,Martin,Jr AU - Neumayer,Leigh A, AU - Barkun,Jeffrey S T, AU - Hoehn,James L, AU - Murphy,Joseph T, AU - Sarosi,George A,Jr AU - Syme,William C, AU - Thompson,Jon S, AU - Wang,Jia, AU - Jonasson,Olga, PY - 2006/1/19/pubmed PY - 2006/1/24/medline PY - 2006/1/19/entrez SP - 285 EP - 92 JF - JAMA JO - JAMA VL - 295 IS - 3 N2 - 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 = .06 [corrected]); 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/16418463/Watchful_waiting_vs_repair_of_inguinal_hernia_in_minimally_symptomatic_men:_a_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.295.3.285 DB - PRIME DP - Unbound Medicine ER -