Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Gallstone; Gallbladder Polyps
• Intervention / Treatment: Procedure: CLC; Procedure: TU-LESSC

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Bejing
    • Bejing, Bejing, China, 100050
      • Recruiting
      • Bejing Friendship Hospital
      • Principal Investigator: Zhang Z Tao, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Cholecystectomy; 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; CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.; Other Names: conventional laparoscopic cholecystectomy
Active Comparator: 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.	Procedure: TU-LESSC; 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.; Other Names: Transumbilical laparoendoscopic single site cholecystectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Study Chair: Zhongtao Zhang, Doctor, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; single site; randomized controlled trail
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Gallstones
• Other Study ID Numbers: BFH-007