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

NCT01201564 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2019-05-07

No results posted yet for this study

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.

Conditions

  • Umbilical Hernia

Interventions

PROCEDURE

intraperitoneal onlay mesh repair

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 des rectus muscle after small incision close to the belly button.

PROCEDURE

sublay mesh repair

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 des rectus muscle after small incision close to the belly button.

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Daniel Oertli, Professor · Departement of General Surgery, University Hospital Basel, Switzerland

  • Oleg Heizmann, MD · Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

  • Daniel Matz, MD · Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201564 on ClinicalTrials.gov