The Effect of Postoperative Abdominal Binder to Improve Early Clinical Outcome After Incisional Hernia Repair (INCIS-AB)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01776775
First received: January 24, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 self-registrations with VAS and Carolina Comfort Scale and clinical examination for seroma, recurrence and other complications. Patients are followed until 1 month after the operation.


Condition Intervention
Incisional Hernia
Device: Abdominal binder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) pain score [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    postoperative pain measured with VAS on day 1-3 postoperatively self-registration


Secondary Outcome Measures:
  • seroma [ Time Frame: 7th postoperative day ] [ Designated as safety issue: No ]
    Measured by clinical examination


Other Outcome Measures:
  • Quality of life [ Time Frame: on day 7 and 30 postoperatively ] [ Designated as safety issue: No ]
    measured with Carolina Comfort Scale


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: abdominal binder
use of postoperative abdominal binder 7 days after operation
Device: Abdominal binder
The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (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 for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position.
Other Names:
  • ETO garments©
  • ostomy belt
  • trusses
  • girdle
  • longuette
  • abdominal belt
No Intervention: No abdominal binder
No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • · Elective, primary and recurrent laparoscopic incisional hernia repair hernia with mesh reinforcement

    • Fascia defects 4-20 cm measured preoperatively by the surgeon at the out-patient clinic
    • Midline incisional hernias
    • Patients between 18-80 years
    • Patients' remains included even though complications or lack of use of the AB occurs.

Exclusion Criteria:

Open hernia repair Expected low compliance (language problems, dementia and abuse etc.) Fascia defects >20 cm measured at the preoperative clinical examination. Acute operation Chronic pain syndrome Decompensated liver cirrhosis (Child-Pugh 3-4) Patients with a stoma Deviation from the standardized pre- or postoperative medication regimen. If a secondary operation is performed during the hernia repair procedure. Conversion to open operation If a patient withdraws his inclusion consent

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776775

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Mette W Christoffersen, M.D. Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Mette Willaume Christoffersen, M.D, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01776775     History of Changes
Other Study ID Numbers: AB-BINDER INCIS
Study First Received: January 24, 2013
Last Updated: February 19, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014