Valsalva Maneuver in Thyroidectomy | NCT05474261

Studies
Valsalva Maneuver in Thyroidectomy

NCT05474261

Sponsor

University of Foggia

Status

Completed

Last Update Posted

Jul 29, 2022Actual

Enrollment

178Actual

Phase

Not provided

Conditions

The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding

Interventions

Valsalva maneuver

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

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

Jan 1, 2019Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Apr 10, 2022Actual

First Submitted Date

Jul 19, 2022

First Submission Date that Met QC Criteria

Jul 22, 2022

First Posted Date

Jul 26, 2022Actual

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

Jul 26, 2022

Last Update Posted Date

Jul 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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

178Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP A-NO Valsalva maneuver
GROUP B- Valsalva maneuver			Procedure: Valsalva maneuver

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valsalva maneuver	Procedure	Valsalva maneuver: increase intrabdominal pressure	GROUP B- Valsalva maneuver

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volume of cervical drainage after total thyroidectomy	Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)	24 hours
Number of reinterventions	Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

thyroid diseases

Exclusion Criteria:

lymph node dissection
minimally invasive approaches
high anesthesiological risk

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients underwent total thyroidectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Di Foggia		Foggia		71122	Italy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 15, 2022	Jul 19, 2022	Prot_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D014636	Valsalva Maneuver

Ancestor Terms

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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