Preperitoneal Umbilical Mesh Area

Ventral Hernia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576753
• Other study ID #: PUMA
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2023
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Maaike Vierstraete, MD
• Phone: 003292467400
• Email: maaikevierstraete[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Hernia, Ventral
• Incisional Hernia
• Umbilical Hernia
• Ventral Hernia
• Ventral Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Operation duration	Recording of the operation duration needed for robot-assisted ventral TAPP procedure	once during operation
Secondary	Intra-operative complications	Intra-operative complications registered until 4 weeks after the hernia repair	until 4 weeks post-operative
Secondary	Early post-operative complications	Early post-operative complications detected until 30 days after hernia repair	until 30 days post-operative
Secondary	Late complications	Late complications (after 30 days)	After 30 days post-operative
Secondary	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
Secondary	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