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

Gallbladder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571479
• Other study ID #: 2012-026
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients required laparoscopic cholecystectomy for benign gallbladder diseases.

Exclusion Criteria:

• open cholecystectomy

Related Conditions & MeSH terms

• Gallbladder Disease
• Gallbladder Diseases

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)

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 201 — View 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. Epub 2001 Nov 16. — View 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. — View 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-inst — View 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 2 — View 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. — View Citation

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. — View 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. — View Citation

Outcome

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