Abdominal Binder to Reduce Pain and Seroma Formation

Ventral Hernias Clinical Trial

— ABD- BINDER  

Official title:

Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673568
• Other study ID #: AB-BINDER
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: May 21, 2014
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia, Ventral
• Ventral Hernias

Intervention

Device:
• ETO garments
patients wearing abdominal binder for 7 days postoperatively

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre	CPH

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale of Pain Activity	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.	24 hours after hernia repair	No
Secondary	Seroma Formation	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.	postoperative day 7	No