Drainage or Not for Laparoscopic Cholecystetomy

Study Overview
=================
Brief Summary
-----------------
Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.

Detailed Description
-----------------
The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage. Compare complications as below betwwen drainage and no drainage groups. VAS Nause and vomiting infection bleeding bile leakage puncture drainage readmission reoperation hospital stay hospital expense

Official Title
-----------------
Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study

Conditions
-----------------
Cholecystitis, Cholecystolithiasis, Polyps Gallbladder, Adenomyosis of Gallbladder

Intervention / Treatment
-----------------
* Procedure: drainage tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age:18-75 years old indicated and planed to receive laparoscopic cholecystectomy Exclusion Criteria: cirrohosis Child Grading B and C upper abdominal surgery history adjustment of surgical name intraoperative

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drainage<br>Placement of subhepatic drainage tube for laparoscopic cholecytetomy | Procedure: drainage tube<br>* sub-hepatic drainage tube for laparoscopic cholecystectomy<br>|
| No Intervention: no drainage<br>no placement of subhepatic drainage tube for laparoscopic cholecytetomy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding Bile leakage | the morbidity of bleeding the morbidity of bile leakage | day 1 to one month post LC operation | 
| bile leakage | the morbidity of bile leakage | day 1 to one month post LC operation | 
| Puncture drainage Puncture drainage | the percentage of puncture drainage Puncture drainage Puncture drainage | day 1 to one month post LC operation | 
| reoperation Reoperation | the percentage of reoperation | day 1 to one month post LC operation | 
| readmission | the percentage of readmission | day 1 to one month post LC operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | hospital stay | day 1 to discharge post LC operation | 
| Hospitalization expenses | Hospitalization expenses | day 1 to discharge post LC operation | 
| VAS score | VAS score | day 1 to discharge post LC operation | 
| Nausea and vomiting | the morbidity of Nausea and vomiting | day 1 to discharge post LC operation | 
| infection | the morbidity of infection (abdominal, incision,pulmonary,et al) | day 1 to discharge post LC operation |