Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?

Not Applicable

Completed

• Conditions: Hernia; Postoperative Complications
• Interventions: Procedure: Prosthetic repair of abdominal incisional hernia

• Registration Number: NCT00478348
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.

Detailed Description

Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.

Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.

Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.

In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.

The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-24
• Primary Completion: 2017-10-01
• Status Verified: 2017-11
• Study Completion: 2017-11-10
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Clinical diagnosis of midline abdominal wall incisional hernia
• Adults of 20 to 80 years old
• ASA I to III
• Inform consent signed by the patient and investigators

Exclusion Criteria

• Incisional hernia less than 2 cm
• Groin hernia
• Antibiotic treatment before and during hospital admission
• Emergency admission for strangulated incisional hernia
• Immunosuppressing treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No drain	Prosthetic repair of abdominal incisional hernia	-
Drain	Prosthetic repair of abdominal incisional hernia	-

Primary Outcome Measures

Name	Time	Method
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.	30 days

Trial Locations

Locations (1)

Department of Visceral Surgery, University Hospital Center; 🇨🇭 Lausanne, Vaud, Switzerland