Robotic Utility for Surgical Treatment of Groin 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 inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.

Detailed Description
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Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects. 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 TAPP inguinal 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 inguinal hernias by 50 patients in Maria Middelares hospital.

Official Title
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Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: rTAPP technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 patients selected and operated by the PI. Exclusion Criteria: patients under the age of 18 pregnancy BMI > 35 recurrent groin hernia 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: rTAPP technique|robot-assisted rTAPP technique|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the operation | Recording of the operation time needed for robot-assisted TAPP groin hernia repair | from the start of the operation until the end of the operation, approximately 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative complications | Intra-operative complications registered until 4 weeks post-operative | until 4 weeks post-operative | 
| post-operative complications | Post-operative complications detected until 4 weeks after hernia repair by clinical follow up. | until 4 weeks post-operative | 
| Quality of Life | Quality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up. | until 4 weeks post-operative |