NCT00946894

Brief Summary

The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

July 27, 2009

Status Verified

July 1, 2009

Enrollment Period

3.9 years

First QC Date

July 23, 2009

Last Update Submit

July 24, 2009

Conditions

Goiter

Keywords

Total thyroidectomySubtotal thyroidectomyDunhill operationRecurrent nodular goiterCompletion thyroidectomyRecurrent laryngeal nerve palsyHypoparathyroidism following thyroidectomyRecurrent goiter

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.

    at 12, 24, 36, 48 and 60 months after surgery

Secondary Outcomes (1)

  • Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).

    at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery

Study Arms (3)

Total thyroidectomy

EXPERIMENTAL

Patients who underwent total thyroidectomy

Procedure: Total thyroidectomy

Dunhill operation

EXPERIMENTAL

Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Procedure: Dunhill operation

Bilateral subtotal thyroidectomy

ACTIVE COMPARATOR

Patients who underwent bilateral subtotal thyroidectomy

Procedure: Bilateral subtotal thyroidectomy

Interventions

Total thyroidectomyPROCEDURE

Total thyroidectomy

Also known as: TT
Total thyroidectomy
Dunhill operationPROCEDURE

Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Also known as: DO
Dunhill operation
Bilateral subtotal thyroidectomyPROCEDURE

Bilateral subtotal thyroidectomy

Also known as: BST
Bilateral subtotal thyroidectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • multinodular goiter involving posterior aspect/s of thyroid lobe/s,
  • suspicion of thyroid cancer,
  • previous thyroid surgery,
  • thyroiditis,
  • subclinical or clinically overt hypothyroidism or hyperthyroidism,
  • pregnancy or lactation,
  • age \< 18 years or \> 65 years,
  • ASA 4 grade (American Society of Anesthesiology),
  • inability to comply with the follow-up protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery

Krakow, 31-202, Poland

Location

Related Publications (10)

  • Snook KL, Stalberg PL, Sidhu SB, Sywak MS, Edhouse P, Delbridge L. Recurrence after total thyroidectomy for benign multinodular goiter. World J Surg. 2007 Mar;31(3):593-8; discussion 599-600. doi: 10.1007/s00268-006-0135-0.

    PMID: 17308855BACKGROUND

  • Wheeler MH. Total thyroidectomy for benign thyroid disease. Lancet. 1998 May 23;351(9115):1526-7. doi: 10.1016/S0140-6736(05)61116-6. No abstract available.

    PMID: 10326531BACKGROUND

  • Ozbas S, Kocak S, Aydintug S, Cakmak A, Demirkiran MA, Wishart GC. Comparison of the complications of subtotal, near total and total thyroidectomy in the surgical management of multinodular goitre. Endocr J. 2005 Apr;52(2):199-205. doi: 10.1507/endocrj.52.199.

    PMID: 15863948BACKGROUND

  • Moalem J, Suh I, Duh QY. Treatment and prevention of recurrence of multinodular goiter: an evidence-based review of the literature. World J Surg. 2008 Jul;32(7):1301-12. doi: 10.1007/s00268-008-9477-0.

    PMID: 18305998BACKGROUND

  • Tezelman S, Borucu I, Senyurek Giles Y, Tunca F, Terzioglu T. The change in surgical practice from subtotal to near-total or total thyroidectomy in the treatment of patients with benign multinodular goiter. World J Surg. 2009 Mar;33(3):400-5. doi: 10.1007/s00268-008-9808-1.

    PMID: 18958517BACKGROUND

  • Agarwal G, Aggarwal V. Is total thyroidectomy the surgical procedure of choice for benign multinodular goiter? An evidence-based review. World J Surg. 2008 Jul;32(7):1313-24. doi: 10.1007/s00268-008-9579-8.

    PMID: 18449595BACKGROUND

  • Phitayakorn R, McHenry CR. Follow-up after surgery for benign nodular thyroid disease: evidence-based approach. World J Surg. 2008 Jul;32(7):1374-84. doi: 10.1007/s00268-008-9487-y.

    PMID: 18311576BACKGROUND

  • Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.

    PMID: 19177420BACKGROUND

  • Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Nowak W. Ten-Year Follow-Up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter. World J Surg. 2018 Feb;42(2):384-392. doi: 10.1007/s00268-017-4230-1.

    PMID: 28942461DERIVED

  • Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Cichon S, Nowak W. Five-year follow-up of a randomized clinical trial of total thyroidectomy versus Dunhill operation versus bilateral subtotal thyroidectomy for multinodular nontoxic goiter. World J Surg. 2010 Jun;34(6):1203-13. doi: 10.1007/s00268-010-0491-7.

    PMID: 20174803DERIVED

MeSH Terms

Conditions

GoiterGoiter, NodularVocal Cord Paralysis

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcin Barczynski, MD, PhD

    Jagiellonian University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

January 1, 2000

Primary Completion

December 1, 2003

Study Completion

December 1, 2008

Last Updated

July 27, 2009

Record last verified: 2009-07

Locations

PL(1)