The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively

Detailed Description
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Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery. Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.

Official Title
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The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Conditions
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Gallbladder Disease

Intervention / Treatment
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* Procedure: SILS cholecystectomy
* Procedure: TPCL cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Required laparoscopic cholecystectomy for gallbladder disease. Exclusion Criteria: American Society of Anesthesiologists score (ASA) more than III, Patients had prior abdominal surgery, Patients admitted outside working hours with acute cholecystitis, Patients have choledocolithiasis, pregnancy, ongoing peritoneal dialysis, lack of written informed consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Group 1<br>SILS cholecystectomy | Procedure: SILS cholecystectomy<br>* Single incision laparoscopic cholecystectomy will be performed<br>|
| Active Comparator: Group 2<br>TPCL cholecystectomy | Procedure: TPCL cholecystectomy<br>* Three port laparoscopic cholecystectomy will br performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared. | Postoperative first 24 hours | 
| Intraoperative complications | Per operative complications will be recorded. Bleeding Gallbladder perforation Bile leakage Bowel perforation Complications associated with increased intra-abdominal pressure | Average of 70 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | The operating time will be defined as the time from the first incision to the last suture's placement. | Average of 70 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single incision, cholecystectomy, laparoscopy