Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

NCT05216276 | Active Not Recruiting DMC

• 1 other identifier: 2021-01655
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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).

Conditions

Hernia, Inguinal; Robotic Surgical Procedures

Outcome Measures

Primary Outcomes (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

  24 hours

Secondary Outcomes (22)

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

  2 hours

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

  7 days

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

  30 days

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

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

• SF-6D (Short Form - Dimension) questionnaire

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

Study Arms (2)

TEP

ACTIVE COMPARATOR

Patient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair.

Procedure: TEP

rTAPP

EXPERIMENTAL

Patient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair.

Procedure: rTAPP

Interventions

TEP PROCEDURE

Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair

TEP

rTAPP PROCEDURE

robotic transabdominal preperitoneal (TAPP) inguinal hernia repair

rTAPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clarunis - Universitäres Bauchzentrum Basel: collaborator
• St. Claraspital AG: collaborator

Study Sites (1)

Clarunis AG

Basel, Basel-Landschaft, 4002, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 41511872 DERIVED

• 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.

  PMID: 35794884 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiorenzo V Angehrn, Dr. med.

  Clarunis AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patient and assessor blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 31, 2022
• Study Start: January 17, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)