Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Beijing Friendship Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01383031
First received: June 17, 2011
Last updated: July 6, 2011
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Gallstone
Gallbladder Polyps
Procedure: CLC
Procedure: TU-LESSC
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • the incidence of surgical complications [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    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:
  • transfer rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Count patients' quality of life scores before sugery and at several time points after operation.

  • pain scores [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • total cost of hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
  • Cosmetic results [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Through the incision length and patients' satisfaction to assess cosmetic results.

  • The incidence of adverse events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 600
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 .

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383031

Contacts
Contact: Yang Liu, master +8615001284594 liuyangzhanglina@163.com
Contact: Wei Guo, doctor +8613910950019 guoweipk@yahoo.com.cn

Locations
China, Bejing
Bejing Friendship Hospital Recruiting
Bejing, Bejing, China, 100050
Principal Investigator: Zhang Z Tao, Doctor         
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
Study Chair: Zhongtao Zhang, doctor Beijing Friendship Hospital
  More Information

No publications provided

Responsible Party: Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01383031     History of Changes
Other Study ID Numbers: BFH-007
Study First Received: June 17, 2011
Last Updated: July 6, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Friendship Hospital:
laparoscopic cholecystectomy
single site
randomized controlled trail

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 27, 2014