Thyroid SurgeryNCT06765174
Randomized Controlled Trial Comparing Drains Usage vs Without Drains After Thyroid Surgery
A study testing Suction Drain placement (Example: Q-vac) in people with Thyroid Surgery and Drains, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Surgery, Drains, Post Thyroidectomy Complications
- What is being tested?
- Suction Drain placement (Example: Q-vac)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Drain vs no Drain After Thyroid Surgeries: a Prospective Randomized Clinical Trial.
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 .
- Conditions
- Thyroid Surgery, Drains, Post Thyroidectomy Complications
- Being tested
- Suction Drain placement (Example: Q-vac)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction Drain placement (Example: Q-vac)Device
After thyroid surgery we pust drain at bed of surgery to monitor post operative bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Group drain (A) | Active comparator | Drain placement post thyroid surgery Receives: Device: Suction Drain placement (Example: Q-vac) |
| Group no drain (B) | No intervention | No drain placement post thyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hematoma post-operative .
Rate of post operative hematoma formation and effect of drain in preventing it
Measured: 24 hours
Secondary outcomes (5)
Rate of infection
Compare Rate of surgical site infection between two groups
Measured: 7 days
Rate of re intervention
Measured: 7 days
Post-operative pain by visual analogue scale
Measured: 3 days
Post-operative hospital stay in days
Length of hospital stay: described as the length of a single hospitalization, which is determined by subtracting the day of admission from the day of discharge. Data are collected from patients underwent thyroid surgery using a pretested, structured interviewer-administered questionnaire, medical record review,
Measured: 7 days
Patient satisfaction by likert scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helmy Khaled Helmy, Assiut University
- Investigators
- Mostafa Abdel ghafour, Study director, Affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765174
- Sponsor's protocol ID
- Drains Post thyroidectomy
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 29142842George 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.
PubMed 37182919Liu 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.
PubMed 28179452de 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.
PubMed 34377179Musa AA, Agboola OJ, Banjo AA, Oyegunle O. The use of drains in thyroid surgery. Niger Postgrad Med J. 2010 Mar;17(1):15-8.
PubMed 20348976Portinari 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.
PubMed 29142849Haugen 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.
PubMed 26462967
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drain vs no Drain After Thyroid Surgeries: a Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06765174
- Acronym / sponsor ID
- Drains Post thyroidectomy
- Conditions
- Thyroid Surgery, Drains, Post Thyroidectomy Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group drain (A) | Active comparator | Device: Suction Drain placement (Example: Q-vac)Drain placement post thyroid surgery |
| Group no drain (B) | No intervention | –No drain placement post thyroid surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction Drain placement (Example: Q-vac)After thyroid surgery we pust drain at bed of surgery to monitor post operative bleeding. | Device | Group drain (A) |
Primary outcome
Rate of hematoma post-operative .
Time frame: 24 hours
Rate of post operative hematoma formation and effect of drain in preventing it
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Results publication: PubMed 29142842Materazzi 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.
- Results publication: PubMed 37182919George 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.
- Results publication: PubMed 28179452Liu 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.
- Results publication: PubMed 34377179de 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.
- Results publication: PubMed 20348976Musa AA, Agboola OJ, Banjo AA, Oyegunle O. The use of drains in thyroid surgery. Niger Postgrad Med J. 2010 Mar;17(1):15-8.
- Results publication: PubMed 29142849Portinari 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.
- Results publication: PubMed 26462967Haugen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Abdel ghafour study director
Affiliated
Questions about this trial
What is this clinical trial studying?
A study testing Suction Drain placement (Example: Q-vac) in people with Thyroid Surgery and Drains, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helmy H.K Khaled (+201030656512, helmykhaled2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hematoma post-operative . (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765174, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.