Valsalva Maneuver in Thyroidectomy

NCT ID: NCT05474261

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-04-10

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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GROUP A-NO Valsalva maneuver

No interventions assigned to this group

GROUP B- Valsalva maneuver

Valsalva maneuver

Intervention Type PROCEDURE

Valsalva maneuver: increase intrabdominal pressure

Interventions

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Valsalva maneuver

Valsalva maneuver: increase intrabdominal pressure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* thyroid diseases

Exclusion Criteria

* lymph node dissection
* minimally invasive approaches
* high anesthesiological risk
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Mario Pacilli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico Di Foggia

Foggia, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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UFoggia2

Identifier Type: -

Identifier Source: org_study_id

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