VaricoceleNCT02401087
The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis
An observational study of Varicocele, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Anaesthesiological procedure
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be identified as potentially were to be enrolled in the preoperative anesthetic visit.
Who may be able to join
- Male
- ASA I-II
- No mental alteration
Who cannot join
- Chronic pain
- Allergies to local anaesthetics, acetaminophen,oppioids
- ASA III - IV
- Postoperative discharge to ICU
- Epatic or renal failure
- Mental status alteration
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Day Surgery Ospedale di Circolo Varese
Varese, VA, 21100
About this study
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.
- Conditions
- Varicocele
- Being tested
- Anaesthesiological procedure
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaesthesiological procedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
discharge time
check the elapsed time between the induction of anesthesia and obtaining discharge criteria, urination and deambulation, from the Department of Day Surgery.
Measured: one day
Secondary outcomes (3)
Difference in the onset of acute post-operative pain
Measured: four days
Check the occurence of any side effects
Measured: three months
Clinical evaluation of patients at 1 and 3 months after surgery (possibility of chronic pain)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi
- Investigators
- Stefania Turconi, MD, Principal investigator, University Hospital Varese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401087
- Sponsor's protocol ID
- Var-001
- Status last verified
- Aug 2019
- First submitted
- 24 Mar 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis
- ClinicalTrials.gov ID
- NCT02401087
- Acronym / sponsor ID
- Var-001
- Conditions
- Varicocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be identified as potentially were to be enrolled in the preoperative anesthetic visit.
Key inclusion criteria (3 listed)
- Male
- ASA I-II
- No mental alteration
Key exclusion criteria (7 listed)
- Chronic pain
- Allergies to local anaesthetics, acetaminophen,oppioids
- ASA III - IV
- Postoperative discharge to ICU
- Epatic or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anaesthesiological procedure | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
Difference in the onset of acute post-operative pain
Time frame: four days
Check the occurence of any side effects
Time frame: three months
Clinical evaluation of patients at 1 and 3 months after surgery (possibility of chronic pain)
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Turconi, MD principal investigator
University Hospital Varese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discharge time (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.