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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478348
• Other study ID #: DP-2007-CHV-UNIL
• Status: Completed
• Phase: N/A
• First received: May 22, 2007
• Last updated: November 14, 2017
• Start date: May 2007
• Est. completion date: November 10, 2017

Study information

• Verified date: November 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 10, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Incisional Hernia
• Postoperative Complications

Intervention

Procedure:
• Prosthetic repair of abdominal incisional hernia
Rives-Stoppa repair of incisional hernia

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery, University Hospital Center	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.		30 days