Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04577664
Collaborator
(none)
60
2
13

Study Details

Study Description

Brief Summary

The main aim of work is to compare between subtotal and total thyroidectomy intra and postoperatively to identify which technique is better for patient of graves disease

Condition or Disease Intervention/Treatment Phase
  • Procedure: total thyroidectomy
  • Procedure: subtotal thyroidectomy
N/A

Detailed Description

Graves' disease is an autoimmune disease that affects the thyroid gland[1] and it's the most common cause of hyperthyroidism. [2] Treatment of Graves' disease includes antithyroid drugs ; radioiodine ; and thyroidectomy . patients with Graves' hyperthyroidism can be treated with any of these treatment options. There is a wide geographic variation in the choice of therapy.[3] Medical treatment with antithyroid drugs is often accepted as first-choice modality in Europe, followed by radioiodine in case of recurrence. Although surgery offers the advantage of quick control and low morbidity in experienced hands, it is infrequently recommended as initial treatment. Therapy with radioiodine is the most common treatment in the United States, while antithyroid drugs and/or thyroidectomy are used more often in Europe, Japan, and most of the rest of the world.recent literature shows that the relapse rate was the highest among patients who received antithyroid drugs (40%) as compared to those who received radioiodine (21%) or Surgery (5). [4] Two different surgical techniques are used for the treatment of Graves' hyperthyroidism: a total thyroidectomy (TT) in which the entire gland is removed and a subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams. Although thyroidectomy has been broadly considered as a viable alternative theapy for patients with Graves' disease , the resection extent and remnant size of thyroid gland remains controversial.[6] Although total thyroidectomy has a lower recurrence rate it has raised a concern that a more radical operation would increase the complications.[7] we intend to perform this analysis based on the published literatures of randomized controlled trials to evaluate the specific risks of thyroid surgery including recurrent hyperthyroididm , post-operative bleeding , recurrent laryngeal nerve injury , hypoparathyroidism and opthalmopathy progression.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Total Versus Subtotal Thyroidectomy in Graves' Disease : A Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TT group

Procedure: total thyroidectomy
a total thyroidectomy (TT) in which the entire gland is removed

Active Comparator: ST group

Procedure: subtotal thyroidectomy
subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams.

Outcome Measures

Primary Outcome Measures

  1. comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease [baseline]

    Prevlance of recurrent hyperthyroidism

Secondary Outcome Measures

  1. comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease [baseline]

    Postoperative hypocalcemia and hypoparathyroidism.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patients diagnosed clinically, biochemically and immunologically with Graves' disease who will undergo thyroidectomy at general surgery department in AUH.
Exclusion Criteria:
  • 1- previous thyroid or parathyroid surgery.

  • 2- recurrent hyperthyroidism after radioiodine therapy.

  • 3- preoperative recurrent laryngeal nerve palsy.

  • 4- patients unfit for operation.

  • 5- inability to comply with the follow-up protocol.

  • 6- suspicious thyroid nodules.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ahmed Nasr, resident doctor at general surgery department, Assiut University
ClinicalTrials.gov Identifier:
NCT04577664
Other Study ID Numbers:
  • Thyroid surgery
First Posted:
Oct 8, 2020
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2020