Safety and performance evaluation of the AutoLap system - a feasibility study
Completed
- Conditions
- cholecystolithiasiscolectomiegallstoneshernia repairNissen fundoplication1001801210017998
- Registration Number
- NL-OMON39368
- Lead Sponsor
- Medical Surgical technologies ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Patients between 18 and 85 years of age who were scheduled for elective laparoscopic procedures: cholecystectomy, hernia repair, right colectomy, Nissen fundoplication and sigmoid resection
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Performance Evaluation:<br /><br>- The ability of the AutoLap system to successfully move the laparoscope to the<br /><br>surgeon's desired position. Success is defined as bringing the laparoscope to<br /><br>the desired position in at least 85% of the required movements.<br /><br><br /><br>Parameters that relate to the performance of an endoscope during endoscopic<br /><br>surgery<br /><br>1) System set-up time recording<br /><br>2) Average total procedure time recording<br /><br>3) Number of times that the laparoscope was removed for cleaning.<br /><br>4) Usability - the AutoLap system usability in laparoscopic procedures will be<br /><br>assessed by a questionnaire.<br /><br><br /><br><br /><br>.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety Evaluation:<br /><br><br /><br>1) No conversion to open surgery from laparoscopic surgery due to using the<br /><br>AutoLap system.<br /><br>2) No AutoLap system related operative complications that require further<br /><br>clinical intervention. </p><br>