Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

— ROGER-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216276
• Other study ID #: 2021-01655
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Fiorenzo V Angehrn, Dr. med.
• Phone: +41 61 777 73 17
• Email: fiorenzo.angehrn[@]clarunis.ch
• Is FDA regulated: No
• Study type: Interventional

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Robotic Surgical Procedures

Intervention

Procedure:
• TEP
Laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair
• rTAPP
robotic transabdominal preperitoneal (TAPP) inguinal hernia repair

Locations

Country	Name	City	State
Switzerland	Clarunis AG	Basel	BL

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clarunis - Universitäres Bauchzentrum Basel, St. Claraspital AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10)	NRS 2 hours post surgery	2 hours
Secondary	Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10)	NRS 7 days post surgery	7 days
Secondary	Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10)	NRS 30 days post surgery	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Intraoperative complications		During surgery
Secondary	Name and Dosage of pain medication intraoperativ	Amount of intraoperative pain medication	During surgery
Secondary	Procedure time	Procedure time	During surgery
Secondary	Time in the OR block	Time in the OR block	During surgery
Secondary	Time measured in hours patients are in the outpatient clinic until discharge	For day surgery hours in outpatient clinic until discharge	24 hours
Secondary	Time measured in days patients are hospitalized after surgery	For hospitalized patients postoperative stay in days	7 days
Secondary	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
Secondary	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
Secondary	Recurrence rate	Recurrence rate 6 and 12 months postoperative	12 months
Secondary	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
Secondary	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
Secondary	Ergonomics for the surgeon	Ergonomics for the surgeon measured by NASA TLX	1 day
Secondary	Costs per patients	Costs for surgery per patient according to the accounting department	30 days
Secondary	Sick leave	ays until resumption of work or days until resumption of activities of daily life, and estimated sick leave by patient	12 months
Secondary	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
Secondary	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