ClinicalTrials.gg
CompletedNCT03615456Updated Feb 5, 2019

Sutureless Versus Conventional Thyroidectomy

An interventional study of Conventional thyroidectomy and Harmonic scalpel thyroidectomy in Goiter, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Feb 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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 harmonic scalpel

02

Conditions studied

  • Goiter

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03

In context

Goiter

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's enrollment of 42 is below the median of 100 across 42 interventional studies indexed under Goiter.

Browse Goiter studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • Patients unfit for surgery
  • patients unwilling to participate in the study
  • Pregnant women
  • Thyroid cancer with lymph node or distant .
  • Patients with psychiatric disturbances.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Conventional thyroidectomy

    Thyroidectomy with ligation and division of thyroid vessels

    Procedure: Conventional thyroidectomy

  • Active comparator
    Harmonic scalpel thyroidectomy

    Thyroidectomy with sealing of thyroid vessels using harmonic scalpel

    Procedure: Harmonic scalpel thyroidectomy

Interventions

  • ProcedureConventional thyroidectomy

    Thyroid vessels are ligated with sutures and divided

  • ProcedureHarmonic scalpel thyroidectomy

    Thyroid vessels are sealed using harmonic scalpel device

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What researchers measure

Primary outcomes

  1. Volume of postoperative drainage

    The volume of fluid drained in the suction drain placed in the neck in milliliters

    Time frame: At 24 hours after surgery

07

Study locations

1 site
  • Mansoura university hospital
    Mansourah, Dakahlia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in Feb 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2018
First posted
Aug 3, 2018
StartActual
Feb 1, 2017
Primary completionActual
Feb 28, 2018
CompletionActual
May 12, 2018
Last update
Feb 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03615456
Responsible party
Sameh Emile (Assistant professor of surgery, Mansoura University) — Principal investigator
First posted
Aug 3, 2018
Start date
Feb 1, 2017
Primary completion
Feb 28, 2018
Completion
May 12, 2018
Last update
Feb 5, 2019

Study contacts

Sabry Mahmoud, M.D.
study chair · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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