Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

Thyroid Diseases Clinical Trial

Official title:

Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy " Randomised Controlled Study"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04108923
• Other study ID #: Hemostasis in thyroidectomy
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Thyroid Diseases

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 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. — 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