NCT05576753

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®).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 25, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

September 25, 2022

Last Update Submit

March 18, 2023

Conditions

Ventral HerniaUmbilical HerniaVentral Incisional Hernia

Keywords

Mesh shrinkageAbdominal wall surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in mesh surface between implantation surface size

    1 month and 13 month post-operatively

  • Change in mesh width and length between implantation surface size

    1 month and 13 month post-operatively

  • Operation duration

    once during operation

  • Intra-operative complications

    until 4 weeks post-operative

  • Early post-operative complications

    until 30 days post-operative

  • +3 more secondary outcomes

Study Arms (1)

Patient

EXPERIMENTAL

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

Procedure: Hernia repair

Interventions

Hernia repairPROCEDURE

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

Patient

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Hernia, VentralHernia, Umbilical

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Maaike Vierstraete

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maaike Vierstraete, MD

CONTACT

003292467400maaikevierstraete@icloud.com

Filip Muysoms, MD

CONTACT

003282467400filip.muysoms@azmmsj.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One single group of 20 patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor Department General Surgery

Study Record Dates

First Submitted

September 25, 2022

First Posted

October 12, 2022

Study Start

February 1, 2023

Primary Completion

December 31, 2023

Study Completion

April 1, 2025

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

BE(1)