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OpenTrials
Completed

NCT Number: NCT05474261

Valsalva Maneuver in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Di Foggia

Foggia, 71122, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • thyroid diseases

Exclusion criteria

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

Treatment and study plan

valsalva maneuver

Procedure

Valsalva maneuver: increase intrabdominal pressure

Primary outcomes

  1. 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)

  2. Number of reinterventions

    Time frame: 24 hours

    Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.