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Hernia, InguinalROGER-RCTNCT05216276

Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

A study testing TEP and rTAPP in people with Hernia, Inguinal and Robotic Surgical Procedures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia, Inguinal, Robotic Surgical Procedures
What is being tested?
TEP and rTAPP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteSwitzerland
Study dates
17 Jan 2022to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years of age and able to understand and give their informed consent for the study.
  • Primary unilateral or bilateral hernia

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Clarunis AG

    Basel, Basel-Landschaft, 4002

Other trials in Switzerland

About this study

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

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).

Being tested
TEP, rTAPP
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEPProcedure or surgery

    Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair

  • rTAPPProcedure or surgery

    robotic transabdominal preperitoneal (TAPP) inguinal hernia repair

Study groups in NCT05216276
Study groupRoleWhat they receive
TEPActive comparatorPatient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair.
Receives: Procedure: TEP
rTAPPExperimentalPatient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair.
Receives: Procedure: rTAPP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 hours

Secondary outcomes (22)

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

    NRS 2 hours post surgery

    Measured: 2 hours

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

    NRS 7 days post surgery

    Measured: 7 days

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

    NRS 30 days post surgery

    Measured: 30 days

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

    EQ-5D-5L 24hours, 7 and 30 days, 6 and 12 months; minimum score = 5, max = 25, lower is better

    Measured: 24hours, 7 and 30 days, 6 and 12 months

  5. SF-6D (Short Form - Dimension) questionnaire

    SF-6D 24hours, 7 and 30 days, 6 and 12 months; minimum score = 0.0, max = 1.0, higher is better

    Measured: 24hours, 7 and 30 days, 6 and 12 months

  6. ICECAP-O (ICEpop CAPability measure for Older people) questionnaire

    ICECAP-O 24hours, 7 and 30 days, 6 and 12 months; minimum score = 5, max = 20, higher is better

    Measured: 24hours, 7 and 30 days, 6 and 12 months

  7. Intraoperative complications

    Measured: During surgery

  8. Name and Dosage of pain medication intraoperativ

    Amount of intraoperative pain medication

    Measured: During surgery

  9. Procedure time

    Procedure time

    Measured: During surgery

  10. Time in the OR block

    Time in the OR block

    Measured: During surgery

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

    For day surgery hours in outpatient clinic until discharge

    Measured: 24 hours

  12. Time measured in days patients are hospitalized after surgery

    For hospitalized patients postoperative stay in days

    Measured: 7 days

  13. Pain medication postoperative

    Prescribed and actually taken pain medication postoperative 24 hours, 7 days and 30 days, 6 and 12 months after surgery

    Measured: 12 months

  14. Postoperative morbidity

    Postoperative morbidity classified according to the Dindo-Clavien classification and scored according to the Comprehensive complication index (CCI) up to 30 days after surgery

    Measured: 30 days

  15. Recurrence rate

    Recurrence rate 6 and 12 months postoperative

    Measured: 12 months

  16. SF-12 (Short Form)

    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.

    Measured: 12 months

  17. Carolinas Comfort Scale (CCS)

    Carolinas Comfort Scale (CCS) 30 days, 6 months, and 12 months postoperative; minimum score = 8, max = 48, higher is better

    Measured: 12 months

  18. Ergonomics for the surgeon

    Ergonomics for the surgeon measured by NASA TLX

    Measured: 1 day

  19. Costs per patients

    Costs for surgery per patient according to the accounting department

    Measured: 30 days

  20. Sick leave

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

    Measured: 12 months

  21. Costs for sick leave

    Costs for sick leave (days multiplied by average daily costs of sick leave in Switzerland according to the Swiss National Accident Insurance Fund (SUVA))

    Measured: 12 months

  22. Type of labor including the relative activity level

    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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start17 Jan 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216276
Sponsor's protocol ID
2021-01655
Acronym
ROGER-RCT
Status last verified
Jan 2025
First submitted
30 Dec 2021
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Angehrn FV, Susstrunk J, Schneider R, Baltzer K, Muller BP, Baur J, Steinemann DC. Robotic versus laparoscopic minimally invasive inguinal hernia repair: randomized clinical trial (the ROGER trial). Br J Surg. 2025 Dec 24;113(1):znaf283. doi: 10.1093/bjs/znaf283.

    PubMed 41511872

  • 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.

    PubMed 35794884

Questions about this trial

What is this clinical trial studying?

A study testing TEP and rTAPP in people with Hernia, Inguinal and Robotic Surgical Procedures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05216276, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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