Abdominal Binder to Reduce Pain and Seroma Formation
Abdominal Binder to Reduce Pain and Seroma Formation
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.
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.
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