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The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms.
J Am Coll Surg 2003; 196(5):737-42JA

Abstract

BACKGROUND

This article describes the development and implementation of a randomized clinical trial designed to answer the question: Is watchful waiting an acceptable alternative to operation for men with asymptomatic or minimally symptomatic inguinal hernias?

STUDY DESIGN

A clinical trial has been designed to compare watchful waiting and operation for men with an asymptomatic or a relatively asymptomatic inguinal hernia. Men are randomized to watchful waiting or a standard open operation, the Lichtenstein tension-free hernia repair, and are followed for a minimum of 2 years. The target sample size of 753 patients was chosen so that the trial would have power sufficiently high to detect a clinically meaningful difference between treatment groups in either of the two primary outcomes as measured at 2 years: pain or discomfort interfering with normal activities and the physical component summary score of the SF-36 health-related quality-of-life survey. The study was begun in five centers located in both community and academic environments. At 18 months, a sixth site was added and at 28 months, after enrollment of 145 patients, one of the centers was terminated for reasons related to inadequate followup; all data from this center were deleted. As a routine measure, an independent experienced trial manager audited all clinical sites.

RESULTS

Enrollment of patients began in January 2000 and will end on December 31, 2002. As of November 1, 2002, 637 patients had been randomized, 85% of the target enrollment. An additional 2,115 patients were screened but not randomized, yielding a recruitment rate of 23.1%. Analysis and publication of the results of the study will take place on completion of the minimum 2-year followup period for all patients.

CONCLUSIONS

A trial to compare the outcomes of watchful waiting and operation for management of inguinal hernias in men is needed to provide data to surgeons and to patients that can aid in choice of treatment. A description of the design of such a trial is presented.

Authors+Show Affiliations

Creighton University Department of Surgery, Omaha, NE 68131, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

12742207

Citation

Fitzgibbons, Robert J., et al. "The Development of a Clinical Trial to Determine if Watchful Waiting Is an Acceptable Alternative to Routine Herniorrhaphy for Patients With Minimal or No Hernia Symptoms." Journal of the American College of Surgeons, vol. 196, no. 5, 2003, pp. 737-42.
Fitzgibbons RJ, Jonasson O, Gibbs J, et al. The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms. J Am Coll Surg. 2003;196(5):737-42.
Fitzgibbons, R. J., Jonasson, O., Gibbs, J., Dunlop, D. D., Henderson, W., Reda, D., ... McCarthy, M. (2003). The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms. Journal of the American College of Surgeons, 196(5), pp. 737-42.
Fitzgibbons RJ, et al. The Development of a Clinical Trial to Determine if Watchful Waiting Is an Acceptable Alternative to Routine Herniorrhaphy for Patients With Minimal or No Hernia Symptoms. J Am Coll Surg. 2003;196(5):737-42. PubMed PMID: 12742207.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms. AU - Fitzgibbons,Robert J, AU - Jonasson,Olga, AU - Gibbs,James, AU - Dunlop,Dorothy D, AU - Henderson,William, AU - Reda,Domenic, AU - Giobbie-Hurder,Anita, AU - McCarthy,Martin, PY - 2003/5/14/pubmed PY - 2003/6/5/medline PY - 2003/5/14/entrez SP - 737 EP - 42 JF - Journal of the American College of Surgeons JO - J. Am. Coll. Surg. VL - 196 IS - 5 N2 - BACKGROUND: This article describes the development and implementation of a randomized clinical trial designed to answer the question: Is watchful waiting an acceptable alternative to operation for men with asymptomatic or minimally symptomatic inguinal hernias? STUDY DESIGN: A clinical trial has been designed to compare watchful waiting and operation for men with an asymptomatic or a relatively asymptomatic inguinal hernia. Men are randomized to watchful waiting or a standard open operation, the Lichtenstein tension-free hernia repair, and are followed for a minimum of 2 years. The target sample size of 753 patients was chosen so that the trial would have power sufficiently high to detect a clinically meaningful difference between treatment groups in either of the two primary outcomes as measured at 2 years: pain or discomfort interfering with normal activities and the physical component summary score of the SF-36 health-related quality-of-life survey. The study was begun in five centers located in both community and academic environments. At 18 months, a sixth site was added and at 28 months, after enrollment of 145 patients, one of the centers was terminated for reasons related to inadequate followup; all data from this center were deleted. As a routine measure, an independent experienced trial manager audited all clinical sites. RESULTS: Enrollment of patients began in January 2000 and will end on December 31, 2002. As of November 1, 2002, 637 patients had been randomized, 85% of the target enrollment. An additional 2,115 patients were screened but not randomized, yielding a recruitment rate of 23.1%. Analysis and publication of the results of the study will take place on completion of the minimum 2-year followup period for all patients. CONCLUSIONS: A trial to compare the outcomes of watchful waiting and operation for management of inguinal hernias in men is needed to provide data to surgeons and to patients that can aid in choice of treatment. A description of the design of such a trial is presented. SN - 1072-7515 UR - https://www.unboundmedicine.com/medline/citation/12742207/The_development_of_a_clinical_trial_to_determine_if_watchful_waiting_is_an_acceptable_alternative_to_routine_herniorrhaphy_for_patients_with_minimal_or_no_hernia_symptoms_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1072-7515(03)00003-6 DB - PRIME DP - Unbound Medicine ER -