NCT02401087

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

March 24, 2015

Last Update Submit

August 26, 2019

Conditions

Varicocele

Outcome Measures

Primary Outcomes (1)

  • discharge time

    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 Outcomes (3)

  • Difference in the onset of acute post-operative pain

    four days

  • Check the occurence of any side effects

    three months

  • Clinical evaluation of patients at 1 and 3 months after surgery (possibility of chronic pain)

    three months

Interventions

Anaesthesiological procedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Male
  • ASA I-II
  • No mental alteration

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, 21100, Italy

Location

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Stefania Turconi, MD

    University Hospital Varese

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

August 1, 2016

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

IT(1)