Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Gallstone
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- the incidence of surgical complications
- Last Updated
- 14 years ago
Overview
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 .
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 Years to 5 Years
- •Benign gallbladder diseases
- •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
Outcomes
Primary Outcomes
the incidence of surgical complications
Time Frame: 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 Outcomes
- transfer rate(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- quality of life scores(up to 12 weeks)
- pain scores(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(1 month)
- The incidence of adverse events(up to 12 weeks)