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Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04108923
Enrollment
80
Registered
2019-09-30
Start date
2020-03-01
Completion date
2021-04-01
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases

Keywords

Thyroidectomy, Ligasure, Vessel ligation

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

Interventions

DEVICELigasure

the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall

PROCEDUREConventional vessel ligation

Conventional vessel ligation either tying and /or clipping of blood vessels

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative blood lossBaselineMeasuring 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 lossFrom skin closure until one week post operativelyMeasuring postoperative blood loss by measuring contents of drains
Post-operative complicationsPostoperatively from day of surgery until one week post operativelyIncluding RLN palsy , hypocalcemia , hemorrhage wound infection
Operation timeBaselineFrom skin incision to skin closure

Secondary

MeasureTime frameDescription
Length of hospital stayBaseline up to two weeksMeasuring number of days of patient stay in hospital to be pain- free return to activity and work. From day of surgery until discharge

Contacts

Primary ContactAbadeer Rizallah
dr.abadeermarsis@gmail.com+201289028410

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026