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

NCT ID: NCT06765174

Last Updated: 2025-01-09

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-01-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Thyroid Surgery Drains Post Thyroidectomy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group drain (A)

Drain placement post thyroid surgery

Group Type ACTIVE_COMPARATOR

Suction Drain placement (Example: Q-vac)

Intervention Type DEVICE

After thyroid surgery we pust drain at bed of surgery to monitor post operative bleeding.

Group no drain (B)

No drain placement post thyroid surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Suction Drain placement (Example: Q-vac)

After thyroid surgery we pust drain at bed of surgery to monitor post operative bleeding.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Helmy Khaled Helmy

Helmy khaled helmy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa Abdel ghafour

Role: STUDY_DIRECTOR

Affiliated

Central Contacts

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Helmy H.K Khaled

Role: CONTACT

+201030656512

References

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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.

Reference Type BACKGROUND
PMID: 29142842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37182919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28179452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34377179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20348976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29142849 (View on PubMed)

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 Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

Reference Type BACKGROUND
PMID: 26462967 (View on PubMed)

Other Identifiers

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Drains Post thyroidectomy

Identifier Type: -

Identifier Source: org_study_id

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