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Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial.
Trials 2012; 13:14T

Abstract

BACKGROUND

Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia.

METHODS/DESIGN

This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial.

DISCUSSION

To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14th, 2011. An initiation meeting took place in Berlin January 9th, 2012.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT01349400.

Authors+Show Affiliations

Department of General, Vascular, and Thoracic Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany. johannes.lauscher@charite.de

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22314130

Citation

Lauscher, Johannes C., et al. "Development of a Clinical Trial to Determine Whether Watchful Waiting Is an Acceptable Alternative to Surgical Repair for Patients With Oligosymptomatic Incisional Hernia: Study Protocol for a Randomized Controlled Trial." Trials, vol. 13, 2012, p. 14.
Lauscher JC, Martus P, Stroux A, et al. Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial. Trials. 2012;13:14.
Lauscher, J. C., Martus, P., Stroux, A., Neudecker, J., Behrens, U., Hammerich, R., ... Ritz, J. P. (2012). Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial. Trials, 13, p. 14. doi:10.1186/1745-6215-13-14.
Lauscher JC, et al. Development of a Clinical Trial to Determine Whether Watchful Waiting Is an Acceptable Alternative to Surgical Repair for Patients With Oligosymptomatic Incisional Hernia: Study Protocol for a Randomized Controlled Trial. Trials. 2012 Feb 7;13:14. PubMed PMID: 22314130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial. AU - Lauscher,Johannes C, AU - Martus,Peter, AU - Stroux,Andrea, AU - Neudecker,Jens, AU - Behrens,Uwe, AU - Hammerich,Ralf, AU - Buhr,Heinz J, AU - Ritz,Jörg-Peter, Y1 - 2012/02/07/ PY - 2011/09/01/received PY - 2012/02/07/accepted PY - 2012/2/9/entrez PY - 2012/2/9/pubmed PY - 2012/5/16/medline SP - 14 EP - 14 JF - Trials JO - Trials VL - 13 N2 - BACKGROUND: Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia. METHODS/DESIGN: This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial. DISCUSSION: To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14th, 2011. An initiation meeting took place in Berlin January 9th, 2012. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01349400. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/22314130/Development_of_a_clinical_trial_to_determine_whether_watchful_waiting_is_an_acceptable_alternative_to_surgical_repair_for_patients_with_oligosymptomatic_incisional_hernia:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-14 DB - PRIME DP - Unbound Medicine ER -