An interventional study of 2- mini-instrument in Gallbladder Disease, sponsored by Inje University. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2012-04-05.
Sponsored by Inje University · Not applicable, Interventional, and Treatment
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.
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.
91 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 133 is above the median of 84 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Inje University is the lead sponsor of 90 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.
Procedure: 2- mini-instrument
C-LC is conventional three port laparoscopic cholecystectomy
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.
Also known as: micro-instrument
Number of participants with complications or open conversion to M-LC
Time frame: one year
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Inje University