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Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01383031
Recruitment Status : Unknown
Verified October 2010 by Beijing Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : June 28, 2011
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
Beijing Friendship Hospital

Tracking Information
First Submitted Date  ICMJE June 17, 2011
First Posted Date  ICMJE June 28, 2011
Last Update Posted Date July 7, 2011
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01383031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
  • transfer rate [ Time Frame: 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 [ Time Frame: up to 12 weeks ]
    Count patients' quality of life scores before sugery and at several time points after operation.
  • pain scores [ Time Frame: up to 12 weeks ]
    Use VAS(Visual Analogue Score)to count patients' pain scores at several time points after operation.
  • length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • total cost of hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Cosmetic results [ Time Frame: 1 month ]
    Through the incision length and patients' satisfaction to assess cosmetic results.
  • The incidence of adverse events [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
  • transfer rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    TU-LESSC is converted to LC or open sugery;LC is converted to open sugery.
  • quality of life scores [ Time Frame: up to 12 weeks ]
    Count patients' quality of life scores before sugery and at several time points after operation.
  • pain scores [ Time Frame: up to 12 weeks ]
    Use VAS to count patients' pain scores at several time points after operation.
  • length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • total cost of hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Cosmetic results [ Time Frame: 1 month ]
    Through the incision length and patients' satisfaction to assess cosmetic results.
  • The incidence of adverse events [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
Official Title  ICMJE Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Gallstone
  • Gallbladder Polyps
Intervention  ICMJE
  • 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 Name: conventional laparoscopic cholecystectomy
  • 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 Name: Transumbilical laparoendoscopic single site cholecystectomy
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: CLC
  • 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.
    Intervention: Procedure: TU-LESSC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 24, 2011)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01383031
Other Study ID Numbers  ICMJE BFH-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Friendship Hospital
Study Sponsor  ICMJE Beijing Friendship Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhongtao Zhang, doctor Beijing Friendship Hospital
PRS Account Beijing Friendship Hospital
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP