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

Not Applicable

Completed

• Conditions: Gallbladder Stone; Gallbladder Polyp
• Interventions: Procedure: laparoscopic cholecystectomy

• Registration Number: NCT02185586
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-06
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLC	laparoscopic cholecystectomy	single laparoscopic cholecystectomy
UALC	laparoscopic cholecystectomy	upper abdominal laparoscopic cholecystectomy
LALC	laparoscopic cholecystectomy	lower abdominal laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Systematic inflammatory response caused by the surgical trauma	one day before the operation,8 hours after the operation,one day after the operation	Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,

Secondary Outcome Measures

Name	Time	Method
36-item health survey	3 months after the operation
pulmonary function	one day before the operation, one day after the operation
Cosmesis and body image score	1 and 3 months after the operation
Post-operation pain score (visual analog scale, VAS)	12 and 24 hours after the operation

Trial Locations

Locations (1)

Department of hepatobiliary surgery,China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China