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

Hernia, Inguinal Clinical Trial

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

Clinical 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. 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05216276
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact Fiorenzo V Angehrn, Dr. med.
Phone +41 61 777 73 17
Email fiorenzo.angehrn@clarunis.ch
Status Recruiting
Phase N/A
Start date January 17, 2022
Completion date December 31, 2023
View Details
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