Cholecystectomy Blunt Dissection

Study Overview
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Brief Summary
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Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.

Detailed Description
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After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Official Title
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Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Procedure: dissection of gallbladder in laparoscopic cholecystectomy
* Procedure: dissection of gallbladder in laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II BMI under 35 normal liver enzymes no bile duct dilatation in ultrasound cholecystolithiasis Exclusion Criteria: NSAID allergy previous upper gi-surgery common bile duct stones in preoperative imaging history of severe acute pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: conventional diathermy hook<br>Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy | Procedure: dissection of gallbladder in laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot<br>Procedure: dissection of gallbladder in laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus<br>|
| Active Comparator: 5 mm suction irrigation blunt dissection<br>Laparoscopic cholecystectomy made with 5mm suction irrigation blunt dissection starting from gallbladder fundus Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy | Procedure: dissection of gallbladder in laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot<br>Procedure: dissection of gallbladder in laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days for discharge after surgery |  | 30 days | 
| operative time |  | 30 days | 
| intraoperative bleeding amount | bleeding which require suction or draining | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of analgesic and dose |  | 30 days | 
| number of events of postoperative nausea and vomiting which require anti emetic drug |  | 30 day | 
| number of days after surgery when readmission is required |  | 30 days | 
| presence of a morbidity | number of days needed for discharge from service | 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystolithiasis, Cholelithiasis, Gallstones, Biliary Tract Diseases, Digestive System Diseases, Gallbladder Diseases, Calculi, Pathological Conditions, Anatomical