MRI Imaging of Ipsilateral Retromuscular Access

Hernia, Incisional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03380312
• Other study ID #: IRMA
• Status: Active, not recruiting
• Start date: September 26, 2017
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months.

Description:

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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months. Possibly the ipsilateral retromuscular access could induce some atrophy of the rectus muscles.

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. Dr.Muysoms will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers and Dr. Heindryckx 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.

The investigators want to show that with this type of mesh it is possible to visualize the mesh after retromusculare placement in vivo 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: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 20 patients selected and operated by PI.

Exclusion Criteria:

• <18 years

• Emergency surgery (incarcerated hernia)

• Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)

• Lateral hernias

• 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, Incisional
• Incisional Hernia

Intervention

Procedure:
• rTARUP technique
robot-assisted rTARUP technique

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Filip Muysoms

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the 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	Volume of the rectus muscle at the level of the umbilicus	Volume of the rectus muscle at the level of the umbilicus on both sides at 1m and at 13m	1 month and 13 month post-operatively
Secondary	Operation duration	recording of the operation duration needed for robo-assisted TARUP	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	A questionnaire will be used to measured life quality of the participants preoperatively and at 1m and 13m postoperatively	preoperative and 1 month and 13 month post-operatively