Robotic Assisted Inguinal Hernia Repair
Conditions
Keywords
Versius, Robotic surgery, Inguinal hernia
Brief summary
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
Interventions
DEVICEVersius Surgical System
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures.
Sponsors
Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
CMR Surgical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery. 2. Patients providing written informed consent to participate in the study.
Exclusion criteria
1. Patient unwilling to provide informed consent. 2. Medical contraindication for general anaesthesia or minimally invasive procedure. 3. Patient participation in an interventional clinical study that could impact primary outcomes results. 4. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above. 5. Patients undergoing a concomitant surgical procedure. 6. Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg/m2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | Up to completion of surgery | Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery |
| Serious Adverse Event rate | Up to 30 days post procedure | Rate of total procedure related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative adverse events | Up to completion of surgery | Adverse events that occur during surgery |
| Blood transfusion | Up to completion of surgery | Need for blood transfusion during surgery as well as amount transfused |
| Device deficiencies | Up to completion of surgery | Any device deficiencies of Versius during surgery |
| Reoperation within 24 hours | 24 hours post-surgery | Need for reoperation after initial surgery |
| Operative time | Up to completion of surgery | Surgical time from skin incision to skin closure |
| Adverse events | Up to 30 days post-surgery | Rate of adverse events |
| Readmission | Up to 30 days post-surgery | Hospital readmission after post-surgical discharge |
| Reoperation within 30 days | Up to 30 days post-surgery | Need for reoperation as a result of interventional surgery itself or the indication for surgery |
| Mortality rate | Up to 30 days post-surgery | — |
| Length of hospital stay | Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days | Hospital stay in days from day of surgery until discharge |
| Estimated blood loss | Up to completion of surgery | Amount of blood estimated to be lost during surgery (in mL) |
Countries
Italy
Contacts
Primary ContactMark Slack, MD
Backup ContactChad Schaber, PhD
Outcome results
None listed