Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05567432

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid	Procedure: thyroidectomy	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients will do throidectomy using diathermy In these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy .	Procedure: thyroidectomy use diathermy or ligasure for homeostatic during thyroidectomy
Active Comparator: Patients will do thyroidectomy using ligasure . In these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure.	Procedure: thyroidectomy use diathermy or ligasure for homeostatic during thyroidectomy

Arm

Intervention/Treatment

Active Comparator: Patients will do throidectomy using diathermy

In these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy .

Procedure: thyroidectomy

use diathermy or ligasure for homeostatic during thyroidectomy

Active Comparator: Patients will do thyroidectomy using ligasure .

In these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure.

Procedure: thyroidectomy

use diathermy or ligasure for homeostatic during thyroidectomy

Outcome Measures

Primary Outcome Measures

Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy [6 months]
This study is aiming to make a comparison between the incidence of intraoperative and postoperative bleeding while using diathermy versus using ligasure in homeostasis during thyroidectomy. The investigators will do their best to answer this question... 1. ls rate of postoperative complications decrease while using the ligasure than using traditional diathermy ?

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Mohamed Korany, PHD, Assut University

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Mahmoud Mohamed Aboelhassan Guishy, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05567432

Other Study ID Numbers:

htdl

First Posted:

Oct 5, 2022

Last Update Posted:

Oct 5, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperthermia

Study Results

No Results Posted as of Oct 5, 2022