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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04108923
Other study ID # Hemostasis in thyroidectomy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date April 1, 2021

Study information

Verified date January 2020
Source Assiut University
Contact Abadeer Rizallah
Phone +201289028410
Email dr.abadeermarsis@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ligasure
the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall
Procedure:
Conventional vessel ligation
Conventional vessel ligation either tying and /or clipping of blood vessels

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

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. Review. — View Citation

Peker K, Dumanli Ozcan AT, Sahin M, Inal A, Kiliç K, Özçiçek 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. — View Citation

Vidal O, Saavedra-Perez D, Valentini M, Astudillo E, Fernández-Cruz L, García-Valdecasas JC. Surgical outcomes of total thyroidectomy using the LigaSureā„¢ Small Jaw versus LigaSure Preciseā„¢: 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative blood loss Measuring intraoperative blood loss using surgical towels and contents of suction.
Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "
Baseline
Primary Post-operative blood loss Measuring postoperative blood loss by measuring contents of drains From skin closure until one week post operatively
Primary Post-operative complications Including RLN palsy , hypocalcemia , hemorrhage wound infection Postoperatively from day of surgery until one week post operatively
Primary Operation time From skin incision to skin closure Baseline
Secondary Length of hospital stay Measuring number of days of patient stay in hospital to be pain- free return to activity and work.
From day of surgery until discharge
Baseline up to two weeks
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