Cholelithiasis
Conditions
Keywords
Single Incision, Single Access, Surgery, Cholecystectomy
Brief summary
The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy. The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
Detailed description
Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction. In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).
Interventions
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults male and female(\>18 years old) * Capable of giving informed consent * Ultrasound proven cholelithiasis * Symptomatic cholelithiasis * Elective cholecystectomy
Exclusion criteria
* Pregnancy * Contraindications for general anesthesia * Morbid obesity * Multiple previous abdominal surgeries * Uncontrolled medical conditions * Acute cholecystitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Short-term clinical outcomes | 12 months |
Countries
United States
Outcome results
None listed