PUMA: Preperitoneal Umbilical Mesh Area

Sponsor
Algemeen Ziekenhuis Maria Middelares (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05576753
Collaborator
(none)
20
1
1
27
0.7

Study Details

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®).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hernia repair
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
One single group of 20 patientsOne single group of 20 patients
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient

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

Procedure: Hernia repair
Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia

Outcome Measures

Primary Outcome Measures

  1. Change of mesh surface (percentage) [1 month and 13 month post-operatively]

    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

  1. Change in mesh surface between implantation surface size [1 month and 13 month post-operatively]

    Change in mesh surface between implantation surface size, surface at 1m and at 13m

  2. Change in mesh width and length between implantation surface size [1 month and 13 month post-operatively]

    Change in mesh width and length between implantation surface size, surface at 1m and at 13m

  3. Operation duration [once during operation]

    Recording of the operation duration needed for robot-assisted ventral TAPP procedure

  4. Intra-operative complications [until 4 weeks post-operative]

    Intra-operative complications registered until 4 weeks after the hernia repair

  5. Early post-operative complications [until 30 days post-operative]

    Early post-operative complications detected until 30 days after hernia repair

  6. Late complications [After 30 days post-operative]

    Late complications (after 30 days)

  7. Quality of Life questionnaire [Preoperatively, 30 days, 13 months]

    Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome

  8. Body image score [Preoperatively, 30 days, 13 months]

    Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AZ Maria Middelares Ghent Belgium 9000

Sponsors and Collaborators

  • Algemeen Ziekenhuis Maria Middelares

Investigators

  • Principal Investigator: Maaike Vierstraete, Algemeen Ziekenhuis Maria Middelares

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maaike Vierstraete, Medical Doctor Department General Surgery, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier:
NCT05576753
Other Study ID Numbers:
  • PUMA
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maaike Vierstraete, Medical Doctor Department General Surgery, Algemeen Ziekenhuis Maria Middelares
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2022