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

Purpose

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	Intervention
Gallbladder Disease	Procedure: 2- mini-instrument


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Gallbladder Diseases

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:

Number of participants with complications or open conversion to M-LC [ Time Frame: one year ] [ Designated as safety issue: Yes ]


Enrollment:	133
Study Start Date:	April 2010
Study Completion Date:	March 2012
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

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.

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. Epub 2001 Nov 16.

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.

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.

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.

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.

Franklin ME Jr, Jaramillo EJ, Glass JL, Treviño JM, Berghoff KR. Needlescopic cholecystectomy: lessons learned in 10 years of experience. JSLS. 2006 Jan-Mar;10(1):43-6.

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.


Responsible Party:	Kwan Woo Kim, Haeundae paik hospital, Inje University
ClinicalTrials.gov Identifier:	NCT01571479 History of Changes
Other Study ID Numbers:	2012-026
Study First Received:	March 31, 2012
Last Updated:	April 3, 2012
Health Authority:	Korea: Institutional Review Board

Keywords provided by Inje University:


laparoscopic cholecystectomy mini-instrument

Additional relevant MeSH terms:


Gallbladder Diseases Biliary Tract Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on February 25, 2015