Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
1 other identifier
interventional
600
1 country
1
Brief Summary
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 7, 2011
October 1, 2010
2.2 years
June 17, 2011
July 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of surgical complications
The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation.
up to 12 weeks
Secondary Outcomes (7)
transfer rate
participants will be followed for the duration of hospital stay, an expected average of 5 days
quality of life scores
up to 12 weeks
pain scores
up to 12 weeks
length of hospital stay
participants will be followed for the duration of hospital stay, an expected average of 5 days
total cost of hospitalization
participants will be followed for the duration of hospital stay, an expected average of 5 days
- +2 more secondary outcomes
Study Arms (2)
Laparoscopic Cholecystectomy
ACTIVE COMPARATORLaparoscopic cholecystectomy（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
ACTIVE COMPARATORTU-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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Years to 5 Years
- Benign gallbladder diseases
- KPS ≥ 70
- informed consent
You may not qualify if:
- Obstructive jaundice
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bejing Friendship Hospital
Beijing, Bejing, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhongtao Zhang, doctor
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 28, 2011
Study Start
October 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 7, 2011
Record last verified: 2010-10