Visible vs. Non-Visible Mesh in Underlay Positon After Repair of Umbilical Hernias

NCT03200405 | Completed

• 1 other identifier: Dietz_87/16-sc
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the exact position of a mesh which is placed in underlay position in umbilical hernia in vitro. The investigators want to gain information if the mesh lays directly next to the abdominal wall fascia or if there´s fat tissue between mesh and fascia. Furthermore they hope to get some information about the tissue incorporation.

Conditions

Umbilical Hernia

Keywords

umbilical hernia; mesh repair; MRI-visibility; underlay; NANEP; DynaMeshCICAT; DynaMeshVisible; preperitoneal

Outcome Measures

Primary Outcomes (1)

• MRI visibility and visible size of the mesh 4 weeks after operation

  A MRI will be done 4 weeks after the operation and it will be registered if the mesh is visible; furthermore there will be done some measurements to specify the exact position and the visible size of the mesh

  4 weeks

Secondary Outcomes (4)

• MRI visibility and visible size of the mesh 12 months after operation

  12 months

• intraoperative and postoperative complications (30-day morbidity)

  4 weeks

• relapse 12 months after operation

  12 months

• life quality 4 weeks and 12 months after operation

  12 months

Study Arms (2)

DynaMeshVisible

EXPERIMENTAL

the umbilical hernia will be fixed with a mesh, which is incorporated with Fe3O4 particles to become visible in MRI

Device: DynaMeshVisible

DynaMeshCICAT

ACTIVE COMPARATOR

the umbilical hernia will be fixed with a Non-MRI-visible PVDF Mesh

Device: DynaMeshCICAT

Interventions

DynaMeshVisible DEVICE

The umbilical hernias will be fixed with a mesh. In this group a MRI-visible mesh will be used.

DynaMeshVisible

DynaMeshCICAT DEVICE

The umbilical hernias will be fixed with a mesh. In this group a non-visible mesh will be used.

DynaMeshCICAT

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• umbilical hernia \> 0,4 cm; \<= 3 cm
• BMI \> 20; \< 51

You may not qualify if:

• emergency operation
• previous abdominal operation
• epigastric hernia in more than 3 cm distance of the umbilical hernia
• ascites
• hepatic insufficiency
• periumbilical skin disease
• incisional umbilical hernia
• claustrophobia
• contraindications concerning the MRI examination

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Universitätsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrich Dietz, Prof Dr Dr

  Wuerzburg UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 27, 2017
• Study Start: October 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)