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NCT Number: NCT05216276

Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Robotic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clarunis AG

Basel, Basel-Landschaft, 4002, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEP

Procedure

Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair

rTAPP

Procedure

robotic transabdominal preperitoneal (TAPP) inguinal hernia repair

Primary outcomes

  1. Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10)

    Time frame: 24 hours

    Pain at coughing 24 hours after surgery measured on a numeric rating scale (NRS 0-10) while coughing

Secondary outcomes

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

    Time frame: 2 hours

    NRS 2 hours post surgery

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

    Time frame: 7 days

    NRS 7 days post surgery

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

    Time frame: 30 days

    NRS 30 days post surgery

  4. EQ-5D-5L (European Quality of Life - 5 Dimension - 5 Level) questionnaire

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During surgery

  8. Name and Dosage of pain medication intraoperativ

    Time frame: During surgery

    Amount of intraoperative pain medication

  9. Procedure time

    Time frame: During surgery

    Procedure time

  10. Time in the OR block

    Time frame: During surgery

    Time in the OR block

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

    Time frame: 24 hours

    For day surgery hours in outpatient clinic until discharge

  12. Time measured in days patients are hospitalized after surgery

    Time frame: 7 days

    For hospitalized patients postoperative stay in days

  13. Pain medication postoperative

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

    Recurrence rate 6 and 12 months postoperative

  16. SF-12 (Short Form)

    Time frame: 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)

    Time frame: 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

    Time frame: 1 day

    Ergonomics for the surgeon measured by NASA TLX

  19. Costs per patients

    Time frame: 30 days

    Costs for surgery per patient according to the accounting department

  20. Sick leave

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Clarunis - Universitäres Bauchzentrum Basel
  • St. Claraspital AG

Registry information

Official study title

Robotic Versus Conventional Minimal-invasive Inguinal Hernia Repair - a Prospective, Randomized and Blinded Clinical Trial

Acronym: ROGER-RCT

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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