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

Not Applicable

Completed

• Conditions: Gallbladder Disease
• Interventions: Procedure: 2- mini-instrument

• Registration Number: NCT01571479
• Lead Sponsor: Inje University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-04
• Study Completion: 2012-03
• Study First Submitted: 2012-03-31
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-03
• Last Update Submitted: 2012-04-03
• Study First Posted: 2012-04-05
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• all patients required laparoscopic cholecystectomy for benign gallbladder diseases.

Exclusion Criteria

• open cholecystectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-mm mini-instrument (M-LC)	2- mini-instrument	M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.

Primary Outcome Measures

Name	Time	Method
Number of participants with complications or open conversion to M-LC	one year

Trial Locations

Locations (1)

University of Inje College of Medicine, Haeundae Paik Hopsital; 🇰🇷 Busan, Korea, Republic of