NCT06765174

Brief Summary

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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

December 24, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 9, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 24, 2024

Last Update Submit

January 3, 2025

Conditions

Thyroid SurgeryDrainsPost Thyroidectomy Complications

Outcome Measures

Primary Outcomes (1)

  • Rate of hematoma post-operative .

    Rate of post operative hematoma formation and effect of drain in preventing it

    24 hours

Secondary Outcomes (5)

  • Rate of infection

    7 days

  • Rate of re intervention

    7 days

  • Post-operative pain by visual analogue scale

    3 days

  • Post-operative hospital stay in days

    7 days

  • Patient satisfaction by likert scale

    7 days

Study Arms (2)

Group drain (A)

ACTIVE COMPARATOR

Drain placement post thyroid surgery

Device: Suction Drain placement (Example: Q-vac)

Group no drain (B)

NO INTERVENTION

No drain placement post thyroid surgery

Interventions

Suction Drain placement (Example: Q-vac)DEVICE

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

Group drain (A)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 29142842BACKGROUND

  • 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: 37182919BACKGROUND

  • 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: 28179452BACKGROUND

  • 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: 34377179BACKGROUND

  • 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: 20348976BACKGROUND

  • 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: 29142849BACKGROUND

  • 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.

    PMID: 26462967BACKGROUND

Study Officials

  • Mostafa Abdel ghafour

    Affiliated

    STUDY DIRECTOR

Central Study Contacts

Helmy H.K Khaled

CONTACT

+201030656512helmykhaled2017@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Helmy khaled helmy

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 9, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

January 9, 2025

Record last verified: 2024-12