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

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).

Study Overview

• Status: Recruiting
• Conditions: Hernia, Inguinal; Robotic Surgical Procedures
• Intervention / Treatment: Procedure: TEP; Procedure: rTAPP

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiorenzo V Angehrn, Dr. med.; Phone Number: +41 61 777 73 17; Email: fiorenzo.angehrn@clarunis.ch
• Study Contact Backup: Name: Daniel C Steinemann, PD Dr. med.; Phone Number: +41 61 777 75 27; Email: daniel.steinemann@clarunis.ch

Study Locations

• Switzerland
  • BL
    • Basel, BL, Switzerland, 4002
      • Recruiting
      • Clarunis AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TEP; Patient with uni- or bilateral inguinal hernia receiving a laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair.	Procedure: TEP; Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair
Experimental: rTAPP; Patient with uni- or bilateral inguinal hernia receiving a robotic transabdominal preperitoneal (TAPP) inguinal hernia repair.	Procedure: rTAPP; robotic transabdominal preperitoneal (TAPP) inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10)	NRS 2 hours post surgery	2 hours
Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10)	NRS 7 days post surgery	7 days
Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10)	NRS 30 days post surgery	30 days
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	24hours, 7 and 30 days, 6 and 12 months
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	24hours, 7 and 30 days, 6 and 12 months
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	24hours, 7 and 30 days, 6 and 12 months
Intraoperative complications		During surgery
Name and Dosage of pain medication intraoperativ	Amount of intraoperative pain medication	During surgery
Procedure time	Procedure time	During surgery
Time in the OR block	Time in the OR block	During surgery
Time measured in hours patients are in the outpatient clinic until discharge	For day surgery hours in outpatient clinic until discharge	24 hours
Time measured in days patients are hospitalized after surgery	For hospitalized patients postoperative stay in days	7 days
Pain medication postoperative	Prescribed and actually taken pain medication postoperative 24 hours, 7 days and 30 days, 6 and 12 months after surgery	12 months
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	30 days
Recurrence rate	Recurrence rate 6 and 12 months postoperative	12 months
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.	12 months
Carolinas Comfort Scale (CCS)	Carolinas Comfort Scale (CCS) 30 days, 6 months, and 12 months postoperative; minimum score = 8, max = 48, higher is better	12 months
Ergonomics for the surgeon	Ergonomics for the surgeon measured by NASA TLX	1 day
Costs per patients	Costs for surgery per patient according to the accounting department	30 days
Sick leave	ays until resumption of work or days until resumption of activities of daily life, and estimated sick leave by patient	12 months
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))	12 months
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	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: St. Claraspital AG; Clarunis - Universitäres Bauchzentrum Basel
• Investigators: Principal Investigator: Fiorenzo V Angehrn, Dr. med., Clarunis AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 2021-01655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No