Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy
Study Details
Study Description
Brief Summary
To compare between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ligasure ( group A)
|
Device: Ligasure
the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall
|
| Active Comparator: Conventional vessel ligation (group B)
|
Procedure: Conventional vessel ligation
Conventional vessel ligation either tying and /or clipping of blood vessels
|
Outcome Measures
Primary Outcome Measures
- Intraoperative blood loss [Baseline]
Measuring intraoperative blood loss using surgical towels and contents of suction. Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "
- Post-operative blood loss [From skin closure until one week post operatively]
Measuring postoperative blood loss by measuring contents of drains
- Post-operative complications [Postoperatively from day of surgery until one week post operatively]
Including RLN palsy , hypocalcemia , hemorrhage wound infection
- Operation time [Baseline]
From skin incision to skin closure
Secondary Outcome Measures
- Length of hospital stay [Baseline up to two weeks]
Measuring number of days of patient stay in hospital to be pain- free return to activity and work. From day of surgery until discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
-
Any age
Exclusion Criteria:
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patient undergoing re-do surgery " completion thyroidectomy "
-
patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Peker K, Dumanli Ozcan AT, Şahin M, İnal 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.
- 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.
- 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.
- Hemostasis in thyroidectomy