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

Not Applicable

Withdrawn

• Conditions: Incisional Hernia
• Interventions: Device: Abdominal binder

• Registration Number: NCT01776775
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Study Start: 2016-01
• Primary Completion: 2016-07
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abdominal binder	Abdominal binder	use of postoperative abdominal binder 30 days after the hernia repair

Primary Outcome Measures

Name	Time	Method
seroma formation	30 days postoperatively	clinically detectable seroma formation

Secondary Outcome Measures

Name	Time	Method
postoperative pain	pain during the postoperative days 1-3, 7, and 30.	Measured with self-registration VAS scales

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark