The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair

NCT ID: NCT01776775

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-08-31

Brief Summary

Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.

Conditions

Incisional Hernia

Study Design

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

Study Groups

abdominal binder

use of postoperative abdominal binder 30 days after the hernia repair

Group Type: ACTIVE_COMPARATOR

Abdominal binder

Intervention Type: DEVICE

The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (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 for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position.

No abdominal binder

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Abdominal binder

The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (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 for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position.

Intervention Type: DEVICE

Other Intervention Names

ETO garments©; ostomy belt; trusses; girdle; longuette; abdominal belt

Eligibility Criteria

Inclusion Criteria

• elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement
• fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic
• patients between 18-80 years

Exclusion Criteria

• expected low compliance (language problems, dementia and abuse etc.)
• fascia defects >20 cm measured at the preoperative clinical examination.
• acute operation
• decompensated liver cirrhosis (Child-Pugh 3-4)
• patients with a stoma
• if a secondary operation is performed during the hernia repair procedure.
• if a patient withdraws his inclusion consent

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

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette Willaume Christoffersen

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thue Bisgaard, DMSc

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

INSAB

Identifier Type: -

Identifier Source: org_study_id