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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571479
Other study ID # 2012-026
Secondary ID
Status Completed
Phase N/A
First received March 31, 2012
Last updated April 3, 2012
Start date April 2010
Est. completion date March 2012

Study information

Verified date April 2012
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of University of Inje College of Medicine, Haeundae Paik Hopsital Busan

Sponsors (1)

Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with complications or open conversion to M-LC one year
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