Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy " Randomised Controlled Study"
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 80
- Primary Endpoint
- Post-operative complications
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
Exclusion Criteria
- •patient undergoing re-do surgery " completion thyroidectomy "
- •patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
Outcomes
Primary Outcomes
Post-operative complications
Time Frame: Postoperatively from day of surgery until one week post operatively
Including RLN palsy , hypocalcemia , hemorrhage wound infection
Intraoperative blood loss
Time Frame: 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
Time Frame: From skin closure until one week post operatively
Measuring postoperative blood loss by measuring contents of drains
Operation time
Time Frame: Baseline
From skin incision to skin closure
Secondary Outcomes
- Length of hospital stay(Baseline up to two weeks)
Investigators
Abadeer Raafat Marsis Rizallah
Resident doctor
Assiut University