Robotic Utility for Surgical Treatment of Umbilical Hernias

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Observational Cohort Study of Robot-assisted Laparoscopic Hernia Umbilical Hernia Repair (rTARUP)

Conditions
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Hernia, Umbilical

Intervention / Treatment
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* Procedure: rTARUP technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 patients selected and operated by the PI. Exclusion Criteria: patients under the age of 18 pregnancy no Informed Consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: rTARUP technique|obot-assisted rTARUP technique|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of operation | Recording of the operation time needed for robot-assisted TARUP umbilical hernia repair | from the start of the operation until the end of the operation, approximately 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative complications | Intra-operative complications registered until 4 weeks after the hernia repair | until 4 weeks post-operative | 
| post-operative complications | Post-operative complications detected until 1 year after hernia repair by clinical follow up. | 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. | until 1 year post-operative |