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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01776775
First received: January 24, 2013
Last updated: April 24, 2014
Last verified: April 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 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.


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:
  • seroma formation [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
    clinically detectable seroma formation


Secondary Outcome Measures:
  • postoperative pain [ Time Frame: pain during the postoperative days 1-3, 7, and 30. ] [ Designated as safety issue: No ]
    Measured with self-registration VAS scales


Other Outcome Measures:
  • Quality of life [ Time Frame: on day 30 and 90 postoperatively ] [ Designated as safety issue: No ]
    measured with EQ-5D

  • postoperative complications, readmittance, and need for general practitioner visits [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
    30-day complications will be registered by patient interview and by cross-checking patient files and the Danish national patient registry


Estimated Enrollment: 60
Study Start Date: May 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: abdominal binder
use of postoperative abdominal binder 30 days after the hernia repair
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Mette W Christoffersen, M.D. +4526288934 mette.willaume@gmail.com
Contact: Thue Bisgaard, DMSc +45 26110021 thue.bisgaard@gmail.com

Locations
Denmark
Hvidovre University Hospital Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Mette w Christoffersen, MD    +4526288934    mette.willaume@gmail.com   
Contact: Thue Bisgaard, DMSc    +45 26110021    thue.bisgard@gmail.com   
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Thue Bisgaard, DMSc 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: INSAB
Study First Received: January 24, 2013
Last Updated: April 24, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014