ROGER-RCT: Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: TEP Patient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair. |
Procedure: TEP
Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair
|
Experimental: rTAPP Patient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair. |
Procedure: rTAPP
robotic transabdominal preperitoneal (TAPP) inguinal hernia repair
|
Outcome Measures
Primary Outcome Measures
- Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10) [24 hours]
Pain at coughing 24 hours after surgery measured on a numeric rating scale (NRS 0-10) while coughing
Secondary Outcome Measures
- Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10) [2 hours]
NRS 2 hours post surgery
- Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10) [7 days]
NRS 7 days post surgery
- Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10) [30 days]
NRS 30 days post surgery
- EQ-5D-5L (European Quality of Life - 5 Dimension - 5 Level) questionnaire [24hours, 7 and 30 days, 6 and 12 months]
EQ-5D-5L 24hours, 7 and 30 days, 6 and 12 months; minimum score = 5, max = 25, lower is better
- SF-6D (Short Form - Dimension) questionnaire [24hours, 7 and 30 days, 6 and 12 months]
SF-6D 24hours, 7 and 30 days, 6 and 12 months; minimum score = 0.0, max = 1.0, higher is better
- ICECAP-O (ICEpop CAPability measure for Older people) questionnaire [24hours, 7 and 30 days, 6 and 12 months]
ICECAP-O 24hours, 7 and 30 days, 6 and 12 months; minimum score = 5, max = 20, higher is better
- Intraoperative complications [During surgery]
- Name and Dosage of pain medication intraoperativ [During surgery]
Amount of intraoperative pain medication
- Procedure time [During surgery]
Procedure time
- Time in the OR block [During surgery]
Time in the OR block
- Time measured in hours patients are in the outpatient clinic until discharge [24 hours]
For day surgery hours in outpatient clinic until discharge
- Time measured in days patients are hospitalized after surgery [7 days]
For hospitalized patients postoperative stay in days
- Pain medication postoperative [12 months]
Prescribed and actually taken pain medication postoperative 24 hours, 7 days and 30 days, 6 and 12 months after surgery
- Postoperative morbidity [30 days]
Postoperative morbidity classified according to the Dindo-Clavien classification and scored according to the Comprehensive complication index (CCI) up to 30 days after surgery
- Recurrence rate [12 months]
Recurrence rate 6 and 12 months postoperative
- SF-12 (Short Form) [12 months]
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.
- Carolinas Comfort Scale (CCS) [12 months]
Carolinas Comfort Scale (CCS) 30 days, 6 months, and 12 months postoperative; minimum score = 8, max = 48, higher is better
- Ergonomics for the surgeon [1 day]
Ergonomics for the surgeon measured by NASA TLX
- Costs per patients [30 days]
Costs for surgery per patient according to the accounting department
- Sick leave [12 months]
ays until resumption of work or days until resumption of activities of daily life, and estimated sick leave by patient
- Costs for sick leave [12 months]
Costs for sick leave (days multiplied by average daily costs of sick leave in Switzerland according to the Swiss National Accident Insurance Fund (SUVA))
- Type of labor including the relative activity level [1 day]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients older than 18 years of age and able to understand and give their informed consent for the study.
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Primary unilateral or bilateral hernia
Exclusion Criteria:
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Recurrent hernia
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with previous open abdominal surgery at or below the umbilicus
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need of an open inguinal hernia repair (patient's preference, unable to undergo general anesthesia, unable to tolerate pneumoperitoneum)
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liver disease defined by the presence of ascites
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end-stage renal disease requiring dialysis
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unable to give informed consent
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need of an emergency surgery
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pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clarunis AG | Basel | BL | Switzerland | 4002 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
- Clarunis - Universitäres Bauchzentrum Basel
- St. Claraspital AG
Investigators
- Principal Investigator: Fiorenzo V Angehrn, Dr. med., Clarunis AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-01655