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Not yet recruiting NCT06765174

Randomized Controlled Trial Comparing Drains Usage vs Without Drains After Thyroid Surgery

No phase Interventional Thyroid Surgery Drains Post Thyroidectomy Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suction Drain placement (Example: Q-vac).
Who it may be relevant to
Registry conditions: Thyroid Surgery, Drains, Post Thyroidectomy Complications. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Drain vs no Drain After Thyroid Surgeries: a Prospective Randomized Clinical Trial.

Overview

The aim of this study is to compare patients who used drain to patients who did not use drain post-thyroidectomy regarding the short-term outcomes .

Interventions

  • Device Suction Drain placement (Example: Q-vac)
    After thyroid surgery we pust drain at bed of surgery to monitor post operative bleeding.

Primary outcome measures

  • Rate of hematoma post-operative . [Time frame: 24 hours]
Secondary outcome measures (5)
  • Rate of infection [Time frame: 7 days]
  • Rate of re intervention [Time frame: 7 days]
  • Post-operative pain by visual analogue scale [Time frame: 3 days]
  • Post-operative hospital stay in days [Time frame: 7 days]
  • Patient satisfaction by likert scale [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • (1) Male or female patients undergoing thyroidectomy (2) Patients with ages: from 18 to 60 years old. (3) Patients with normal thyroid function tests (4) Patients who are fit for general-anesthesia.

Exclusion criteria

  • (1) Patients with bleeding diathesis and those on anticoagulants. (2) Patients with thyrotoxicosis (uncontrolled) (3) Patients those requiring neck L.N dissection. (4) Patients with previous neck surgeries. (5) Patients with severe comorbid conditions with high risk for general anesthesia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Materazzi G, Ambrosini CE, Fregoli L, De Napoli L, Frustaci G, Matteucci V, Papini P, Bakkar S, Miccoli P. Prevention and management of bleeding in thyroid surgery. Gland Surg. 2017 Oct;6(5):510-515. doi: 10.21037/gs.2017.06.14. PMID 29142842
  • George NM, Chitrambalam TG, Christopher PJ, Marlecha M, Selvamuthukumaran S. To drain or not to drain following thyroidectomy.: A prospective, randomized study. Saudi Med J. 2023 May;44(5):518-521. doi: 10.15537/smj.2023.44.5.20220031. PMID 37182919
  • Liu J, Sun W, Dong W, Wang Z, Zhang P, Zhang T, Zhang H. Risk factors for post-thyroidectomy haemorrhage: a meta-analysis. Eur J Endocrinol. 2017 May;176(5):591-602. doi: 10.1530/EJE-16-0757. Epub 2017 Feb 8. PMID 28179452
  • de Carvalho AY, Gomes CC, Chulam TC, Vartanian JG, Carvalho GB, Lira RB, Kohler HF, Kowalski LP. Risk Factors and Outcomes of Postoperative Neck Hematomas: An Analysis of 5,900 Thyroidectomies Performed at a Cancer Center. Int Arch Otorhinolaryngol. 2021 Jul;25(3):e421-e427. doi: 10.1055/s-0040-1714129. Epub 2020 Sep 30. PMID 34377179
  • Musa AA, Agboola OJ, Banjo AA, Oyegunle O. The use of drains in thyroid surgery. Niger Postgrad Med J. 2010 Mar;17(1):15-8. PMID 20348976
  • Portinari M, Carcoforo P. The application of drains in thyroid surgery. Gland Surg. 2017 Oct;6(5):563-573. doi: 10.21037/gs.2017.07.04. PMID 29142849
  • Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Di PMID 26462967

Identifiers

NCT: NCT06765174 · Drains Post thyroidectomy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗