Clinical trial NCT04108923: Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy
Official title: Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy " Randomised Controlled Study"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Diseases
Keywords: Thyroidectomy
Ligasure
Vessel ligation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: Baseline
measure: Post-operative blood loss
timeFrame: From skin closure until one week post operatively
measure: Post-operative complications
timeFrame: Postoperatively from day of surgery until one week post operatively
measure: Operation time
timeFrame: Baseline
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Baseline up to two weeks
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
citation: 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.
citation: 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.