The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair (INSAB)

H

Hvidovre University Hospital

Status

Withdrawn

Conditions

Incisional Hernia

Treatments

Device: Abdominal binder

Study type

Interventional

Funder types

Other

Identifiers

NCT01776775
INSAB

Details and patient eligibility

About

Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement
  • fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic
  • patients between 18-80 years

Exclusion criteria

  • expected low compliance (language problems, dementia and abuse etc.)
  • fascia defects >20 cm measured at the preoperative clinical examination.
  • acute operation
  • decompensated liver cirrhosis (Child-Pugh 3-4)
  • patients with a stoma
  • if a secondary operation is performed during the hernia repair procedure.
  • if a patient withdraws his inclusion consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

abdominal binder
Active Comparator group
Description:
use of postoperative abdominal binder 30 days after the hernia repair
Treatment:
Device: Abdominal binder
No abdominal binder
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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