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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Four port laparoscopic cholecystectomy surgery
Sponsored by
IRCCS Sacro Cuore Don Calabria di Negrar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring single port cholecystectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sacro Cuore - Don Calabria HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single port laparoscopic device

Four-port laparoscopic device

Arm Description

Outcomes

Primary Outcome Measures

Post-operative pain scores (visual analogue pain scale from 0-10)

Secondary Outcome Measures

Patient-assessed cosmesis on the Visual Analogue Scale

Full Information

First Posted
April 26, 2011
Last Updated
May 4, 2011
Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
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1. Study Identification

Unique Protocol Identification Number
NCT01348620
Brief Title
Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
single port cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single port laparoscopic device
Arm Type
Experimental
Arm Title
Four-port laparoscopic device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Other Intervention Name(s)
One-trocar cholecistectomy
Intervention Description
Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Intervention Type
Procedure
Intervention Name(s)
Four port laparoscopic cholecystectomy surgery
Other Intervention Name(s)
traditional Laparoscopic cholecistectomy
Intervention Description
Four port laparoscopic cholecystectomy surgery
Primary Outcome Measure Information:
Title
Post-operative pain scores (visual analogue pain scale from 0-10)
Time Frame
Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery
Secondary Outcome Measure Information:
Title
Patient-assessed cosmesis on the Visual Analogue Scale
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuliano Barugola, MD
Phone
00390456013111
Email
barugolagiuliano@hotmail.com
Facility Information:
Facility Name
Sacro Cuore - Don Calabria Hospital
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuliano Barugola, MD
Email
barugolagiuliano@hotmail.com
First Name & Middle Initial & Last Name & Degree
Giacomo Ruffo, MD
First Name & Middle Initial & Last Name & Degree
Giuliano Barugola, MD
First Name & Middle Initial & Last Name & Degree
Alberto Sartori, MD
First Name & Middle Initial & Last Name & Degree
Stefano crippa, MD
First Name & Middle Initial & Last Name & Degree
Stefano Partelli, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18982149
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.
Results Reference
background
PubMed Identifier
20066749
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. doi: 10.3748/wjg.v16.i2.270.
Results Reference
background
PubMed Identifier
18815836
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.
Results Reference
background
PubMed Identifier
18709515
Citation
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.
Results Reference
background
PubMed Identifier
19630589
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.
Results Reference
background
PubMed Identifier
26036221
Citation
Partelli S, Barugola G, Sartori A, Crippa S, Falconi M, Ruffo G. Single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy performed by a single surgeon: findings of a randomized trial. Surg Today. 2016 Mar;46(3):313-8. doi: 10.1007/s00595-015-1182-7. Epub 2015 Jun 3.
Results Reference
derived
PubMed Identifier
21910897
Citation
Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
Results Reference
derived

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

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