Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair
- Conditions
- Robotic Surgical ProceduresHernia, Inguinal
- Interventions
- Procedure: TEPProcedure: rTAPP
- Registration Number
- NCT05216276
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 182
- Patients older than 18 years of age and able to understand and give their informed consent for the study.
- Primary unilateral or bilateral hernia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEP TEP Patient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair. rTAPP rTAPP Patient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Procedure time During surgery Procedure time
Costs per patients 30 days Costs for surgery per patient according to the accounting department
Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10) 30 days NRS 30 days post surgery
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
Time in the OR block During surgery Time in the OR block
Time measured in days patients are hospitalized after surgery 7 days For hospitalized patients postoperative stay in days
Ergonomics for the surgeon 1 day Ergonomics for the surgeon measured by NASA TLX
Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10) 7 days NRS 7 days post surgery
Intraoperative complications During surgery 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
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
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
Name and Dosage of pain medication intraoperativ During surgery Amount of intraoperative pain medication
Time measured in hours patients are in the outpatient clinic until discharge 24 hours For day surgery hours in outpatient clinic until discharge
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
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))
Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10) 2 hours NRS 2 hours post 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
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
Trial Locations
- Locations (1)
Clarunis AG
🇨🇭Basel, BL, Switzerland