Abdominal Binder to Reduce Pain and Seroma Formation

NCT ID: NCT01673568

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-09-30

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.

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.

Conditions

Ventral Hernias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ETO garments

Intervention Type: DEVICE

patients wearing abdominal binder for 7 days postoperatively

no abdominal binder

no abdominal binder

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ETO garments

patients wearing abdominal binder for 7 days postoperatively

Intervention Type: DEVICE

Other Intervention Names

longuette; ostomy belt; trusses; girdle

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette Willaume Christoffersen

MD, PhD. stud.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thue Bisgaard, MD

Role: STUDY_DIRECTOR

University Hospital HVidovre

Locations

Hvidovre Hospital

Hvidovre, CPH, Denmark

Countries

Denmark

Other Identifiers

AB-BINDER

Identifier Type: -

Identifier Source: org_study_id