Abdominal Binder to Reduce Pain and Seroma Formation
Condition: Ventral Hernias
MeSH terms: Hernia; Hernia, Ventral
Study type: Interventional

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.
    

Detailed description: 
      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. Several
      interventional procedures have been investigated to reduce or avoid postoperative seroma
      formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum
      application to the subcutaneous layer, suction etc., but results are conflicting and evidence
      is of poor quality. 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. Randomized, controlled, multi-center, investigator-blinded study supplemented with
      blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power
      calculations. An intention to treat analysis is done. 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. 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. Patients
      are followed-up for 30 days with clinical follow-up at day 7 and 30.
    

Intervention name(s): ETO garments
Intervention type(s): Device
Intervention description(s): patients wearing abdominal binder for 7 days postoperatively
Other intervention name(s): longuette; ostomy belt; trusses; girdle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention