NCT01543789

Brief Summary

The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery. This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3.8 years

First QC Date

February 10, 2012

Last Update Submit

July 2, 2024

Conditions

Umbilical Hernia

Keywords

Umbilical Hernia

Outcome Measures

Primary Outcomes (1)

  • Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.

    Time registration of the operating time will be extracted from the hospital electronic patient files.

    Total duration of the operation with an expected average of approximately 45 minutes.

Secondary Outcomes (4)

  • Surgical wound morbidity complication rate.

    Up to 1 year.

  • Recurrence Rate

    up to 2 years

  • Pain evaluation

    within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years

  • Discomfort evaluation.

    Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.

Study Arms (2)

Intraperitoneal mesh placement

EXPERIMENTAL

Mesh placement inside the peritoneal cavity

Procedure: Intraperitoneal mesh placement

Preperitoneal mesh placement

ACTIVE COMPARATOR

Mesh placement between peritoneum and muscle layer.

Procedure: Preperitoneal mesh placement

Interventions

Intraperitoneal mesh placementPROCEDURE

Mesh placement inside the peritoneal cavity.

Intraperitoneal mesh placement
Preperitoneal mesh placementPROCEDURE

Mesh placement between peritoneum and muscle layer.

Preperitoneal mesh placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent from the patient or his/her legal representative
  • primary umbilical hernia requiring elective surgical repair
  • diameter between 0 and 3 cm

You may not qualify if:

  • no written informed consent
  • incisional hernia at the level of the umbilicus
  • recurrent umbilical hernia, as they have to be considered an incisional hernia
  • emergency surgery (incarcerated hernia)
  • pregnancy
  • non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ASZ Aalst

Aalst, 9300, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Links

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Berrevoet, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

March 5, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 31, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(3)