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

Incisional Hernia Clinical Trial

— INSAB  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01776775
• Other study ID #: INSAB
• Status: Withdrawn
• Phase: N/A
• First received: January 24, 2013
• Last updated: August 15, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	measured with EQ-5D	on day 30 and 90 postoperatively	No
Other	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	No
Other	Cosmetic result	measured with verbal rating scale	3 months postoperatively	No
Primary	seroma formation	clinically detectable seroma formation	30 days postoperatively	No
Secondary	postoperative pain	Measured with self-registration VAS scales	pain during the postoperative days 1-3, 7, and 30.	No