Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
Conditions
Keywords
laparoscopic Cholecystectomy, Gallbladder removal, laparoscope holder
Brief summary
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
Interventions
DEVICEactive laparoscope positioner (AutoLap)
Sponsors
M.S.T. Medical Surgery Technology LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated Informed Consent Form. 2. Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Exclusion criteria
1. Previous upper abdominal surgery and contraindications to Pneumoperitoneum. 2. Pregnancy. 3. Obesity (BMI \>35 Kg/m2). 4. Generalized peritonitis. 5. Septic shock from cholangitis. 6. Severe acute pancreatitis. 7. Uncorrected coagulopathy. 8. Previous abdominal operations which prevent safe abdominal access or progression of the procedure. 9. Advanced cirrhosis with failure of hepatic function. 10. Suspected gallbladder cancer. 11. Acute cholecystitis 12. Presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study. 13. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | participants will be followed for the duration of hospital stay, an expected average of 1-2 days | No conversion to open surgery from laparoscopic surgery due to using the AutoLap system 2) No AutoLap system related operative complications, that require further clinical intervention |
| Performance evaluation | during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| system set-up time | during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | defined as the time required from connecting the AutoLap's ARM to the bed rail |
| Average total procedure time | during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | defined as the time from first abdominal incision until the surgical procedure is completed |
| Number of times that the laparoscope was removed for cleaning | During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). | — |
| Usability evaluation | During surgery (at the end of the procedure) | the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire. The questionnaire assesses the surgeon's satisfaction with the use of the AutoLap in regard to easiness of use, convenient of movement control and its ability to be used in the OR without interfering with the surgical flow |
Countries
Israel, Italy, Netherlands
Outcome results
None listed