Single Incision Laparoscopic Cholecystectomy (SILC)

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Cholelithiasis

Treatments: Procedure: Single Incision Laparoscopic Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00678873

8843

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Surgical group

Experimental group

Description:

Patients with ultrasound proven symptomatic cholelithiasis (gallstones).

Treatment:

Procedure: Single Incision Laparoscopic Cholecystectomy