The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative BleedingNCT05474261
Valsalva Maneuver in Thyroidectomy
An observational study of The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding, run by University of Foggia at 1 site in Italy.
Trial summary
Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding
- What is being tested?
- Valsalva maneuver
- Type of treatment
- Surgery or procedure
- How many people
- 178 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 10 Apr 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients underwent total thyroidectomy
Who may be able to join
- thyroid diseases
Who cannot join
- lymph node dissection
- minimally invasive approaches
- high anesthesiological risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy
Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.
Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.
The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.
- Being tested
- Valsalva maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva maneuverProcedure or surgery
Valsalva maneuver: increase intrabdominal pressure
| Study group | Role | What they receive |
|---|---|---|
| GROUP A-NO Valsalva maneuver | Not described | |
| GROUP B- Valsalva maneuver | Not described Receives: Procedure: Valsalva maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of cervical drainage after total thyroidectomy
Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)
Measured: 24 hours
Number of reinterventions
Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2019
- Primary completion1 Feb 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative BleedingStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pacilli, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474261
- Sponsor's protocol ID
- UFoggia2
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy
- ClinicalTrials.gov ID
- NCT05474261
- Acronym / sponsor ID
- UFoggia2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- 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.
Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.
Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.
The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A-NO Valsalva maneuver | – | – |
| GROUP B- Valsalva maneuver | – | Procedure: Valsalva maneuver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients underwent total thyroidectomy
Key inclusion criteria (1 listed)
- thyroid diseases
Key exclusion criteria (3 listed)
- lymph node dissection
- minimally invasive approaches
- high anesthesiological risk
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 |
|---|---|---|
| Valsalva maneuverValsalva maneuver: increase intrabdominal pressure | Procedure or surgery | GROUP B- Valsalva maneuver |
Primary outcome
Volume of cervical drainage after total thyroidectomy
Time frame: 24 hours
Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)
Number of reinterventions
Time frame: 24 hours
Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.
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 29 Jul 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding, run by University of Foggia 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 1 inclusion and 3 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 29 Jul 2022. 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?
Volume of cervical drainage after total thyroidectomy (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 29 Jul 2022.