Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
NCT ID: NCT01383031
Last Updated: 2011-07-07
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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UNKNOWN
PHASE2/PHASE3
600 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
CLC
CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
TU-LESSC
TU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
TU-LESSC
TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
Interventions
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CLC
CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
TU-LESSC
TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Benign gallbladder diseases
* KPS ≥ 70
* informed consent
Exclusion Criteria
* Broadening of the common bile duct
* Gallstone pancreatitis
* Serious heart,brain,lung, metabolic diseases history
* History of upper abdominal surgery
* Pregnancy or breast-feeding women
* Refuse TU-LESSC
* BMI(Body Mass Index)≥ 30
18 Years
75 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Beijing Friendship Hospital
Principal Investigators
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Zhongtao Zhang, doctor
Role: STUDY_CHAIR
Beijing Friendship Hospital
Locations
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Bejing Friendship Hospital
Beijing, Bejing, China
Countries
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Central Contacts
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Other Identifiers
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BFH-007
Identifier Type: -
Identifier Source: org_study_id
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