Abdominal Binder to Reduce Pain and Seroma Formation

NCT01673568 | Completed Results

• 1 other identifier: AB-BINDER
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernias

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Seroma Formation

  postoperative day 7

Study Arms (2)

abdominal binder

ACTIVE COMPARATOR

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

no abdominal binder

NO INTERVENTION

no abdominal binder

Interventions

ETO garments DEVICE

patients wearing abdominal binder for 7 days postoperatively

Also known as: longuette, ostomy belt, trusses, girdle

abdominal binder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, CPH, 2650, Denmark

Location

MeSH Terms

Conditions

Hernia, Ventral

Interventions

Trusses

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Mette W. Christoffersen
• Organization: Hvidovre Hospital University of Copenhagen

mette.willaume@gmail.com

38625826

Study Officials

• Thue Bisgaard, MD

  University Hospital HVidovre

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. stud.

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: August 28, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

DK (1)