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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Sacro Cuore Don Calabria General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sacro Cuore Don Calabria General Hospital
ClinicalTrials.gov Identifier:
NCT01348620
First received: April 26, 2011
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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 Intervention
Postoperative Pain
Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Procedure: Four port laparoscopic cholecystectomy surgery

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

Further study details as provided by Sacro Cuore Don Calabria General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-assessed cosmesis on the Visual Analogue Scale [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: March 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348620

Contacts
Contact: Giuliano Barugola, MD 00390456013111 barugolagiuliano@hotmail.com

Locations
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
Sacro Cuore Don Calabria General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Perantoni Laura, Sacro Cuore Don Calabria General Hospital
ClinicalTrials.gov Identifier: NCT01348620     History of Changes
Other Study ID Numbers: MNT-2011
Study First Received: April 26, 2011
Last Updated: May 4, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Sacro Cuore Don Calabria General Hospital:
single port cholecystectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014