An interventional study of Hernia repair in Ventral Hernia, Umbilical Hernia and Ventral Incisional Hernia, sponsored by Algemeen Ziekenhuis Maria Middelares. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Treatment
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®).
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's planned enrollment of 20 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
Compared within Hernia, Umbilical, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Ventral. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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
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)
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
Operation duration
Recording of the operation duration needed for robot-assisted ventral TAPP procedure
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
Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome
Time frame: 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).
Time frame: Preoperatively, 30 days, 13 months
Started Feb 2023 (actual). Primary completion is estimated for Dec 2023, 10 months after the start.
Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Algemeen Ziekenhuis Maria Middelares