Back to resultsA Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
Primary Purpose
Gallbladder Stone, Gallbladder Polyp
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Stone
Eligibility Criteria
Inclusion Criteria:
- age from 18 to 70 years old
- benign diseases of gallbladder
- selective cholecystectomy
- Capable to read and write
Exclusion Criteria:
- 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
Sites / Locations
- Department of hepatobiliary surgery,China-Japan Friendship Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
LALC
SLC
UALC
Arm Description
lower abdominal laparoscopic cholecystectomy
single laparoscopic cholecystectomy
upper abdominal laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
Systematic inflammatory response caused by the surgical trauma
Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
Secondary Outcome Measures
Cosmesis and body image score
pulmonary function
Post-operation pain score (visual analog scale, VAS)
36-item health survey
Full Information
NCT ID
NCT02185586
First Posted
July 6, 2014
Last Updated
January 21, 2020
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02185586
Brief Title
A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
Official Title
A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Stone, Gallbladder Polyp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LALC
Arm Type
Experimental
Arm Description
lower abdominal laparoscopic cholecystectomy
Arm Title
SLC
Arm Type
Experimental
Arm Description
single laparoscopic cholecystectomy
Arm Title
UALC
Arm Type
Placebo Comparator
Arm Description
upper abdominal laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Other Intervention Name(s)
lower abdominal three-port laparoscopic cholecystectomy, single port laparoscopic cholecystectomy, upper abdominal three-port laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Systematic inflammatory response caused by the surgical trauma
Description
Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
Time Frame
one day before the operation,8 hours after the operation,one day after the operation
Secondary Outcome Measure Information:
Title
Cosmesis and body image score
Time Frame
1 and 3 months after the operation
Title
pulmonary function
Time Frame
one day before the operation, one day after the operation
Title
Post-operation pain score (visual analog scale, VAS)
Time Frame
12 and 24 hours after the operation
Title
36-item health survey
Time Frame
3 months after the operation
Other Pre-specified Outcome Measures:
Title
perioperative indexes
Description
operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay
Time Frame
perioperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age from 18 to 70 years old
benign diseases of gallbladder
selective cholecystectomy
Capable to read and write
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Wang, MD
Organizational Affiliation
China-Japan Friednship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of hepatobiliary surgery,China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
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