Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
- Conditions
- GallstoneGallbladder Polyps
- Interventions
- Procedure: CLCProcedure: TU-LESSC
- Registration Number
- NCT01383031
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
- Detailed Description
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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 18 Years to 5 Years
- Benign gallbladder diseases
- KPS ≥ 70
- informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic Cholecystectomy CLC 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. TU-LESSC TU-LESSC 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.
- Primary Outcome Measures
Name Time Method the incidence of surgical complications up to 12 weeks 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.
- Secondary Outcome Measures
Name Time Method transfer rate participants will be followed for the duration of hospital stay, an expected average of 5 days TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery.
quality of life scores up to 12 weeks Count patients' quality of life scores before sugery and at several time points after operation.
pain scores up to 12 weeks Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation.
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 1 month Through the incision length and patients' satisfaction to assess cosmetic results.
The incidence of adverse events up to 12 weeks 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.
Trial Locations
- Locations (1)
Bejing Friendship Hospital
🇨🇳Bejing, Bejing, China