The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument
Primary Purpose
Gallbladder Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
2- mini-instrument
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Disease focused on measuring laparoscopic cholecystectomy, mini-instrument
Eligibility Criteria
Inclusion Criteria:
- all patients required laparoscopic cholecystectomy for benign gallbladder diseases.
Exclusion Criteria:
- open cholecystectomy
Sites / Locations
- University of Inje College of Medicine, Haeundae Paik Hopsital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
No Intervention
Arm Label
2-mm mini-instrument (M-LC)
conventional instrument(C-LC)
Arm Description
M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.
C-LC is conventional three port laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
Number of participants with complications or open conversion to M-LC
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01571479
Brief Title
The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument
Official Title
The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Disease
Keywords
laparoscopic cholecystectomy, mini-instrument
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-mm mini-instrument (M-LC)
Arm Type
No Intervention
Arm Description
M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.
Arm Title
conventional instrument(C-LC)
Arm Type
No Intervention
Arm Description
C-LC is conventional three port laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
2- mini-instrument
Other Intervention Name(s)
micro-instrument
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with complications or open conversion to M-LC
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients required laparoscopic cholecystectomy for benign gallbladder diseases.
Exclusion Criteria:
open cholecystectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kwan woo kim
Organizational Affiliation
University of Inje College of Medicine, Haeundae Paik Hopsital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Inje College of Medicine, Haeundae Paik Hopsital
City
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21227454
Citation
Aprea G, Coppola Bottazzi E, Guida F, Masone S, Persico G. Laparoendoscopic single site (LESS) versus classic video-laparoscopic cholecystectomy: a randomized prospective study. J Surg Res. 2011 Apr;166(2):e109-12. doi: 10.1016/j.jss.2010.11.885. Epub 2010 Dec 22.
Results Reference
result
PubMed Identifier
11928028
Citation
Bisgaard T, Klarskov B, Trap R, Kehlet H, Rosenberg J. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial. Surg Endosc. 2002 Mar;16(3):458-64. doi: 10.1007/s00464-001-9026-5. Epub 2001 Nov 16.
Results Reference
result
PubMed Identifier
21173293
Citation
Chow A, Purkayastha S, Aziz O, Pefanis D, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: a retrospective comparison with 4-port laparoscopic cholecystectomy. Arch Surg. 2010 Dec;145(12):1187-91. doi: 10.1001/archsurg.2010.267.
Results Reference
result
PubMed Identifier
20135180
Citation
Curcillo PG 2nd, Wu AS, Podolsky ER, Graybeal C, Katkhouda N, Saenz A, Dunham R, Fendley S, Neff M, Copper C, Bessler M, Gumbs AA, Norton M, Iannelli A, Mason R, Moazzez A, Cohen L, Mouhlas A, Poor A. Single-port-access (SPA) cholecystectomy: a multi-institutional report of the first 297 cases. Surg Endosc. 2010 Aug;24(8):1854-60. doi: 10.1007/s00464-009-0856-x. Epub 2010 Feb 5.
Results Reference
result
PubMed Identifier
20198490
Citation
Edwards C, Bradshaw A, Ahearne P, Dematos P, Humble T, Johnson R, Mauterer D, Soosaar P. Single-incision laparoscopic cholecystectomy is feasible: initial experience with 80 cases. Surg Endosc. 2010 Sep;24(9):2241-7. doi: 10.1007/s00464-010-0943-z. Epub 2010 Mar 3.
Results Reference
result
PubMed Identifier
20421017
Citation
Elsey JK, Feliciano DV. Initial experience with single-incision laparoscopic cholecystectomy. J Am Coll Surg. 2010 May;210(5):620-4, 624-6. doi: 10.1016/j.jamcollsurg.2009.12.030.
Results Reference
result
PubMed Identifier
16709356
Citation
Franklin ME Jr, Jaramillo EJ, Glass JL, Trevino JM, Berghoff KR. Needlescopic cholecystectomy: lessons learned in 10 years of experience. JSLS. 2006 Jan-Mar;10(1):43-6.
Results Reference
result
PubMed Identifier
9649038
Citation
Gagner M, Garcia-Ruiz A. Technical aspects of minimally invasive abdominal surgery performed with needlescopic instruments. Surg Laparosc Endosc. 1998 Jun;8(3):171-9.
Results Reference
result
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The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument
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