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| Name | Class |
|---|---|
| Clarunis - Universitรคres Bauchzentrum Basel | OTHER |
| St. Claraspital AG | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEP | Active Comparator | Patient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair. |
|
| rTAPP | Experimental | Patient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEP | Procedure | Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fiorenzo V Angehrn, Dr. med. | Clarunis AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clarunis AG | Basel | Basel-Landschaft | 4002 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41511872 | Derived | Angehrn FV, Susstrunk J, Schneider R, Baltzer K, Muller BP, Baur J, Steinemann DC. Robotic versus laparoscopic minimally invasive inguinal hernia repair: randomized clinical trial (the ROGER trial). Br J Surg. 2025 Dec 24;113(1):znaf283. doi: 10.1093/bjs/znaf283. | |
| 35794884 | Derived | Angehrn FV, Neuschutz KJ, Baur J, Schneider R, Wilhelm A, Stoll L, Susstrunk J, von Flue M, Bolli M, Steinemann DC. Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial. Int J Surg Protoc. 2022 Jun 6;26(1):27-34. doi: 10.29337/ijsp.175. eCollection 2022. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C072829 | tetraethylpyrazine |
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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.
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patient and assessor blinded study
| rTAPP |
| Procedure |
robotic transabdominal preperitoneal (TAPP) inguinal hernia repair |
|
| 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 ยง 404.1567 Physical exertion requirement | 1 day |