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The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument

I

Inje University

Status

Completed

Conditions

Gallbladder Disease

Treatments

Procedure: 2- mini-instrument

Study type

Interventional

Funder types

Other

Identifiers

NCT01571479
2012-026

Details and patient eligibility

About

The aim of this study was to show that this technique is feasible, safe and easily reproducible and to evaluate the selection criteria for a three-port laparoscopic cholecystectomy using a 2-mm mini-port.

Full description

Since the first four-port laparoscopic cholecystectomy (LC) was reported in 1987, various surgical options for LC have been developed. Recently, single port LC (SPLC) has been increasingly performed to minimize tissue trauma, improve cosmesis and decrease postoperative pain for patients. Some surgeons suggest that the four- or three-port LC using mini-ports could be as safe, effective, economical and cosmetic as SPLC. For this reason, the investigators started M-LC for patients with benign gallbladder disease in April 2010.

Prospectively collected data from 133 patients who underwent LC for benign gallbladder disease between April 2010 and April 2011 were retrospectively reviewed.

The patient's selection for M-LC was determined by surgeon's judgment based on 'laparoscopic surgical view' after inserting the laparoscope in the operating room.

Enrollment

133 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all patients required laparoscopic cholecystectomy for benign gallbladder diseases.

Exclusion criteria

  • open cholecystectomy

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

133 participants in 2 patient groups

2-mm mini-instrument (M-LC)
No Intervention group
Description:
M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.
Treatment:
Procedure: 2- mini-instrument
conventional instrument(C-LC)
No Intervention group
Description:
C-LC is conventional three port laparoscopic cholecystectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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