The main objectives of this study are to evaluate the safety and performance of the AutoLap system in the following laparoscopic procedures: hernia repair, cholecystectomy, right colectomy, Nissen fundoplication and sigmoidresection. The AutoLap…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
During Laparoscopic treatment of surgical diseases an assistant is typically
required to hold and position the camera according to the commands of the
surgeon.
The assistant*s ability to anticipate the next camera placement is not always
optimal, and communication problems occasionally occur. Holding the camera may
also be exhausting in long surgical procedures, leading to fatigue and,
potentially, unsteady images. Furthermore, depth perception may be impaired
when the surgeon is not directing the camera.
MST has developed the AutoLap system, an active laparoscope positioner. The
AutoLap system is designed to hold and position the laparoscope during
laparoscopic surgery. When the camera is in position, the AutoLap system holds
the laparoscope steady as with any laparoscopic positioner. To maneuver the
laparoscope to the desired position, the surgeon presses a single button, which
is affixed to his hand or to the surgical instrument.
Study objective
The main objectives of this study are to evaluate the safety and performance of
the AutoLap system in the following laparoscopic procedures: hernia repair,
cholecystectomy, right colectomy, Nissen fundoplication and sigmoidresection.
The AutoLap system will be evaluated in Smart Joystick mode.
Study design
Prospective, single arm (non-randomized), multicenter study involving up to 40
subjects in The Netherlands, Israel and Italy, who are planned for the
following laparoscopic procedures: hernia repair, cholecystectomy, right
colectomy, Nissen fundoplication and sigmoidresection.
Intervention
Laparoscopic cholecystectomy, hernia repair, right colectomy, Nissen
fundoplication and sigmoidresection conform national guidelines
Study burden and risks
Minimal/theoretical: damage to internal organs due to unexpected or rude
movements of the endoscope
potential benefits:
The AutoLap system is designed to enable full control of the surgeon on the
desired field of view and of the surgical procedure, thus eliminating the
limitation of dis-coordination between the surgeon and the camera holder,
possibly providing an image which is more stable, and the ability to maximize
the efficacy of the operation room personnel.
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Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41349.100.12 |