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Single Incision Laparoscopic Cholecystectomy (SILC)

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Single Incision Laparoscopic Cholecystectomy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring Single Incision, Single Access, Surgery, Cholecystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UT Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical group

Arm Description

Patients with ultrasound proven symptomatic cholelithiasis (gallstones).

Outcomes

Primary Outcome Measures

Safety and feasibility

Secondary Outcome Measures

Short-term clinical outcomes

Full Information

First Posted
May 14, 2008
Last Updated
December 14, 2009
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00678873
Brief Title
Single Incision Laparoscopic Cholecystectomy
Acronym
SILC
Official Title
Single Incision Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Single Incision, Single Access, Surgery, Cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical group
Arm Type
Experimental
Arm Description
Patients with ultrasound proven symptomatic cholelithiasis (gallstones).
Intervention Type
Procedure
Intervention Name(s)
Single Incision Laparoscopic Cholecystectomy
Other Intervention Name(s)
Single incision surgery, Single access surgery, Single incision laparoscopy, Single access laparoscopy, Laparoscopic cholecystectomy, Single access laparoscopic cholecystectomy, Cholecystectomy
Intervention Description
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Primary Outcome Measure Information:
Title
Safety and feasibility
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Short-term clinical outcomes
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Homero Rivas, MD
Organizational Affiliation
UTSouthwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Single Incision Laparoscopic Cholecystectomy

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