Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

Study Overview
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Brief Summary
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This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.

Detailed Description
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This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial. Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis. Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery. Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation. Cosmesis is evaluated after 28 days. Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.

Official Title
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Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain

Conditions
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Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications

Intervention / Treatment
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* Procedure: Conventional laparoscopic procedure
* Procedure: Experimental laparoscopic procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis Exclusion Criteria: Expected poor compliance History of cholecystitis or severe pancreatitis Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery

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

Sexes Eligible for Study
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Female

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4 ports laparoscopic cholecystectomy<br> | Procedure: Conventional laparoscopic procedure<br>* Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports<br>* Other names: Versaport 5 mm;|
| Other: One port transumb. laparoscopic surgery<br> | Procedure: Experimental laparoscopic procedure<br>* Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port<br>* Other names: SILS port;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on the Visual Analog Scale before surgery |  | Before surgery | 
| Pain scores on the Visual Analog Scale 3 hours after surgery |  | 3 hrs after surgery | 
| Pain scores on the Visual Analog Scale 1 day after surgery |  | 1 day after surgery | 
| Pain scores on the Visual Analog Scale 2 days after surgery |  | 2 days after surgery | 
| Pain scores on the Visual Analog Scale 3 days after surgery |  | 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea scores on a 4 point scale before surgery | The 4 point scale: none, light, moderate, and severe | Before surgery | 
| Nausea scores on a 4 point scale 3 hours after surgery | The 4 point scale: none, light, moderate, and severe | 3 hours after surgery | 
| Nausea scores on a 4 point scale 1 day surgery | The 4 point scale: none, light, moderate, and severe | 1 day after surgery | 
| Nausea scores on a 4 point scale 2 days after surgery | The 4 point scale: none, light, moderate, and severe | 2 days after surgery | 
| Nausea scores on a 4 point scale 3 days after surgery | The 4 point scale: none, light, moderate, and severe | 3 days after surgery | 
| Well being scores on the Visual Analog Scale before surgery |  | Before surgery | 
| Well being scores on the Visual Analog Scale 3 hours after surgery |  | 3 hours after surgery | 
| Well being scores on the Visual Analog Scale 1 day after surgery |  | 1 day after surgery | 
| Well being scores on the Visual Analog Scale 2 days after surgery |  | 2 days after surgery | 
| Well being scores on the Visual Analog Scale 3 days after surgery |  | 3 days after surgery | 
| Number of participants with adverse events as a measure of safety and tolerability | Adverse events include all complications related to surgery | Within 30 days after surgery | 
| Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery |  | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single site surgery, laparoscopic surgery, pain, nausea