Laparoscopic Cholecystectomy
Conditions
Brief summary
This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.
Detailed description
The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of lower pneumoperitoneal pressures whilst maintaining an adequate visual field throughout the procedure with low demand for CO2 replenishment to maintain pneumoperitoneal pressure. Comparisons in terms of surgical field visualization, procedure times, and CO2 consumption will be conducted in order to determine whether or not any clinical benefits are derived from the use of the Ultravision™ System compared to the Airseal® iFS. Low pressure laparoscopy for this study is set at 10mmHg. This is a prospective, open-label, randomized controlled study. The study will include two study arms. Patients undergoing laparoscopic cholecystectomy will be randomized to either Ultravision (study arm 1) or Airseal® iFS (study arm 2). Both groups will conduct the procedure at 10mmHg, considered to be low pressure/low impact laparoscopic surgery. The study will enroll 30 patients, 15 per group. Both devices are being used according to their cleared label claims.
Interventions
DEVICESmoke management during laparoscopic cholecystectomy using the Ultravision™ System
The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.
DEVICESmoke management during laparoscopic cholecystectomy using the Airseal® iFS
The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.
Sponsors
Alesi Surgical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is 18 years or older * Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure * Agrees to attend all follow-up assessments * Is indicated for elective laparoscopic cholecystectomy
Exclusion criteria
* Existing comorbidities that would contraindicate them for laparoscopic surgery * Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively * Body Mass Index \> 50 * Be pregnant (if female) * Has a condition of unrelated chronic pain requiring medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carbon Dioxide Utilization | Measured from Veress needle insertion to just prior to gall bladder removal | The volume measured in Liters of Carbon Dioxide consumed during the procedure |
| Quality of Visualization | Measured from camera insertion through removal | The quality of visualization in the laparoscopic field |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Medications | 1 to 7 days post procedure | Amount and type of pain medication administered and record of use following the procedure |
| Procedure Time | Measured from the insertion of the camera to the time of closure | Overall procedure time in minutes |
| End tidal CO2 Volume | Measured at Veress needle insertion and just prior to gall bladder removal | End tidal volume of CO2 |
| Laparoscope cleaning | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | The number of times during the procedure that the laparoscope must be removed for cleaning to maintain visual field |
| Procedure time for Diathermy use | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | Measures the procedure time in minutes where diathermy is used |
| Trocar Venting | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | The number of times the trocar is used to vent during the procedure for visualization |
| Case Complexity | Immediately post-procedure | Case complexity compared to surgeon experience. Recorded as simple or routine or complex/difficult. |
| Pain Assessment | Pre-procedure and 1 to 7 days post procedure | Pre and Post operative pain surveys |
| Pneumoperitoneum Pressure | Starting pneumoperitoneum pressure at the time of camera trocar insertion, record the maximum pressure that occurred during the procedure | The pneumoperitoneum pressure during the procedure and record of any increase beyond 10mmHg for visualization |
| Diathermy Power Setting | Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy | Highest diathermy setting used during the procedure |
Countries
United States
Contacts
Primary ContactJin S Yoo, MD
Outcome results
None listed