A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
1 other identifier
interventional
105
1 country
1
Brief Summary
We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus). We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
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
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 6, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 23, 2020
January 1, 2020
1.3 years
July 6, 2014
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Systematic inflammatory response caused by the surgical trauma
Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
one day before the operation,8 hours after the operation,one day after the operation
Secondary Outcomes (4)
Cosmesis and body image score
1 and 3 months after the operation
pulmonary function
one day before the operation, one day after the operation
Post-operation pain score (visual analog scale, VAS)
12 and 24 hours after the operation
36-item health survey
3 months after the operation
Other Outcomes (1)
perioperative indexes
perioperative period
Study Arms (3)
LALC
EXPERIMENTALlower abdominal laparoscopic cholecystectomy
SLC
EXPERIMENTALsingle laparoscopic cholecystectomy
UALC
PLACEBO COMPARATORupper abdominal laparoscopic cholecystectomy
Interventions
Eligibility Criteria
You may qualify if:
- age from 18 to 70 years old
- benign diseases of gallbladder
- selective cholecystectomy
- Capable to read and write
You may not qualify if:
- accept upper abdominal operation before
- acute cholecystitis
- with serious heart or pulmonary diseases
- with diseases of immune system
- Pregnant women
- can not understand the research purposes
- relatives of researchers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of hepatobiliary surgery,China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Wang, MD
China-Japan Friednship Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of hepatobiliary surgery
Study Record Dates
First Submitted
July 6, 2014
First Posted
July 9, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
January 23, 2020
Record last verified: 2020-01