Currently, both the American Thyroid Association and the European Thyroid Association recommend the use of Lugol Solution (LS) in the preparation of patients undergoing thyroidectomy for Graves' disease (GD), but their recommendations are based on a low level of evidence. This means that its use is not generalized among the different endocrine surgery units.
Methods:
Study population: 270 patients (135 patients in each arms) undergoing total thyroidectomy (TT) due to GD in Spanish hospitals, which perform a minimum of 100 thyroidectomies a year, at least 10 of them for GD.
Variables:
Preoperative variables
Intraoperative variables
Postoperative variables
Condition or disease | Intervention/treatment | Phase |
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Hyperthyroidism, Autoimmune | Drug: Lugols Strong Iodine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 270 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Trial, Blinded for the Researcher and Multicenter, to Evaluate the Efficacy and Safety of Preoperative Preparation With Lugol Solution in Euthyroid Patients With Graves-Basedow Disease. |
Actual Study Start Date : | November 25, 2019 |
Estimated Primary Completion Date : | January 31, 2021 |
Estimated Study Completion Date : | September 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Preoperative Lugol Solution preparation
Patients will receive Lugol Solution preparation for 10 days before thyroidectomy
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Drug: Lugols Strong Iodine
5 L.I. drops / 8 hours for 10 days before surgery
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No Intervention: No preparation
Patients will not receive preparation before thyroidectomy
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet all of the following criteria will be eligible:
Exclusion Criteria:
The participant can not participate in the study if he / she presents any of the following circumstances:
Contact: Jesús María Villar del Moral | +34958020349 | jesusm.villar.sspa@juntadeandalucia.es | |
Contact: José Luis Muñoz de Nova | +34915202448 | jmunoz@salud.madrid.org |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 30, 2019 | ||||||||
First Posted Date ICMJE | June 10, 2019 | ||||||||
Last Update Posted Date | January 22, 2021 | ||||||||
Actual Study Start Date ICMJE | November 25, 2019 | ||||||||
Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Postoperative complications [ Time Frame: 30 days after surgery ] To analyze whether, in euthyroid patients undergoing TT due to GD, preoperative non-preparation with LS increases the appearance of postoperative complications compared to the use of LS preparation. The main variable will be the rate of postoperative complication: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Preoperative Preparation With Lugol Solution in Patients With Graves-Basedow Disease. | ||||||||
Official Title ICMJE | Randomized Clinical Trial, Blinded for the Researcher and Multicenter, to Evaluate the Efficacy and Safety of Preoperative Preparation With Lugol Solution in Euthyroid Patients With Graves-Basedow Disease. | ||||||||
Brief Summary |
Currently, both the American Thyroid Association and the European Thyroid Association recommend the use of Lugol Solution (LS) in the preparation of patients undergoing thyroidectomy for Graves' disease (GD), but their recommendations are based on a low level of evidence. This means that its use is not generalized among the different endocrine surgery units. Methods: Study population: 270 patients (135 patients in each arms) undergoing total thyroidectomy (TT) due to GD in Spanish hospitals, which perform a minimum of 100 thyroidectomies a year, at least 10 of them for GD. Variables: Preoperative variables
Intraoperative variables
Postoperative variables
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hyperthyroidism, Autoimmune | ||||||||
Intervention ICMJE | Drug: Lugols Strong Iodine
5 L.I. drops / 8 hours for 10 days before surgery
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
270 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 30, 2021 | ||||||||
Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Patients who meet all of the following criteria will be eligible:
Exclusion Criteria: The participant can not participate in the study if he / she presents any of the following circumstances:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Spain | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03980132 | ||||||||
Other Study ID Numbers ICMJE | LIGRADIS | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jesús María Villar del Moral, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | ||||||||
Study Sponsor ICMJE | Jesús María Villar del Moral | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |