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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01776775
Recruitment Status : Withdrawn (due to lack of finace)
First Posted : January 28, 2013
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
seroma formation [ Time Frame: 30 days postoperatively ]
clinically detectable seroma formation
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
Pain [ Time Frame: 1. and 2. postoperative day ]
measured with VAS on day 1-3 postoperatively selfregistration
Change History Complete list of historical versions of study NCT01776775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
postoperative pain [ Time Frame: pain during the postoperative days 1-3, 7, and 30. ]
Measured with self-registration VAS scales
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
seroma [ Time Frame: 7th postoperative day ]
Measured with transabdominal ultrasound by an experienced expert radiologist
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2015)
  • Quality of life [ Time Frame: on day 30 and 90 postoperatively ]
    measured with EQ-5D
  • postoperative complications, readmittance, and need for general practitioner visits [ Time Frame: 30 days postoperatively ]
    30-day complications will be registered by patient interview and by cross-checking patient files and the Danish national patient registry
  • Cosmetic result [ Time Frame: 3 months postoperatively ]
    measured with verbal rating scale
Original Other Pre-specified Outcome Measures
 (submitted: January 25, 2013)
Quality of life [ Time Frame: on day 7 and 30 postoperatively ]
measured with Carolina Comfort Scale
 
Descriptive Information
Brief Title  ICMJE The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair
Official Title  ICMJE The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Incisional Hernia
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: abdominal binder
    use of postoperative abdominal binder 30 days after the hernia repair
    Intervention: Device: Abdominal binder
  • No Intervention: No abdominal binder
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 15, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2013)
52
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776775
Other Study ID Numbers  ICMJE INSAB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mette Willaume Christoffersen, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thue Bisgaard, DMSc Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP