Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

NCT ID: NCT05567432

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Thyroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients will do throidectomy using diathermy

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

Group Type ACTIVE_COMPARATOR

thyroidectomy

Intervention Type PROCEDURE

use diathermy or ligasure for homeostatic during thyroidectomy

Patients will do thyroidectomy using ligasure .

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

Group Type ACTIVE_COMPARATOR

thyroidectomy

Intervention Type PROCEDURE

use diathermy or ligasure for homeostatic during thyroidectomy

Interventions

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thyroidectomy

use diathermy or ligasure for homeostatic during thyroidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Mohamed Aboelhassan Guishy

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Korany, PHD

Role: STUDY_DIRECTOR

Assut University

Central Contacts

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Mahmoud Aboelhassan, Master

Role: CONTACT

00201024529525

Mostafa Ibrahem, PHD

Role: CONTACT

00201095295794

References

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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.

Reference Type BACKGROUND
PMID: 18082542 (View on PubMed)

Other Identifiers

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htdl

Identifier Type: -

Identifier Source: org_study_id

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