Abdominal Binder to Reduce Seroma Formation and Pain (SEROMA)

This study has been completed.
Sponsor:
Collaborator:
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01673568
First received: July 4, 2012
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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. 60 patients (2X30 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 Intervention
Ventral Hernias
Device: ETO garments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • pain [ Time Frame: 1th postoperative day ] [ Designated as safety issue: No ]
    Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS).


Secondary Outcome Measures:
  • seroma formation, fatigue, generel well-being, quality of life, movement limitations, and pain on day2,3,7 and 30. [ Time Frame: postoperative day 7 ] [ Designated as safety issue: No ]

    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.

    Other outcomes are measured with VAS and Carolina Comfort scale



Enrollment: 54
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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). 60 patients (2 x 30, 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.

  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 umbilical and epigastric hernia repair with mesh reinforcement
  • Fascia defects 2-15 cm measured preoperatively by the surgeon at the out-patient clinic for umbi/epi
  • Elective, primary and recurrent laparoscopic trocar-site hernia
  • Patients between 18-75 years

Exclusion Criteria:

  • Open ventral hernia repair
  • Expected low compliance (language problems, dementia and abuse etc.)
  • Fascia defects >15 cm at the preoperative clinical examination.
  • Acute operation
  • Chronic pain syndrome
  • Decompensated liver cirrhosis (Child-Pugh 3-4)
  • Patients with a stoma
  • If a secondary operation is performed during the hernia repair procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673568

Locations
Denmark
Hvidovre Hospital
Hvidovre, CPH, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Investigators
Study Director: Thue Bisgaard, MD University Hospital HVidovre
  More Information

No publications provided

Responsible Party: Mette Willaume Christoffersen, MD, PhD. stud., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01673568     History of Changes
Other Study ID Numbers: 123-SEROMA
Study First Received: July 4, 2012
Last Updated: December 23, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 17, 2014