Evidence map›Paper›PMID 39129619›Full record

Trial reportThe British journal of surgery2024

Role of Lugol solution before total thyroidectomy for Graves' disease: randomized clinical trial.

Donatella Schiavone, Filippo Crimì, Giulio Cabrelle, Gianmaria Pennelli, Diana Sacchi, Caterina Mian, Francesca Torresan, Maurizio Iacobone

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05784792 (Clinical and Surgical Outcomes of Total Thyroidectomy in Basedow's Disease), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05784792 naunknown statusnot on this map

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

TypeinterventionalSponsorUniversity of PadovaRan2020 to 2024Enrolled50ConditionsBasedow DiseaseArmsLugol -
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Donatella SchiavoneDepartment of Surgery, Oncology and Gastroenterology, Endocrine Surgery Unit, University of Padua, Padua, Italy.
Filippo CrimìDepartment of Medicine, Institute of Radiology, University of Padua, Padua, Italy.
Giulio CabrelleDepartment of Medicine, Institute of Radiology, University of Padua, Padua, Italy.
Gianmaria PennelliDepartment of Medicine, Pathology Unit, University of Padua, Padua, Italy.
Diana SacchiDepartment of Pathology, Azienda ULSS2, Marca Trevigiana, Treviso, Italy.
Caterina MianDepartment of Medicine, Endocrinology Unit, University of Padua, Padua, Italy.ORCID 0000-0003-2615-8001
Francesca TorresanDepartment of Surgery, Oncology and Gastroenterology, Endocrine Surgery Unit, University of Padua, Padua, Italy.
Maurizio IacoboneDepartment of Surgery, Oncology and Gastroenterology, Endocrine Surgery Unit, University of Padua, Padua, Italy.ORCID 0000-0002-6057-4642

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLugol solution is often administered to patients with Graves' disease before surgery. The aim is to reduce thyroid vascularization and surgical morbidity, but its real effectiveness remains controversial. The present study was designed to evaluate the effects of preoperative Lugol solution on thyroid vascularization and surgical morbidity in patients with Graves' disease undergoing total thyroidectomy.

methodsFifty-six patients undergoing total thyroidectomy for Graves' disease were randomly assigned to receive 7 days of Lugol treatment (Lugol+ group, 29) or no Lugol treatment (LS- group, 27) before surgery in this single-centre and single-blinded trial. Preoperative hormone and colour Doppler ultrasonographic data for assessing thyroid vascularization were collected 8 days before surgery (T0) and on the day of surgery (T1). The primary outcome was intraoperative and postoperative blood loss. Secondary outcomes included duration of surgery, thyroid function, morbidity, vascularization, and microvessel density at final pathology.

resultsNo differences in demographic, preoperative hormone or ultrasonographic data were found between LS+ and LS- groups at T0. At T1, free tri-iodothyronine (FT3) and free thyroxine (FT4) levels were significantly reduced compared with T0 values in the LS+ group, whereas no such variation was observed in the LS- group. No differences between T0 and T1 were found for ultrasonographic vascularization in either group, nor did the histological findings differ. There were no significant differences between the LS+ and LS- groups concerning intraoperative/postoperative blood loss (median 80.5 versus 94 ml respectively), duration of surgery (75 min in both groups) or postoperative morbidity.

conclusionLugol solution significantly reduces FT3 and FT4 levels in patients undergoing surgery for Graves' disease, but does not decrease intraoperative/postoperative blood loss, thyroid vascularization, duration of surgery or postoperative morbidity. REGISTRATION NUMBER: NCT05784792 (https://www.clinicaltrials.gov).

Indexed as

Graves DiseaseIodidesThyroidectomyThyroid GlandAdultBlood Loss, SurgicalFemaleHumansMaleMiddle AgedOperative TimePreoperative CareSingle-Blind MethodThyroxineTreatment OutcomeUltrasonography, Doppler, ColorIodidesLugol's solutionThyroxine

Identifiers

PMID39129619
PMCPMC11977759

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.