Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

Capital Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gallstone; Gallbladder Polyps

Treatments: Procedure: CLC; Procedure: TU-LESSC

Study type: Interventional

Funder types: Other

Identifiers

NCT01383031

BFH-007

Details and patient eligibility

About

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

Full 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 .

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Laparoscopic Cholecystectomy

Active Comparator group

Description:

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.

Treatment:

Procedure: CLC

TU-LESSC

Active Comparator group

Description:

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.

Treatment:

Procedure: TU-LESSC