The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument|
- Number of participants with complications or open conversion to M-LC [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
No Intervention: 2-mm mini-instrument (M-LC)
M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.
Procedure: 2- mini-instrument
The patient was positioned in the supine position with the head and right side up.
Under general anesthesia, pneumoperitoneum (12 mmHg) was established after an 11-mm port was placed through 11-mm transumbilical incision by the open method.
A 10-mm 0-degree laparoscope was inserted through this umbilical port. A 5-mm trocar was then placed in the epigastric area, and the surgeon determined through 'laparoscopic surgical view' whether the 2-mm mini-instrument could be used as the right subcostal port . If the 2-mm mini-instrument could be used as the right subcostal port, a 2-mm trocar was inserted . If not, a 5-mm trocar was inserted for the right subcostal port. Therefore, this point is the unique difference between the two groups.
Other Name: micro-instrument
No Intervention: conventional instrument(C-LC)
C-LC is conventional three port laparoscopic cholecystectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571479
|Korea, Republic of|
|University of Inje College of Medicine, Haeundae Paik Hopsital|
|Busan, Korea, Republic of, 612-030|
|Principal Investigator:||kwan woo kim||University of Inje College of Medicine, Haeundae Paik Hopsital|