Preperitoneal Umbilical Mesh Area (PUMA)

Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Preperitoneal Mesh Repair Using an Iron Oxide Loaded PVDF Mesh

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®).

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia; Umbilical Hernia; Ventral Incisional Hernia
• Intervention / Treatment: Procedure: Hernia repair

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maaike Vierstraete, MD; Phone Number: 003292467400; Email: maaikevierstraete@icloud.com
• Study Contact Backup: Name: Filip Muysoms, MD; Phone Number: 003282467400; Email: filip.muysoms@azmmsj.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
    • Contact: Maaike Vierstraete, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 month and 13 month post-operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Maaike Vierstraete, Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mesh shrinkage; Abdominal wall surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia; Hernia, Umbilical
• Other Study ID Numbers: PUMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No