NCT01571479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

March 31, 2012

Last Update Submit

April 3, 2012

Conditions

Gallbladder Disease

Keywords

laparoscopic cholecystectomymini-instrument

Outcome Measures

Primary Outcomes (1)

  • Number of participants with complications or open conversion to M-LC

    one year

Study Arms (2)

2-mm mini-instrument (M-LC)

NO INTERVENTION

M-LC is three-port laparoscopic cholecystectomy using a 2-mm mini-instrument.

Procedure: 2- mini-instrument

conventional instrument(C-LC)

NO INTERVENTION

C-LC is conventional three port laparoscopic cholecystectomy

Interventions

2- mini-instrumentPROCEDURE

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
2-mm mini-instrument (M-LC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients required laparoscopic cholecystectomy for benign gallbladder diseases.

You may not qualify if:

  • open cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Inje College of Medicine, Haeundae Paik Hopsital

Busan, 612-030, South Korea

Location

Related Publications (8)

  • 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.

    PMID: 21227454RESULT

  • 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.

    PMID: 11928028RESULT

  • 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.

    PMID: 21173293RESULT

  • 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.

    PMID: 20135180RESULT

  • 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.

    PMID: 20198490RESULT

  • 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.

    PMID: 20421017RESULT

  • 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.

    PMID: 16709356RESULT

  • 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.

    PMID: 9649038RESULT

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • kwan woo kim

    University of Inje College of Medicine, Haeundae Paik Hopsital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Haeundae paik hospital

Study Record Dates

First Submitted

March 31, 2012

First Posted

April 5, 2012

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

March 1, 2012

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

KR(1)