Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

University Hospital Basel

Status and phase: Terminated; Phase 4

Conditions: Umbilical Hernia

Treatments: Procedure: intraperitoneal onlay mesh repair; Procedure: sublay mesh repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01201564

IPOM-46/10

Details and patient eligibility

About

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• informed consent
• patient age: ≥ 18 years
• elective surgery for umbilical hernia
• hernia diameter ≥ 1cm

Exclusion criteria

• previous history of median laparotomy
• navel site infection
• contraindication for general anaesthesia
• American Society of Anesthesiologists (ASA) score >IV
• pregnancy
• cirrhosis of the liver (CHILD B and C) and/or ascites
• cytostatic therapy
• incarcerated hernia
• recurrent hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

intraperitoneal onlay mesh repair

Active Comparator group

Treatment:

Procedure: intraperitoneal onlay mesh repair

sublay mesh repair

Active Comparator group

Treatment:

Procedure: sublay mesh repair