An observational study in Hernia, Incisional, sponsored by Filip Muysoms. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Filip Muysoms · Observational
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.
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.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's enrollment of 20 is below the median of 150 across 75 observational studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Filip Muysoms is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients scheduled for robot assisted laparoscopic retromuscular repair (rTARUP =robotic Trans Abdominal Retromuscular Umbilical Prosthesis) of a midline ventral hernia will be invited to take part in the study. Both primary ventral and incisional midline hernias will be included (EHS classification M1-M5).
A total of 20 patients will be enrolled in this observational study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
robot-assisted rTARUP technique
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)
Time frame: 1 month and 13 month post-operatively
Change in mesh surface between implantation surface size
Change in mesh surface between implantation surface size, surface at 1m and at 13m
Time frame: 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
Time frame: 1 month and 13 month post-operatively
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
Time frame: 1 month and 13 month post-operatively
Operation duration
recording of the operation duration needed for robo-assisted TARUP
Time frame: once during operation
Intra-operative complications
Intra-operative complications registered until 4 weeks after the hernia repair
Time frame: until 4 weeks post-operative
Early post-operative complications
Early post-operative complications detected until 30 days after hernia repair
Time frame: until 30 days post-operative
Late complications
Late complications (after 30 days)
Time frame: after 30 days post-operative
Quality of Life questionnaire
A questionnaire will be used to measured life quality of the participants preoperatively and at 1m and 13m postoperatively
Time frame: preoperative and 1 month and 13 month post-operatively
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Jun 2021, 44 months.
Of 24 observational studies under Incisional Hernia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 61. This study's 44 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Filip Muysoms