A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy

Gallbladder Polyp Clinical Trial

Official title:

A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185586
• Other study ID #: 2014-21
• Secondary ID: 2014-21
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2020
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).

We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age from 18 to 70 years old

• benign diseases of gallbladder

• selective cholecystectomy

• Capable to read and write

Exclusion Criteria:

• accept upper abdominal operation before

• acute cholecystitis

• with serious heart or pulmonary diseases

• with diseases of immune system

• Pregnant women

• can not understand the research purposes

• relatives of researchers

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Polyp
• Gallbladder Stone
• Gallstones

Intervention

Procedure:
• laparoscopic cholecystectomy

Locations

Country	Name	City	State
China	Department of hepatobiliary surgery,China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	perioperative indexes	operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay	perioperative period
Primary	Systematic inflammatory response caused by the surgical trauma	Blood IL-6,TNF-a,and CRP levels determined by ELISA at different time-points,	one day before the operation,8 hours after the operation,one day after the operation
Secondary	Cosmesis and body image score		1 and 3 months after the operation
Secondary	pulmonary function		one day before the operation, one day after the operation
Secondary	Post-operation pain score (visual analog scale, VAS)		12 and 24 hours after the operation
Secondary	36-item health survey		3 months after the operation