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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:
Sponsor: Hvidovre University Hospital

Current Primary Outcome: seroma formation [ Time Frame: 30 days postoperatively ]

clinically detectable seroma formation


Original Primary Outcome: Pain [ Time Frame: 1. and 2. postoperative day ]

measured with VAS on day 1-3 postoperatively selfregistration


Current Secondary Outcome: postoperative pain [ Time Frame: pain during the postoperative days 1-3, 7, and 30. ]

Measured with self-registration VAS scales


Original Secondary Outcome: seroma [ Time Frame: 7th postoperative day ]

Measured with transabdominal ultrasound by an experienced expert radiologist


Information By: Hvidovre University Hospital

Dates:
Date Received: January 24, 2013
Date Started: January 2016
Date Completion:
Last Updated: August 15, 2016
Last Verified: August 2016