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

The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.

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.

Study Overview

• Status: Withdrawn
• Conditions: Incisional Hernia
• Intervention / Treatment: Device: Abdominal binder

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: abdominal binder; use of postoperative abdominal binder 30 days after the hernia repair	Device: 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.; Other Names: longuette; ostomy belt; trusses; girdle; ETO garments©; abdominal belt
NO_INTERVENTION: No abdominal binder; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seroma formation	clinically detectable seroma formation	30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Measured with self-registration VAS scales	pain during the postoperative days 1-3, 7, and 30.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	measured with EQ-5D	on day 30 and 90 postoperatively
postoperative complications, readmittance, and need for general practitioner visits	30-day complications will be registered by patient interview and by cross-checking patient files and the Danish national patient registry	30 days postoperatively
Cosmetic result	measured with verbal rating scale	3 months postoperatively

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Director: Thue Bisgaard, DMSc, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (ESTIMATE): January 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: INSAB