Cholelithiasis
Conditions
Keywords
Cholecystectomy, Cholecystectomy, Laparoscopic, Laparoscopy
Brief summary
The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.
Interventions
DEVICEGallbladder retraction
The gallbladder will be retracted using the Endograb retractor
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic cholelithiasis * Age 18-60 * ASA 1-2 * Able to sign an informed consent
Exclusion criteria
* ASA 3 or more * Acute cholecystitis * Choledocholithiasis * Coagulation disorders * Patients on blood thinners * Use of Steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome will be either success or failure. Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| No adverse effects related directly to the use of the Endograb retractor. | 1 year |
Countries
Israel
Outcome results
None listed