Single Incision Laparoscopic Cholecystectomy Compared With Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study

Study Overview
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Brief Summary
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Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.

Official Title
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Single Incision Laparoscopic Cholecystectomy Compared With Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study

Conditions
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Cholecystectomy, Laparoscopic

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Benign gallbladder disease Exclusion Criteria: Combined with liver cirrhosis (Child grade B and above) Upper abdominal surgical history; Gallbladder gangrene perforation; Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.) patients and their families do not agree with the treatment lost follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-incision laparoscopic cholecystectomy<br>SILC was defined as laparoscopic surgery done through a single trans-umbilical incision | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.<br>|
| Active Comparator: Conventional laparoscopic cholecystectomy<br>CLC was defined as three or four port surgery carried out with either French or American position. | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (time to return to normal life) | The quality of life of patients after operation was investigated by a unified SF-36 questionnaire. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic result | Evaluation of postoperative incisional scarring using the Vancouver Scar Scale | 2 years | 
| Grade II or above incidence of complications |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-incision laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy