- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00678873
Single Incision Laparoscopic Cholecystectomy (SILC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Surgical group
Patients with ultrasound proven symptomatic cholelithiasis (gallstones).
|
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and feasibility
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Short-term clinical outcomes
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Homero Rivas, MD, UTSouthwestern
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8843
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National University Hospital, SingaporeCompletedPancreatitis | Cholangitis | Cholelithiasis | Cholecystolithiasis | CholedocholithiasisSingapore
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Saint Luke's Health SystemTyco Healthcare Group LP (d/b/a Covidien)TerminatedCholecystitis | Biliary Dyskinesia | Gallstones | CholelithiasisUnited States
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Kantonsspital Winterthur KSWUnknownBenign Gallbladder DiseaseSwitzerland
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G. Hatzikosta General HospitalCompletedInflammatory Response | CholelithiasisGreece
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Mansoura UniversityUnknown