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Abdominal Binder to Reduce Pain and Seroma Formation (ABD- BINDER)

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ClinicalTrials.gov Identifier: NCT01673568
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital

Study Description
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Brief Summary:

Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact, postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation.

Method and material Randomized, controlled, multi-center, investigator-blinded study. A minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power calculations. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. Outcomes are based on patient self-reported registrations using Visual Analog Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For secondary outcome we use ultrasound to measure the volume of seroma formation. We use Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test for pain, discomfort and quality of life for the effect of time on inter- and intragroup differences during the study period. P < 0.05 is considered significant.


Condition or disease Intervention/treatment Phase
Ventral Hernias Device: ETO garments Not Applicable

Detailed Description:
Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Several interventional procedures have been investigated to reduce or avoid postoperative seroma formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum application to the subcutaneous layer, suction etc., but results are conflicting and evidence is of poor quality. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. Randomized, controlled, multi-center, investigator-blinded study supplemented with blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power calculations. An intention to treat analysis is done. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (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 before the operation by waist measurement according to the recommendation from the company. Patients are followed-up for 30 days with clinical follow-up at day 7 and 30.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: abdominal binder
The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (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 before the operation by waist measurement according to the recommendation from the company.
 Device: ETO garments
patients wearing abdominal binder for 7 days postoperatively
Other Names:
  • longuette
  • ostomy belt
  • trusses
  • girdle
No Intervention: no abdominal binder
no abdominal binder


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale of Pain Activity [ Time Frame: 24 hours after hernia repair ]
    Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.


Secondary Outcome Measures :
  1. Seroma Formation [ Time Frame: postoperative day 7 ]
    Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective, primary and recurrent laparoscopic umbilical and epigastric hernia repair with mesh reinforcement
  • Fascia defects 2-8 cm measured preoperatively by the surgeon at the out-patient clinic for umbi/epi
  • Elective, primary and recurrent laparoscopic trocar-site hernia
  • Patients between 18-80 years

Exclusion Criteria:

  • Open ventral hernia repair
  • Expected low compliance (language problems, dementia and abuse etc.)
  • Fascia defects >8 cm at the preoperative clinical examination.
  • Acute operation
  • Chronic pain syndrome
  • Decompensated liver cirrhosis (Child-Pugh B-C)
  • Patients with a stoma
  • If a secondary operation is performed during the hernia repair procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673568


Locations
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Denmark
Hvidovre Hospital
Hvidovre, CPH, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Investigators
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Study Director: Thue Bisgaard, MD University Hospital HVidovre
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mette Willaume Christoffersen, MD, PhD. stud., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01673568    
Other Study ID Numbers: AB-BINDER
First Posted: August 28, 2012    Key Record Dates
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal