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

Phase 4

Terminated

• Conditions: Umbilical Hernia

• Registration Number: NCT01201564
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
early wound complications	30 days after operation	* wound infection (with or without removal of the mesh); * wound necrosis; * wound hematoma
late wound complications	1 year after operation	* wound infection (with or without removal of the mesh); * wound necrosis; * wound hematoma

Secondary Outcome Measures

Name	Time	Method
hospital stay	will be measured after discharge of the patient	measured in days
complication rate postoperative	5 years	* trocar site hernia; * enteral fistula; * persistent pain; * re-operation
navel site seroma	after 1 year	the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
pain score (Visual Analog Scale - VAS)	immediately before discharge	will be measured by the nurse according to Visual Analog Scale
complication rate perioperative	intraoperative complications will be recorded immediately after finishing the operation	* major bleeding; * bowel injury
duration of operation	the duration will be recorded immediately after finishing the operation	measured in minutes according to operations protocol (duration cut - suture)
umbilical hernia recurrence rate	5 years	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Quality of life (SF-36)	1 year postoperatively	patients will be asked to fulfill validated SF-36 questionnaire

Trial Locations

Locations (3)

Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH; 🇩🇪 Rotenburg, Niedersachsen, Germany

University Hospital Basel; 🇨🇭 Basel, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland