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

China-Japan Friendship Hospital

Status: Completed

Conditions: Gallbladder Polyp; Gallbladder Stone

Treatments: Procedure: laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02185586

2014-21 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups, including a placebo group

LALC

Experimental group

Description:

lower abdominal laparoscopic cholecystectomy

Treatment:

Procedure: laparoscopic cholecystectomy

SLC

Experimental group

Description:

single laparoscopic cholecystectomy

Treatment:

Procedure: laparoscopic cholecystectomy

UALC

Placebo Comparator group

Description:

upper abdominal laparoscopic cholecystectomy

Treatment:

Procedure: laparoscopic cholecystectomy