Clinical trial NCT05216276: Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair
Official title: Robotic Versus Conventional Minimal-invasive Inguinal Hernia Repair - a Prospective, Randomized and Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hernia, Inguinal
Robotic Surgical Procedures
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clarunis - Universitäres Bauchzentrum Basel
name: St. Claraspital AG
First posted: 2022-01-31
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10)
timeFrame: 24 hours
Secondary outcomes:
measure: Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10)
timeFrame: 2 hours
measure: Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10)
timeFrame: 7 days
measure: Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10)
timeFrame: 30 days
measure: EQ-5D-5L (European Quality of Life - 5 Dimension - 5 Level) questionnaire
timeFrame: 24hours, 7 and 30 days, 6 and 12 months
measure: SF-6D (Short Form - Dimension) questionnaire
timeFrame: 24hours, 7 and 30 days, 6 and 12 months
measure: ICECAP-O (ICEpop CAPability measure for Older people) questionnaire
timeFrame: 24hours, 7 and 30 days, 6 and 12 months
measure: Intraoperative complications
timeFrame: During surgery
measure: Name and Dosage of pain medication intraoperativ
timeFrame: During surgery
measure: Procedure time
timeFrame: During surgery
measure: Time in the OR block
timeFrame: During surgery
measure: Time measured in hours patients are in the outpatient clinic until discharge
timeFrame: 24 hours
measure: Time measured in days patients are hospitalized after surgery
timeFrame: 7 days
measure: Pain medication postoperative
timeFrame: 12 months
measure: Postoperative morbidity
timeFrame: 30 days
measure: Recurrence rate
timeFrame: 12 months
measure: SF-12 (Short Form)
timeFrame: 12 months
measure: Carolinas Comfort Scale (CCS)
timeFrame: 12 months
measure: Ergonomics for the surgeon
timeFrame: 1 day
measure: Costs per patients
timeFrame: 30 days
measure: Sick leave
timeFrame: 12 months
measure: Costs for sick leave
timeFrame: 12 months
measure: Type of labor including the relative activity level
timeFrame: 1 day
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clarunis AG
state: BL
Study officials:
affiliation: Clarunis AG
name: Fiorenzo V Angehrn, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.