Abdominal Binder to Reduce Pain and Seroma Formation
ABD- BINDER
Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.
Sponsor study identifier
interventional
56
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 4, 2012
Actual (reported)August 28, 2012
Actual (reported)October 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 2013
Actual (reported)September 2013
Actual (reported)June 9, 2014
Actual (reported)Visual Analog Scale of Pain Activity
Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.
24 hours after hernia repair
Seroma Formation
postoperative day 7
The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
no abdominal binder
patients wearing abdominal binder for 7 days postoperatively
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hvidovre Hospital
Hvidovre, CPH, 2650, Denmark
Thue Bisgaard, MD
University Hospital HVidovre
56 participants (actual enrollment reported by the registry).
First Submitted
July 4, 2012
First Posted
August 28, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
June 9, 2014
Results First Posted
June 9, 2014
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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