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N/A N=56 Randomized Single-blind Prevention

Abdominal Binder to Reduce Pain and Seroma Formation

Ventral Hernias

Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Visual Analog Scale of Pain Activity — 50; 70 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ETO garments (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hvidovre University Hospital
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Scale of Pain Activity
50; 70
SECONDARY
Seroma Formation
7; 9

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.

Eligibility Criteria

Inclusion Criteria

  • Elective, primary and recurrent laparoscopic umbilical and epigastric hernia repair with mesh reinforcement
  • Fascia defects 2-8 cm measured preoperatively by the surgeon at the out-patient clinic for umbi/epi
  • Elective, primary and recurrent laparoscopic trocar-site hernia
  • Patients between 18-80 years

Exclusion Criteria

  • Open ventral hernia repair
  • Expected low compliance (language problems, dementia and abuse etc.)
  • Fascia defects >8 cm at the preoperative clinical examination.
  • Acute operation
  • Chronic pain syndrome
  • Decompensated liver cirrhosis (Child-Pugh B-C)
  • Patients with a stoma
  • If a secondary operation is performed during the hernia repair procedure
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01673568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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