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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00478348
• Date of registration: 22/05/2007
• Prospective Registration: No
• Primary sponsor: University of Lausanne Hospitals
• Public title: Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
• Scientific title: Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
• Date of first enrolment: May 2007
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00478348
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Nicolas Demartines, MD
• Affiliation: Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Postoperative Complications

Hernia

Intervention(s)

Procedure: Prosthetic repair of abdominal incisional hernia

Primary Outcome(s)

Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings. [Time Frame: 30 days]

Secondary ID(s)

DP-2007-CHV-UNIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors