GoiterNCT03615456
Sutureless Versus Conventional Thyroidectomy
A study testing Conventional thyroidectomy and Harmonic scalpel thyroidectomy in people with Goiter, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Goiter
- What is being tested?
- Conventional thyroidectomy and Harmonic scalpel thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 12 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:
- Solitary thyroid nodule (STN)
- Multinodular goiter
- Controlled toxic goiter
- Inflammatory goiter (thyroiditis)
- Early-stage thyroid cancer.
Who cannot join
- Patients unfit for surgery
- patients unwilling to participate in the study
- Pregnant women
- Thyroid cancer with lymph node or distant metastasis.
- Patients with psychiatric disturbances.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial
This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel
- Conditions
- Goiter
- Being tested
- Conventional thyroidectomy, Harmonic scalpel thyroidectomy
- Medical subject headings
- Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional thyroidectomyProcedure or surgery
Thyroid vessels are ligated with sutures and divided
Harmonic scalpel thyroidectomyProcedure or surgery
Thyroid vessels are sealed using harmonic scalpel device
| Study group | Role | What they receive |
|---|---|---|
| Conventional thyroidectomy | Active comparator | Thyroidectomy with ligation and division of thyroid vessels Receives: Procedure: Conventional thyroidectomy |
| Harmonic scalpel thyroidectomy | Active comparator | Thyroidectomy with sealing of thyroid vessels using harmonic scalpel Receives: Procedure: Harmonic scalpel thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of postoperative drainage
The volume of fluid drained in the suction drain placed in the neck in milliliters
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Feb 2017
- Primary completion28 Feb 2018
- Study completion12 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoiterStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sabry Mahmoud, M.D., Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615456
- Sponsor's protocol ID
- mansoura62
- Status last verified
- Feb 2019
- First submitted
- 30 Jul 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03615456
- Acronym / sponsor ID
- mansoura62
- Conditions
- Goiter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 12 May 2018 (actual)
- First posted
- 3 Aug 2018 (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.
This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional thyroidectomy | Active comparator | Procedure: Conventional thyroidectomyThyroidectomy with ligation and division of thyroid vessels |
| Harmonic scalpel thyroidectomy | Active comparator | Procedure: Harmonic scalpel thyroidectomyThyroidectomy with sealing of thyroid vessels using harmonic scalpel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:
- Solitary thyroid nodule (STN)
- Multinodular goiter
- Controlled toxic goiter
- Inflammatory goiter (thyroiditis)
Key exclusion criteria (5 listed)
- Patients unfit for surgery
- patients unwilling to participate in the study
- Pregnant women
- Thyroid cancer with lymph node or distant metastasis.
- Patients with psychiatric disturbances.
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 |
|---|---|---|
| Conventional thyroidectomyThyroid vessels are ligated with sutures and divided | Procedure or surgery | Conventional thyroidectomy |
| Harmonic scalpel thyroidectomyThyroid vessels are sealed using harmonic scalpel device | Procedure or surgery | Harmonic scalpel thyroidectomy |
Primary outcome
Volume of postoperative drainage
Time frame: At 24 hours after surgery
The volume of fluid drained in the suction drain placed in the neck in milliliters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sabry Mahmoud, M.D. study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional thyroidectomy and Harmonic scalpel thyroidectomy in people with Goiter, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of postoperative drainage (time frame: At 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.