Hernia, Inguinal, Robotic Surgical Procedures
Conditions
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).
Interventions
PROCEDURETEP
Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair
PROCEDURErTAPP
robotic transabdominal preperitoneal (TAPP) inguinal hernia repair
Sponsors
Clarunis - Universitäres Bauchzentrum Basel
St. Claraspital AG
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
patient and assessor blinded study
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10) | 2 hours | NRS 2 hours post 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 |
| 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 |
| Time measured in days patients are hospitalized after surgery | 7 days | For hospitalized patients postoperative stay in days |
Countries
Switzerland
Outcome results
None listed