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Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

Primary Purpose

Gallstone, Gallbladder Polyps

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CLC
TU-LESSC
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstone focused on measuring laparoscopic cholecystectomy, single site, randomized controlled trail

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bejing Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic Cholecystectomy

TU-LESSC

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

transfer rate
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
Count patients' quality of life scores before sugery and at several time points after operation.
pain scores
Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation.
length of hospital stay
total cost of hospitalization
Cosmetic results
Through the incision length and patients' satisfaction to assess cosmetic results.
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.

Full Information

First Posted
June 17, 2011
Last Updated
July 6, 2011
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01383031
Brief Title
Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
Official Title
Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone, Gallbladder Polyps
Keywords
laparoscopic cholecystectomy, single site, randomized controlled trail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Cholecystectomy
Arm Type
Active Comparator
Arm 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.
Arm Title
TU-LESSC
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
CLC
Other Intervention Name(s)
conventional laparoscopic cholecystectomy
Intervention Description
CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
Intervention Type
Procedure
Intervention Name(s)
TU-LESSC
Other Intervention Name(s)
Transumbilical laparoendoscopic single site cholecystectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of surgical complications
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
transfer rate
Description
TU-LESSC（transumbilical laparoendoscopic single site cholecystectomy）is converted to LC（laparoscopic cholecystectomy）or open sugery;LC is converted to open sugery.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
quality of life scores
Description
Count patients' quality of life scores before sugery and at several time points after operation.
Time Frame
up to 12 weeks
Title
pain scores
Description
Use VAS（Visual Analogue Score）to count patients' pain scores at several time points after operation.
Time Frame
up to 12 weeks
Title
length of hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
total cost of hospitalization
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Cosmetic results
Description
Through the incision length and patients' satisfaction to assess cosmetic results.
Time Frame
1 month
Title
The incidence of adverse events
Description
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.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Liu, master
Phone
+8615001284594
Email
liuyangzhanglina@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo, doctor
Phone
+8613910950019
Email
guoweipk@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongtao Zhang, doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bejing Friendship Hospital
City
Bejing
State/Province
Bejing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Z Tao, Doctor

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

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