Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

NCT05567432 | Unknown

• 1 other identifier: htdl
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid

Outcome Measures

Primary Outcomes (1)

• Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy

  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 ?

  6 months

Study Arms (2)

Patients will do throidectomy using diathermy

ACTIVE COMPARATOR

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

Procedure: thyroidectomy

Patients will do thyroidectomy using ligasure .

ACTIVE COMPARATOR

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

Procedure: thyroidectomy

Interventions

thyroidectomy PROCEDURE

use diathermy or ligasure for homeostatic during thyroidectomy

Patients will do throidectomy using diathermy; Patients will do thyroidectomy using ligasure .

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with disburbed thyroid function and candidate for for thyroidectomy

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 18082542 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mohamed Korany, PHD

  Assut University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Aboelhassan, Master

CONTACT

00201024529525; mahmoudaboelhassen37@gmail.com

Mostafa Ibrahem, PHD

CONTACT

00201095295794; Mostafamahmoud5622@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: October 5, 2022
• Study Start: January 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 5, 2022

Record last verified: 2022-10