Safety and performance evaluation of the AutoLap system - a feasibility study

Safety and performance evaluation of the AutoLap system - a feasibility study - Safety and performance of the AutoLap system

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39368

Enrollment

Registered

2012-12-18

Start date

2014-01-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholecystolithiasis colectomie gallstones hernia repair Nissen fundoplication

Interventions

Laparoscopic cholecystectomy, hernia repair, right colectomy, Nissen fundoplication and sigmoidresection conform national guidelines

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Performance Evaluation: - The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position. Success is defined as bringing the laparoscope to the desired position in at least 85% of the required movements. Parameters that relate to the performance of an endoscope during endoscopic surgery 1) System set-up time recording 2) Average total procedure time recording 3) Number of times that the laparoscope was removed for cleaning. 4) Usability - the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire. .	—

Measure

Time frame

Performance Evaluation: - The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position. Success is defined as bringing the laparoscope to the desired position in at least 85% of the required movements. Parameters that relate to the performance of an endoscope during endoscopic surgery 1) System set-up time recording 2) Average total procedure time recording 3) Number of times that the laparoscope was removed for cleaning. 4) Usability - the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire. .

—

Secondary

Measure	Time frame
Safety Evaluation: 1) 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)