CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
ETO garmentsdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01673568
NCT01673568N/ACompleted

Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.

Hvidovre University Hospital·interventional·Posted Aug 28, 2012·Updated Jun 9, 2014

In Brief

A clinical study evaluating ETO garments for Ventral Hernias. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact, postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. Method and material Randomized, controlled, multi-center, investigator-blinded study. A minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power calculations. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. Outcomes are based on patient self-reported registrations using Visual Analog Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For secondary outcome we use ultrasound to measure the volume of seroma formation. We use Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test for pain, discomfort and quality of life for the effect of time on inter- and intragroup differences during the study period. P \< 0.05 is considered significant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentral Hernias
CountriesDenmark

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2012
Enrollment StartOct 1, 2012
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.8 years ago

Interventions

ETO garmentsdevice

patients wearing abdominal binder for 7 days postoperatively