Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy

Gallstone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01383031
• Other study ID #: BFH-007
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 17, 2011
• Last updated: July 6, 2011
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2010
• Source: Beijing Friendship Hospital
• Contact: Yang Liu, master
• Phone: +8615001284594
• Email: liuyangzhanglina[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gallbladder Polyps
• Gallstone

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Bejing Friendship Hospital	Bejing	Bejing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	quality of life scores	Count patients' quality of life scores before sugery and at several time points after operation.	up to 12 weeks	Yes
Secondary	pain scores	Use VAS(Visual Analogue Score)to count patients' pain scores at several time points after operation.	up to 12 weeks	No
Secondary	length of hospital stay		participants will be followed for the duration of hospital stay, an expected average of 5 days	No
Secondary	total cost of hospitalization		participants will be followed for the duration of hospital stay, an expected average of 5 days	No
Secondary	Cosmetic results	Through the incision length and patients' satisfaction to assess cosmetic results.	1 month	No
Secondary	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	Yes