Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain

Study Overview
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Brief Summary
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This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Detailed Description
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The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures. Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies. The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
* Procedure: Four port laparoscopic cholecystectomy surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biliary cholic Biliary dyskinesia Gallbladder polyps Other diagnosis at the discretion of the surgeon Exclusion Criteria: History of Acute cholecystitis Jaundice Choledocolithiasis History of Pancreatitis Severe comorbidity BMI > 30

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single port laparoscopic device<br> | Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)<br>* Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)<br>* Other names: One-trocar cholecistectomy;|
| Active Comparator: Four-port laparoscopic device<br> | Procedure: Four port laparoscopic cholecystectomy surgery<br>* Four port laparoscopic cholecystectomy surgery<br>* Other names: traditional Laparoscopic cholecistectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain scores (visual analogue pain scale from 0-10) |  | Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-assessed cosmesis on the Visual Analogue Scale |  | 30 days after surgery | 

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