Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01348620
Recruitment Status : Unknown
Verified May 2011 by IRCCS Sacro Cuore Don Calabria di Negrar.
Recruitment status was:  Recruiting
First Posted : May 5, 2011
Last Update Posted : May 5, 2011
Sponsor:
Information provided by:
IRCCS Sacro Cuore Don Calabria di Negrar

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa) Procedure: Four port laparoscopic cholecystectomy surgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2011
Estimated Primary Completion Date : January 2012

Arm Intervention/treatment
Experimental: Single port laparoscopic device 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)
Other Name: One-trocar cholecistectomy

Active Comparator: Four-port laparoscopic device Procedure: Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery
Other Name: traditional Laparoscopic cholecistectomy




Primary Outcome Measures :
  1. 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 Measures :
  1. Patient-assessed cosmesis on the Visual Analogue Scale [ Time Frame: 30 days after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348620


Contacts
Layout table for location contacts
Contact: Giuliano Barugola, MD 00390456013111 barugolagiuliano@hotmail.com

Locations
Layout table for location information
Italy
Sacro Cuore - Don Calabria Hospital Recruiting
Negrar, Verona, Italy, 37024
Contact: Giuliano Barugola, MD       barugolagiuliano@hotmail.com   
Principal Investigator: Giacomo Ruffo, MD         
Sub-Investigator: Giuliano Barugola, MD         
Sub-Investigator: Alberto Sartori, MD         
Sub-Investigator: Stefano crippa, MD         
Sub-Investigator: Stefano Partelli, MD         
Sponsors and Collaborators
IRCCS Sacro Cuore Don Calabria di Negrar
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr Perantoni Laura, Sacro Cuore Don Calabria General Hospital
ClinicalTrials.gov Identifier: NCT01348620    
Other Study ID Numbers: MNT-2011
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011
Keywords provided by IRCCS Sacro Cuore Don Calabria di Negrar:
single port cholecystectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations