Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01348620
• Other study ID #: MNT-2011
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2011
• Last updated: May 4, 2011
• Start date: March 2011

Study information

• Verified date: May 2011
• Source: Sacro Cuore Don Calabria General Hospital
• Contact: Giuliano Barugola, MD
• Phone: 00390456013111
• Email: barugolagiuliano[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Description:

The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures.

Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies.

The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Biliary cholic

• Biliary dyskinesia

• Gallbladder polyps

• Other diagnosis at the discretion of the surgeon

Exclusion Criteria:

• History of Acute cholecystitis

• Jaundice

• Choledocolithiasis

• History of Pancreatitis

• Severe comorbidity

• BMI > 30

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)

Procedure:
• Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery

Locations

Country	Name	City	State
Italy	Sacro Cuore - Don Calabria Hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Sacro Cuore Don Calabria General Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Gumbs AA, Milone L, Sinha P, Bessler M. Totally transumbilical laparoscopic cholecystectomy. J Gastrointest Surg. 2009 Mar;13(3):533-4. doi: 10.1007/s11605-008-0614-8. — View Citation

Hirano Y, Watanabe T, Uchida T, Yoshida S, Tawaraya K, Kato H, Hosokawa O. Single-incision laparoscopic cholecystectomy: single institution experience and literature review. World J Gastroenterol. 2010 Jan 14;16(2):270-4. Review. — View Citation

Kuon Lee S, You YK, Park JH, Kim HJ, Lee KK, Kim DG. Single-port transumbilical laparoscopic cholecystectomy: a preliminary study in 37 patients with gallbladder disease. J Laparoendosc Adv Surg Tech A. 2009 Aug;19(4):495-9. doi: 10.1089/lap.2008.0424. — View Citation

Rao PP, Bhagwat SM, Rane A, Rao PP. The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB (Oxford). 2008;10(5):336-40. doi: 10.1080/13651820802276622. — View Citation

Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain scores (visual analogue pain scale from 0-10)		Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery	No
Secondary	Patient-assessed cosmesis on the Visual Analogue Scale		30 days after surgery	No