Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.

Detailed Description
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As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .

Official Title
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Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

Conditions
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Gallstone, Gallbladder Polyps

Intervention / Treatment
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* Procedure: CLC
* Procedure: TU-LESSC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years to 5 Years Benign gallbladder diseases KPS ≥ 70 informed consent Exclusion Criteria: Obstructive jaundice Broadening of the common bile duct Gallstone pancreatitis Serious heart,brain,lung, metabolic diseases history History of upper abdominal surgery Pregnancy or breast-feeding women Refuse TU-LESSC BMI(Body Mass Index)≥ 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 |
| --- | --- |
| Active Comparator: Laparoscopic Cholecystectomy<br>Laparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy. | Procedure: CLC<br>* CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.<br>* Other names: conventional laparoscopic cholecystectomy;|
| Active Comparator: TU-LESSC<br>TU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments. | Procedure: TU-LESSC<br>* TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.<br>* Other names: Transumbilical laparoendoscopic single site cholecystectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of surgical complications | The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfer rate | TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery. | participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| quality of life scores | Count patients' quality of life scores before sugery and at several time points after operation. | up to 12 weeks | 
| pain scores | Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation. | up to 12 weeks | 
| length of hospital stay |  | participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| total cost of hospitalization |  | participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Cosmetic results | Through the incision length and patients' satisfaction to assess cosmetic results. | 1 month | 
| The incidence of adverse events | The adverse events occurred after surgery，regardless of whether they are caused by the tow operations。 Such as nausea, dizziness, urinary retention, vomiting and so on. | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic cholecystectomy, single site, randomized controlled trail