The Anaesthesiological Approach to Varicocele Correction... | NCT02401087

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

NCT02401087

Sponsor

Ospedale di Circolo - Fondazione Macchi

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Varicocele

Interventions

Anaesthesiological procedure

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2015Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 24, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Mar 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Luigi Ambrosoli, M.D., Ospedale di Circolo - Fondazione MacchiPrincipal Investigator

Lead Sponsor

Ospedale di Circolo - Fondazione MacchiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Anaesthesiological procedure	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefania Turconi, MD	University Hospital Varese	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Day Surgery Ospedale di Circolo Varese		Varese	VA	21100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D014646	Varicocele

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided