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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00478348
Enrollment
200
Registered
2007-05-24
Start date
2007-05-31
Completion date
2017-11-10
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Postoperative Complications

Keywords

Postoperative Complications, Drainage, Infection, Seroma, Hematoma, Recurrence, Abdominal Wall, Hernia, Surgical Mesh

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.

Interventions

PROCEDUREProsthetic repair of abdominal incisional hernia

Rives-Stoppa repair of incisional hernia

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026