- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975414
Robotic Utility for Surgical Treatment of Umbilical Hernias (Robust_2)
Prospective Observational Cohort Study of Robot-assisted Laparoscopic Hernia Umbilical Hernia Repair (rTARUP)
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- AZ Maria Middelares
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 40 patients selected and operated by the PI.
Exclusion Criteria:
- patients under the age of 18
- pregnancy
- no Informed Consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of operation
Time Frame: from the start of the operation until the end of the operation, approximately 4 hours
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Recording of the operation time needed for robot-assisted TARUP umbilical hernia repair
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from the start of the operation until the end of the operation, approximately 4 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intra-operative complications
Time Frame: until 4 weeks post-operative
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Intra-operative complications registered until 4 weeks after the hernia repair
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until 4 weeks post-operative
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post-operative complications
Time Frame: until 1 year post-operative
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Post-operative complications detected until 1 year after hernia repair by clinical follow up.
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until 1 year post-operative
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Questionnaire about the Quality of Life
Time Frame: until 1 year post-operative
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Quality of Life measured with the EuraHS QoL score preoperative and until 1 year after hernia repair by clinical follow up.
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until 1 year post-operative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Filip Muysoms, MD, PhD, Maria Middelares Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Robust_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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