Single Incision Laparoscopic Cholecystectomy
- Conditions
- Cholelithiasis
- Interventions
- Procedure: Single Incision Laparoscopic Cholecystectomy
- Registration Number
- NCT00678873
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Adults male and female(>18 years old)
- Capable of giving informed consent
- Ultrasound proven cholelithiasis
- Symptomatic cholelithiasis
- Elective cholecystectomy
- Pregnancy
- Contraindications for general anesthesia
- Morbid obesity
- Multiple previous abdominal surgeries
- Uncontrolled medical conditions
- Acute cholecystitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgical group Single Incision Laparoscopic Cholecystectomy Patients with ultrasound proven symptomatic cholelithiasis (gallstones).
- Primary Outcome Measures
Name Time Method Safety and feasibility 12 months
- Secondary Outcome Measures
Name Time Method Short-term clinical outcomes 12 months
Trial Locations
- Locations (1)
UT Southwestern
🇺🇸Dallas, Texas, United States