Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

Last updated: January 27, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hernia

Treatment

TEP

rTAPP

Clinical Study ID

NCT05216276
2021-01655
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients older than 18 years of age and able to understand and give their informedconsent for the study.

  • Primary unilateral or bilateral hernia

Exclusion

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 undergogeneral 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

Study Design

Total Participants: 182
Treatment Group(s): 2
Primary Treatment: TEP
Phase:
Study Start date:
January 17, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Clarunis AG

    Basel, BL 4002
    Switzerland

    Site Not Available

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