Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

NCT ID: NCT04108923

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-04-01

Brief Summary

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To compare between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate

Detailed Description

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The significant vascularity of the thyroid gland and the relatively small operative field makes meticulous hemostasis an important prerequisite in thyroid surgery for successful outcome. The mainstay for achieving hemostasis in thyroidectomy is tying and / or clipping of blood vessels. New technologies have been introduced , among them the vessel sealing device ( ligasure ) which seals vessels by fusing the inner layers of the vessel wall with minimal levels of thermal dispersion burning and tissue friction thereby reducing incidence of accidental burns . This study is designed to evaluate the safety and efficacy of using ligasure compared with conventional vessel ligation in open thyroid surgery

Conditions

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Thyroid Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ligasure ( group A)

Group Type ACTIVE_COMPARATOR

Ligasure

Intervention Type DEVICE

the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall

Conventional vessel ligation (group B)

Group Type ACTIVE_COMPARATOR

Conventional vessel ligation

Intervention Type PROCEDURE

Conventional vessel ligation either tying and /or clipping of blood vessels

Interventions

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Ligasure

the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall

Intervention Type DEVICE

Conventional vessel ligation

Conventional vessel ligation either tying and /or clipping of blood vessels

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
* Any age

Exclusion Criteria

* patient undergoing re-do surgery " completion thyroidectomy "
* patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abadeer Raafat Marsis Rizallah

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abadeer Rizallah

Role: CONTACT

+201289028410

References

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Youssef T, Mahdy T, Farid M, Latif AA. Thyroid surgery: use of the LigaSure Vessel Sealing System versus conventional knot tying. Int J Surg. 2008 Aug;6(4):323-7. doi: 10.1016/j.ijsu.2008.05.005. Epub 2008 May 23.

Reference Type BACKGROUND
PMID: 18585113 (View on PubMed)

Vidal O, Saavedra-Perez D, Valentini M, Astudillo E, Fernandez-Cruz L, Garcia-Valdecasas JC. Surgical outcomes of total thyroidectomy using the LigaSure Small Jaw versus LigaSure Precise: A retrospective study of 2000 consecutive patients. Int J Surg. 2017 Jan;37:8-12. doi: 10.1016/j.ijsu.2016.08.241. Epub 2016 Aug 23.

Reference Type BACKGROUND
PMID: 27565244 (View on PubMed)

Luo Y, Li X, Dong J, Sun W. A comparison of surgical outcomes and complications between hemostatic devices for thyroid surgery: a network meta-analysis. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1269-1278. doi: 10.1007/s00405-016-4190-3. Epub 2016 Aug 1.

Reference Type BACKGROUND
PMID: 27481528 (View on PubMed)

Peker K, Dumanli Ozcan AT, Sahin M, Inal A, Kilic K, Ozcicek F. A comparison of total thyroidectomies carried out through LigaSure and Harmonic Scalpel: a retrospective study. Turk J Med Sci. 2014;44(2):255-60. doi: 10.3906/sag-1210-94.

Reference Type BACKGROUND
PMID: 25536733 (View on PubMed)

Other Identifiers

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Hemostasis in thyroidectomy

Identifier Type: -

Identifier Source: org_study_id

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