A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy

Conditions
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Gallbladder Stone, Gallbladder Polyp

Intervention / Treatment
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* Procedure: laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LALC<br>lower abdominal laparoscopic cholecystectomy | Procedure: laparoscopic cholecystectomy<br> <br> * Other names: upper abdominal three-port laparoscopic cholecystectomy;|
| Experimental: SLC<br>single laparoscopic cholecystectomy | Procedure: laparoscopic cholecystectomy<br> <br> * Other names: upper abdominal three-port laparoscopic cholecystectomy;|
| Placebo Comparator: UALC<br>upper abdominal laparoscopic cholecystectomy | Procedure: laparoscopic cholecystectomy<br> <br> * Other names: upper abdominal three-port laparoscopic cholecystectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operation pain score (visual analog scale, VAS) |  | 12 and 24 hours after the operation | 
| 36-item health survey |  | 3 months after the operation | 
| Cosmesis and body image score |  | 1 and 3 months after the operation | 
| pulmonary function |  | one day before the operation, one day after the operation |