ROGER-RCT: Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05216276
Collaborator
Clarunis - Universitäres Bauchzentrum Basel (Other), St. Claraspital AG (Other)
182
1
2
23.4
7.8

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
  • Procedure: TEP
  • Procedure: rTAPP
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
patient and assessor blinded study
Primary Purpose:
Treatment
Official Title:
Robotic Versus Conventional Minimal-invasive Inguinal Hernia Repair - a Prospective, Randomized and Blinded Clinical Trial
Actual Study Start Date :
Jan 17, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  1. Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10) [2 hours]

    NRS 2 hours post surgery

  2. Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10) [7 days]

    NRS 7 days post surgery

  3. Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10) [30 days]

    NRS 30 days post surgery

  4. 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

  5. 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

  6. 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

  7. Intraoperative complications [During surgery]

  8. Name and Dosage of pain medication intraoperativ [During surgery]

    Amount of intraoperative pain medication

  9. Procedure time [During surgery]

    Procedure time

  10. Time in the OR block [During surgery]

    Time in the OR block

  11. Time measured in hours patients are in the outpatient clinic until discharge [24 hours]

    For day surgery hours in outpatient clinic until discharge

  12. Time measured in days patients are hospitalized after surgery [7 days]

    For hospitalized patients postoperative stay in days

  13. 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

  14. 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

  15. Recurrence rate [12 months]

    Recurrence rate 6 and 12 months postoperative

  16. 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.

  17. 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

  18. Ergonomics for the surgeon [1 day]

    Ergonomics for the surgeon measured by NASA TLX

  19. Costs per patients [30 days]

    Costs for surgery per patient according to the accounting department

  20. Sick leave [12 months]

    ays until resumption of work or days until resumption of activities of daily life, and estimated sick leave by patient

  21. 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))

  22. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05216276
Other Study ID Numbers:
  • 2021-01655
First Posted:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022