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

May 4, 2011 updated by: IRCCS Sacro Cuore Don Calabria di Negrar
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • Sacro Cuore - Don Calabria Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • One-trocar cholecistectomy
Active Comparator: Four-port laparoscopic device
Procedure: Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery
Other Names:
  • traditional Laparoscopic cholecistectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-assessed cosmesis on the Visual Analogue Scale
Time Frame: 30 days after surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

May 5, 2011

Last Update Submitted That Met QC Criteria

May 4, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNT-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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