search
Back to results

Preperitoneal Umbilical Mesh Area (PUMA)

Primary Purpose

Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hernia repair
Sponsored by
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring Mesh shrinkage, Abdominal wall surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary umbilical hernias up to 2 cm
  • Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm

Exclusion Criteria:

  • <18 years
  • Emergency surgery (incarcerated hernia)
  • Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
  • Lateral hernias
  • Hernias close to the sternum or the pubic bone
  • Hernias bigger than 2 cm in diameter.
  • Hernias that need a component separation technique.
  • Previous mesh repair on the midline
  • ASA score> 4
  • Pregnancy
  • No patient Informed Consent
  • Life expectancy of less than 2years
  • Contraindications for MRI

Sites / Locations

  • AZ Maria MiddelaresRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient

Arm Description

Patients scheduled for robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia

Outcomes

Primary Outcome Measures

Change of mesh surface (percentage)
Shrinkage rate / change of the mesh surface (percentage) as measured with the MRI between 1 month and 13 months postoperatively, defined as (100 - mesh surface at 13 months x 100 / mesh surface at 1 month)

Secondary Outcome Measures

Change in mesh surface between implantation surface size
Change in mesh surface between implantation surface size, surface at 1m and at 13m
Change in mesh width and length between implantation surface size
Change in mesh width and length between implantation surface size, surface at 1m and at 13m
Operation duration
Recording of the operation duration needed for robot-assisted ventral TAPP procedure
Intra-operative complications
Intra-operative complications registered until 4 weeks after the hernia repair
Early post-operative complications
Early post-operative complications detected until 30 days after hernia repair
Late complications
Late complications (after 30 days)
Quality of Life questionnaire
Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome
Body image score
Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).

Full Information

First Posted
September 25, 2022
Last Updated
March 18, 2023
Sponsor
Algemeen Ziekenhuis Maria Middelares
search

1. Study Identification

Unique Protocol Identification Number
NCT05576753
Brief Title
Preperitoneal Umbilical Mesh Area
Acronym
PUMA
Official Title
Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Preperitoneal Mesh Repair Using an Iron Oxide Loaded PVDF Mesh
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to measure the mesh shrinkage and the visualization of the mesh with MRI scan at 1 month and 13 months after robot assisted preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).
Detailed Description
The study will be conducted in the department of surgery in het AZ Maria Middelares, Ghent, Belgium. Dr. Filip Muysoms will personally select and operate all patients eligible for this study. He will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers will perform all MRI examinations of the patients at 1 month and 13 months post-operatively and will be available for questions from the patient. We want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh in a safe manner. Furthermore, the positioning of the mesh, mesh shrinkage or mesh shifting will be monitored with this technique. This provides long-term benefit and provides early treatment possibilities in case of post-operative complications related to the mesh position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia
Keywords
Mesh shrinkage, Abdominal wall surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One single group of 20 patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
Patients scheduled for robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia
Intervention Type
Procedure
Intervention Name(s)
Hernia repair
Intervention Description
Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia
Primary Outcome Measure Information:
Title
Change of mesh surface (percentage)
Description
Shrinkage rate / change of the mesh surface (percentage) as measured with the MRI between 1 month and 13 months postoperatively, defined as (100 - mesh surface at 13 months x 100 / mesh surface at 1 month)
Time Frame
1 month and 13 month post-operatively
Secondary Outcome Measure Information:
Title
Change in mesh surface between implantation surface size
Description
Change in mesh surface between implantation surface size, surface at 1m and at 13m
Time Frame
1 month and 13 month post-operatively
Title
Change in mesh width and length between implantation surface size
Description
Change in mesh width and length between implantation surface size, surface at 1m and at 13m
Time Frame
1 month and 13 month post-operatively
Title
Operation duration
Description
Recording of the operation duration needed for robot-assisted ventral TAPP procedure
Time Frame
once during operation
Title
Intra-operative complications
Description
Intra-operative complications registered until 4 weeks after the hernia repair
Time Frame
until 4 weeks post-operative
Title
Early post-operative complications
Description
Early post-operative complications detected until 30 days after hernia repair
Time Frame
until 30 days post-operative
Title
Late complications
Description
Late complications (after 30 days)
Time Frame
After 30 days post-operative
Title
Quality of Life questionnaire
Description
Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome
Time Frame
Preoperatively, 30 days, 13 months
Title
Body image score
Description
Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).
Time Frame
Preoperatively, 30 days, 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary umbilical hernias up to 2 cm Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm Exclusion Criteria: <18 years Emergency surgery (incarcerated hernia) Clean-contaminated, contaminated or dirty procedures (according to the CDC classification) Lateral hernias Hernias close to the sternum or the pubic bone Hernias bigger than 2 cm in diameter. Hernias that need a component separation technique. Previous mesh repair on the midline ASA score> 4 Pregnancy No patient Informed Consent Life expectancy of less than 2years Contraindications for MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maaike Vierstraete, MD
Phone
003292467400
Email
maaikevierstraete@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Filip Muysoms, MD
Phone
003282467400
Email
filip.muysoms@azmmsj.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maaike Vierstraete
Organizational Affiliation
Algemeen Ziekenhuis Maria Middelares
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maaike Vierstraete, MD

12. IPD Sharing Statement

Learn more about this trial

Preperitoneal Umbilical Mesh Area

We'll reach out to this number within 24 hrs