Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgical group
Patients with ultrasound proven symptomatic cholelithiasis (gallstones).
Single Incision Laparoscopic Cholecystectomy
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Interventions
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Single Incision Laparoscopic Cholecystectomy
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of giving informed consent
* Ultrasound proven cholelithiasis
* Symptomatic cholelithiasis
* Elective cholecystectomy
Exclusion Criteria
* Contraindications for general anesthesia
* Morbid obesity
* Multiple previous abdominal surgeries
* Uncontrolled medical conditions
* Acute cholecystitis
18 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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UT Southwestern
Principal Investigators
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Homero Rivas, MD
Role: PRINCIPAL_INVESTIGATOR
UTSouthwestern
Locations
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UT Southwestern
Dallas, Texas, United States
Countries
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Other Identifiers
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8843
Identifier Type: -
Identifier Source: org_study_id