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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
Clarunis AG
Basel, Basel-Landschaft, Switzerland
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
Time frame: 24 hours
Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10)
NRS 2 hours post surgery
Time frame: 2 hours
Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10)
NRS 7 days post surgery
Time frame: 7 days
Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10)
NRS 30 days post surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24hours, 7 and 30 days, 6 and 12 months
Intraoperative complications
Time frame: During surgery
Name and Dosage of pain medication intraoperativ
Amount of intraoperative pain medication
Time frame: During surgery
Procedure time
Procedure time
Time frame: During surgery
Time in the OR block
Time in the OR block
Time frame: During surgery
Time measured in hours patients are in the outpatient clinic until discharge
For day surgery hours in outpatient clinic until discharge
Time frame: 24 hours
Time measured in days patients are hospitalized after surgery
For hospitalized patients postoperative stay in days
Time frame: 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
Time frame: 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
Time frame: 30 days
Recurrence rate
Recurrence rate 6 and 12 months postoperative
Time frame: 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.
Time frame: 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
Time frame: 12 months
Ergonomics for the surgeon
Ergonomics for the surgeon measured by NASA TLX
Time frame: 1 day
Costs per patients
Costs for surgery per patient according to the accounting department
Time frame: 30 days
Sick leave
ays until resumption of work or days until resumption of activities of daily life, and estimated sick leave by patient
Time frame: 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))
Time frame: 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
Time frame: 1 day
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