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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02185586

Enrollment

105

Registered

2014-07-09

Start date

2014-05-31

Completion date

2015-11-30

Last updated

2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder Polyp, Gallbladder Stone

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.

Interventions

PROCEDURElaparoscopic cholecystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Other

Measure	Time frame	Description
perioperative indexes	perioperative period	operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026