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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.

Conditions
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Postoperative Complications, Hernia

Intervention / Treatment
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* Procedure: Prosthetic repair of abdominal incisional hernia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Drain<br> | Procedure: Prosthetic repair of abdominal incisional hernia<br>* Rives-Stoppa repair of incisional hernia<br>|
| Other: No drain<br> | Procedure: Prosthetic repair of abdominal incisional hernia<br>* Rives-Stoppa repair of incisional hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Complications, Drainage, Infection, Seroma, Hematoma, Recurrence, Abdominal Wall, Hernia, Surgical Mesh