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Valsalva Maneuver in Thyroidectomy

NCT05474261 — Completed, 178 participants, University of Foggia

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Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy

RegistryNCT05474261
StatusCompleted
Study typeObservational
Enrollment178 (Actual)
SponsorUniversity of Foggia (Other)
ConditionsThe Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding
InterventionsValsalva maneuver (Procedure)
Datesstart 2019-01-01, primary completion 2022-02-01, completion 2022-04-10, first posted 2022-07-26, last updated 2022-07-29
Locations1 site in Italy

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All trials for The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding All trials of Valsalva maneuver

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
GROUP A-NO Valsalva maneuver
GROUP B- Valsalva maneuverProcedure: Valsalva maneuver
  • Valsalva maneuver (Procedure): Valsalva maneuver: increase intrabdominal pressure

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* thyroid diseases

Exclusion Criteria:

* lymph node dissection
* minimally invasive approaches
* high anesthesiological risk

+Locations (1)

FacilityCityCountryStatus
Policlinico Di FoggiaFoggiaItaly

+Study documents

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