Skip to main content
Clinical Trials/NCT01776775
NCT01776775WithdrawnNot Applicable

The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.

Hvidovre University Hospital2 sites in 1 countryStarted: January 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
seroma formation

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

seroma formation

Time Frame: 30 days postoperatively

clinically detectable seroma formation

Secondary Outcomes

  • postoperative pain(pain during the postoperative days 1-3, 7, and 30.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mette Willaume Christoffersen

M.D

Hvidovre University Hospital

Study Sites (2)

Loading locations...

Similar Trials