An observational study in Hernia, Umbilical, sponsored by Filip Muysoms. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by Filip Muysoms · Observational
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic assisted surgery for the treatment of incisional hernia's of 40 patients treated in Maria Middelares in laparoscopic rTARUP technique.
Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients with an umbilical hernia larger than 2 cm in Maria Middelares, Ghent.
As previously described in a chapter in a surgical guide and in a review article on the surgical fixation technique for laparoscopic umbilical hernia repair, the used technique has been proven feasible end safe.
Robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the applicability of this technology within the field of general surgery.
For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the US have experiences in structured treatment programs.
From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery, including the laparoscopic TARUP umbilical hernia repair.
Main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. However, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery.
The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of umbilical hernias by 40 patients in Maria Middelares hospital.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 45 is below the median of 118 across 25 observational studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical 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 eligible patients who are scheduled for laparoscopic repair of an umbillical hernia. A total of 40 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.
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.
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.
obot-assisted rTARUP technique
duration of operation
Recording of the operation time needed for robot-assisted TARUP umbilical hernia repair
Time frame: from the start of the operation until the end of the operation, approximately 4 hours
intra-operative complications
Intra-operative complications registered until 4 weeks after the hernia repair
Time frame: until 4 weeks post-operative
post-operative complications
Post-operative complications detected until 1 year after hernia repair by clinical follow up.
Time frame: until 1 year post-operative
Questionnaire about the Quality of Life
Quality of Life measured with the EuraHS QoL score preoperative and until 1 year after hernia repair by clinical follow up.
Time frame: until 1 year post-operative
Plan to share: No
The record gives a start of Sep 2016, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Filip Muysoms