Clinical trial NCT05567432: Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
Official title: Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In about 20 participants , the investigators will control bleeding and cut tissues and blood vessels using the diathermy and in the other 20 , investigators will do homeostasis with ligasure.
Primary purpose: TREATMENT

Brief summary: Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres.

Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

Detailed description: Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .

Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

Eligibility criteria: Inclusion Criteria:

* • Patient with disburbed thyroid function and candidate for for thyroidectomy

Exclusion Criteria:

* Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.

Primary outcomes:
measure: Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assut University
name: Mohamed Korany, PHD
role: STUDY_DIRECTOR
References:
citation: Manouras A, Markogiannakis H, Koutras AS, Antonakis PT, Drimousis P, Lagoudianakis EE, Kekis P, Genetzakis M, Koutsoumanis K, Bramis I. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg. 2008 Jan;195(1):48-52. doi: 10.1016/j.amjsurg.2007.01.037.