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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05216276
Other study ID # 2021-01655
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 ยง 404.1567 Physical exertion requirement 1 day
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