Clinical and Surgical Outcomes of Total Thyroidectomy in Basedow's Disease: the Effect of Lugol Solution

NCT05784792 | Enrolling By Invitation

• 1 other identifier: UPd39962
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative preparation of patient with Basedow's disease is crucial to avoid severe thyrotoxicosis resulting from leakage of thyroid hormone into the circulation at the time of surgery. Moreover, hyperthyroidism-related hypervascularization and tissue fragility caused by Basedow's disease thyroiditis may cause intraoperative bleeding that can reduce the visualization and preservation of parathyroid glands and laryngeal nerves with subsequent higher risk of related morbidity including neck hematoma, hypoparathyroidism and vocal cords paresis. Although some endocrine surgeons administer before surgery Lugol solution to decrease thyroid gland vascularity in Basedow's disease, there is still not an agreement on its effectiveness. The aims of the present trial are to evaluate the impact of pre-operative short-term Lugol solution treatment (7 days) on surgical outcomes through modification of thyroid vascularity and surgical related morbidity, in patients with Basedow's disease.

Conditions

Basedow Disease

Keywords

Lugol Solution; Total Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• Intra and post-operative blood loss (mL).

  Blood loss volume (mL) as the amount of blood in the suction bottle and that absorbed by gauzes used during surgery was measured (volume calculated from the difference between dry gauzes weight and soaked gauzes weight). Evaluation of differences (if any) in this outcome in the two groups of the study (Lugol assumption/no Lugol assumption).

  Intra and post-operative bleeding (1st and 2nd day after surgery)

Secondary Outcomes (3)

• Post-operative laryngeal nerves palsy.

  Laryngeal ultrasound on 1st and 2nd day and indirect laryngoscopy in case of dysphonia

• Intra and post-operative thyrotoxicosis.

  During surgery and on 1st and 2nd day after surgery

• Post-operative hypocalcemia (hypoparathyroidism, hungry bone syndrome).

  Blood sample on 1st and 2nd day after surgery.

Other Outcomes (9)

• Change of ultrasound thyroid vascularization: blood flow velocity (v) variation (mm/sec).

  Thyroid US doppler data: 7 days before surgery and the day before surgery (after 1 week).

• Change of ultrasound thyroid vascularization: resistance index (RI) variation.

  Thyroid US doppler data: 7 days before surgery and the day before surgery (after 1 week).

• Change of ultrasound thyroid vascularization: pulsatility index (PI) variation

  Thyroid US doppler data: 7 days before surgery and the day before surgery (after 1 week).

Study Arms (2)

Lugol -

NO INTERVENTION

No pre-operative Lugol Solution preparation

Lugol +

ACTIVE COMPARATOR

Pre-operative Lugol preparation (10 drops per day orally three times a day for 7 days for an amount of 10,5 ml of Lugol solution that contains 1,68 gr of Iodine).

Other: Lugol -

Interventions

Lugol - OTHER

Patients that undergo total thyroidectomy without Lugol solution pretreatment

Lugol +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Basedow disease candidate to total thyroidectomy
• age\>18 years

You may not qualify if:

• age\<18 years;
• presence of solitary toxic nodule
• fine-needle aspiration biopsy result indicating cancer or suspicious cytology
• anticoagulant usage or coagulation disorders
• a previous thyroid operation
• pregnancy

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Università di Padova, Endocrine Surgery Unit

Padua, PD, 35121, Italy

Location

Related Publications (10)

• Hope N, Kelly A. Pre-Operative Lugol's Iodine Treatment in the Management of Patients Undergoing Thyroidectomy for Graves' Disease: A Review of the Literature. Eur Thyroid J. 2017 Feb;6(1):20-25. doi: 10.1159/000450976. Epub 2016 Nov 22.

  PMID: 28611944 RESULT

• Erbil Y, Ozluk Y, Giris M, Salmaslioglu A, Issever H, Barbaros U, Kapran Y, Ozarmagan S, Tezelman S. Effect of lugol solution on thyroid gland blood flow and microvessel density in the patients with Graves' disease. J Clin Endocrinol Metab. 2007 Jun;92(6):2182-9. doi: 10.1210/jc.2007-0229. Epub 2007 Mar 27.

  PMID: 17389702 RESULT

• Yilmaz Y, Kamer KE, Ureyen O, Sari E, Acar T, Karahalli O. The effect of preoperative Lugol's iodine on intraoperative bleeding in patients with hyperthyroidism. Ann Med Surg (Lond). 2016 Jun 16;9:53-7. doi: 10.1016/j.amsu.2016.06.002. eCollection 2016 Aug.

  PMID: 27408715 RESULT

• Shinall MC Jr, Broome JT, Nookala R, Shinall JB, Kiernan C, Parks L 3rd, Solorzano CC. Total thyroidectomy for Graves' disease: compliance with American Thyroid Association guidelines may not always be necessary. Surgery. 2013 Nov;154(5):1009-15. doi: 10.1016/j.surg.2013.04.064. Epub 2013 Sep 26.

  PMID: 24075271 RESULT

• Huang SM, Liao WT, Lin CF, Sun HS, Chow NH. Effectiveness and Mechanism of Preoperative Lugol Solution for Reducing Thyroid Blood Flow in Patients with Euthyroid Graves' Disease. World J Surg. 2016 Mar;40(3):505-9. doi: 10.1007/s00268-015-3298-8.

  PMID: 26546192 RESULT

• Yabuta T, Ito Y, Hirokawa M, Fukushima M, Inoue H, Tomoda C, Higashiyama T, Kihara M, Uruno T, Takamura Y, Kobayashi K, Miya A, Matsuzuka F, Miyauchi A. Preoperative administration of excess iodide increases thyroid volume of patients with Graves' disease. Endocr J. 2009;56(3):371-5. doi: 10.1507/endocrj.k08e-240. Epub 2009 Jan 9.

  PMID: 19139595 RESULT

• Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.

  PMID: 27797318 RESULT

• Ansaldo GL, Pretolesi F, Varaldo E, Meola C, Minuto M, Borgonovo G, Derchi LE, Torre GC. Doppler evaluation of intrathyroid arterial resistances during preoperative treatment with Lugol's iodide solution in patients with diffuse toxic goiter. J Am Coll Surg. 2000 Dec;191(6):607-12. doi: 10.1016/s1072-7515(00)00755-9.

  PMID: 11129808 RESULT

• Erbil Y, Giris M, Salmaslioglu A, Ozluk Y, Barbaros U, Yanik BT, Kapran Y, Abbasoglu SD, Ozarmagan S. The effect of anti-thyroid drug treatment duration on thyroid gland microvessel density and intraoperative blood loss in patients with Graves' disease. Surgery. 2008 Feb;143(2):216-25. doi: 10.1016/j.surg.2007.07.036. Epub 2007 Dec 21.

  PMID: 18242338 RESULT

• Schiavone D, Crimi F, Cabrelle G, Pennelli G, Sacchi D, Mian C, Torresan F, Iacobone M. Role of Lugol solution before total thyroidectomy for Graves' disease: randomized clinical trial. Br J Surg. 2024 Aug 2;111(8):znae196. doi: 10.1093/bjs/znae196.

  PMID: 39129619 DERIVED

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maurizio Iacobone, Prof

  University of Padova

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FEBS (Endocrine Surgery), Associate Professor, Head in Chief of Endocrine Surgery Unit of Padua University Hospital, Italy

Model Details: Case-Control study

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 27, 2023
• Study Start: February 1, 2020
• Primary Completion: January 26, 2023
• Study Completion: April 26, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)