Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

Study Overview
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Brief Summary
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Minimal invasive techniques have become a well established approach for inguinal hernia repair over the last decade in developed countries. Different techniques such as total extraperitoneal endoscopic hernioplasty (TEP) and transabdominal preperitoneal hernia repair (TAPP) have been described. These studies show comparable results in short and long term outcome. Robotic inguinal hernia surgery enables an even more precise dissection within the preperitoneal layer thus preserving the nerves of the lateral abdominal wall. This may translate into a reduced level of acute and chronic postoperative pain as previously reported by retrospective case series. The role of robotic surgery for inguinal hernia repair in regard of postoperative pain and recovery has not been investigated in randomized and blinded clinical studies yet. With this randomized and blinded trial the investigators compare robotic TAPP (rTAPP) to conventional TEP with a decreased pain level shortly after surgery as primary outcome (numeric rating scale - NRS). A reduced postoperative NRS for pain may translate into faster recovery and less chronic pain, secondary endpoints include comparison of pain in a longer course (short-form inguinal pain questionnaire (sf-IPQ)), quality of life / health status (Baseline Short Form-12 (SF-12), Carolinas Comfort Scale (CCS)), complications (Comprehensive Complication Index - CCI), rate of recurrence, , economic impact in terms of costs of surgery per patient, for the institution, the sick leave and the cost-effectiveness of health intervention (SF-6D, EQ-5D, ICECAP-O). Also included are ergonomics for the surgeon (NASA TLX).

Official Title
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Robotic Versus Conventional Minimal-invasive Inguinal Hernia Repair - a Prospective, Randomized and Blinded Clinical Trial

Conditions
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Hernia, Inguinal, Robotic Surgical Procedures

Intervention / Treatment
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* Procedure: TEP
* Procedure: rTAPP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years of age and able to understand and give their informed consent for the study. Primary unilateral or bilateral hernia Exclusion Criteria: Recurrent hernia with previous open abdominal surgery at or below the umbilicus need of an open inguinal hernia repair (patient's preference, unable to undergo general anesthesia, unable to tolerate pneumoperitoneum) liver disease defined by the presence of ascites end-stage renal disease requiring dialysis unable to give informed consent need of an emergency surgery pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with indication for inguinal hernia repair are randomized to get a robotic TAPP (rTAPP) or a conventional TEP. Results will be compared primarily pain after 24h hours.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEP<br>Patient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair. | Procedure: TEP<br>* Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair<br>|
| Experimental: rTAPP<br>Patient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair. | Procedure: rTAPP<br>* robotic transabdominal preperitoneal (TAPP) inguinal hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10) | Pain at coughing 24 hours after surgery measured on a numeric rating scale (NRS 0-10) while coughing | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10) | NRS 2 hours post surgery | 2 hours | 
| Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10) | NRS 7 days post surgery | 7 days | 
| Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10) | NRS 30 days post surgery | 30 days | 
| EQ-5D-5L (European Quality of Life - 5 Dimension - 5 Level) questionnaire | EQ-5D-5L 24hours, 7 and 30 days, 6 and 12 months; minimum score = 5, max = 25, lower is better | 24hours, 7 and 30 days, 6 and 12 months | 
| SF-6D (Short Form - Dimension) questionnaire | SF-6D 24hours, 7 and 30 days, 6 and 12 months; minimum score = 0.0, max = 1.0, higher is better | 24hours, 7 and 30 days, 6 and 12 months | 
| ICECAP-O (ICEpop CAPability measure for Older people) questionnaire | ICECAP-O 24hours, 7 and 30 days, 6 and 12 months; minimum score = 5, max = 20, higher is better | 24hours, 7 and 30 days, 6 and 12 months | 
| Intraoperative complications |  | During surgery | 
| Name and Dosage of pain medication intraoperativ | Amount of intraoperative pain medication | During surgery | 
| Procedure time | Procedure time | During surgery | 
| Time in the OR block | Time in the OR block | During surgery | 
| Time measured in hours patients are in the outpatient clinic until discharge | For day surgery hours in outpatient clinic until discharge | 24 hours | 
| Time measured in days patients are hospitalized after surgery | For hospitalized patients postoperative stay in days | 7 days | 
| Pain medication postoperative | Prescribed and actually taken pain medication postoperative 24 hours, 7 days and 30 days, 6 and 12 months after surgery | 12 months | 
| Postoperative morbidity | Postoperative morbidity classified according to the Dindo-Clavien classification and scored according to the Comprehensive complication index (CCI) up to 30 days after surgery | 30 days | 
| Recurrence rate | Recurrence rate 6 and 12 months postoperative | 12 months | 
| SF-12 (Short Form) | SF-12 30 days, 6 months, and 12 months postoperative; The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | 12 months | 
| Carolinas Comfort Scale (CCS) | Carolinas Comfort Scale (CCS) 30 days, 6 months, and 12 months postoperative; minimum score = 8, max = 48, higher is better | 12 months | 
| Ergonomics for the surgeon | Ergonomics for the surgeon measured by NASA TLX | 1 day | 
| Costs per patients | Costs for surgery per patient according to the accounting department | 30 days | 
| Sick leave | ays until resumption of work or days until resumption of activities of daily life, and estimated sick leave by patient | 12 months | 
| Costs for sick leave | Costs for sick leave (days multiplied by average daily costs of sick leave in Switzerland according to the Swiss National Accident Insurance Fund (SUVA)) | 12 months | 
| Type of labor including the relative activity level | Type of labor including the relative activity level (sedentary work, light work, medium work, heavy work, very heavy work, retired/unemployed) according to US Code of Federal Regulations § 404.1567 Physical exertion requirement | 1 day |