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

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ClinicalTrials.gov Identifier: NCT01571479
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Kwan Woo Kim, Inje University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gallbladder Disease Procedure: 2- mini-instrument Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : March 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with complications or open conversion to M-LC [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients required laparoscopic cholecystectomy for benign gallbladder diseases.

Exclusion Criteria:

  • open cholecystectomy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571479


Locations
Korea, Republic of
University of Inje College of Medicine, Haeundae Paik Hopsital
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: kwan woo kim University of Inje College of Medicine, Haeundae Paik Hopsital
More Information
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Publications of Results:

Responsible Party: Kwan Woo Kim, Haeundae paik hospital, Inje University
ClinicalTrials.gov Identifier: NCT01571479     History of Changes
Other Study ID Numbers: 2012-026
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Kwan Woo Kim, Inje University:
laparoscopic cholecystectomy
mini-instrument

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases