Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

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. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic 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 anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Official Title
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Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial

Conditions
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Cholecystolithiasis

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 | Procedure: dissection of gallbladder in laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot<br>|
| Active Comparator: ultrasonic dissection<br>Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus | Procedure: dissection of gallbladder in laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy with ultrasonic scissors starting from fundus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| same day discharge |  | 30 days | 
| operative time |  | 30 days | 
| intraoperative complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgetic use |  | 30 days | 
| postoperative nausea and vomiting |  | 30 days | 
| readmission |  | 30 days | 
| morbidity |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic cholecystectomy