The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis

August 26, 2019 updated by: Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi
The aim of this observational study was to evaluate, based on the intraoperative anesthetic that is routinely carried out at the Department of Day Surgery, the difference in timing of the patient's discharge from the hospital (ie when the patient has autonomous demabulation and urination spontaneous) in patients undergoing correction of varicocele according Marmar.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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
    • VA
      • Varese, VA, Italy, 21100
        • Department of Day Surgery Ospedale di Circolo Varese

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

The patients will be identified as potentially were to be enrolled in the preoperative anesthetic visit.

Description

Inclusion Criteria:

  • Male
  • ASA I-II
  • No mental alteration

Exclusion Criteria:

  • Chronic pain
  • Allergies to local anaesthetics, acetaminophen,oppioids
  • ASA III - IV
  • Postoperative discharge to ICU
  • Epatic or renal failure
  • Mental status alteration
  • Coagulopathy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discharge time
Time Frame: one day
check the elapsed time between the induction of anesthesia and obtaining discharge criteria, urination and deambulation, from the Department of Day Surgery.
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in the onset of acute post-operative pain
Time Frame: four days
four days
Check the occurence of any side effects
Time Frame: three months
three months
Clinical evaluation of patients at 1 and 3 months after surgery (possibility of chronic pain)
Time Frame: three months
three months

Collaborators and Investigators

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

Sponsor

Ospedale di Circolo - Fondazione Macchi

Investigators

  • Principal Investigator: Stefania Turconi, MD, University Hospital Varese

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

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Var-001

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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