Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases

Sponsor

Selcuk University (Other)

Overall Status

Completed

CT.gov ID

NCT04653376

Collaborator

(none)

Enrollment

Location

7.3

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tonsillar tissue is a significant organ for the performing of immune systems in children. The Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of the cells. The purpose of the study was to explore the correlation among ER stress and tonsillar tissue disorders and to explain the structure of diseases related to the immune system.

Condition or Disease	Intervention/Treatment	Phase
Tonsillitis Tonsillar Hypertrophy Immune System Diseases	Procedure: Tonsillectomy surgery

Detailed Description

A prospective study was conducted on 46 children aged who underwent tonsillectomy for chronic tonsillitis or tonsil hypertrophy. Tonsil tissues were evaluated in terms of ER stress markers and apoptosis markers by Real-time PCR and Western blot methods.

Study Design

Study Type:

Observational

Actual Enrollment :

46 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Possible Relationship Between Apoptosis and Endoplasmic Reticulum Stress in the Etiopathogenesis of Chronic Tonsillitis and Tonsillar Hypertrophy

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jun 10, 2019

Actual Study Completion Date :

Jun 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Chronic tonsillitis Patients with tonsil sizes grade 1 and 2, and tonsillectomy indications included frequently recurrent tonsillary infection, sore throat, and malodorous mouth problems were accepted as the chronic tonsillitis group.	Procedure: Tonsillectomy surgery The tonsillectomy procedure was performed under general anesthesia using the classical dissection method. Extracted tonsil tissue samples were sent to the medical genetics department in tubes to investigate the ER stress and apoptosis.
Tonsillar hypertrophy Patients with tonsil size grades 3 and 4 and tonsillectomy indications included obstructive symptoms such as snoring, open mouth breathing, difficulty in breathing, and swallowing problems were accepted as the tonsillar hypertrophy group.	Procedure: Tonsillectomy surgery The tonsillectomy procedure was performed under general anesthesia using the classical dissection method. Extracted tonsil tissue samples were sent to the medical genetics department in tubes to investigate the ER stress and apoptosis.

Arm

Intervention/Treatment

Chronic tonsillitis

Patients with tonsil sizes grade 1 and 2, and tonsillectomy indications included frequently recurrent tonsillary infection, sore throat, and malodorous mouth problems were accepted as the chronic tonsillitis group.

Procedure: Tonsillectomy surgery

The tonsillectomy procedure was performed under general anesthesia using the classical dissection method. Extracted tonsil tissue samples were sent to the medical genetics department in tubes to investigate the ER stress and apoptosis.

Tonsillar hypertrophy

Patients with tonsil size grades 3 and 4 and tonsillectomy indications included obstructive symptoms such as snoring, open mouth breathing, difficulty in breathing, and swallowing problems were accepted as the tonsillar hypertrophy group.

Procedure: Tonsillectomy surgery

Outcome Measures

Primary Outcome Measures

Relationship of Endoplasmic Reticulum stress and apoptosis with chronic tonsillitis and tonsillar hypertrophy [2018-2020]
Our primary outcome was to evaluate providing that Endoplasmic Reticulum stress and apoptosis reaction performing in chronic tonsillitis and tonsillar hypertropy, which is related with the immune system of children. GRP78, CHOP, ATF6, ATF4 proteins will be investigated in tonsillar tissues to evaluate ER stress index, and bax, bcl2 proteins will be investigated to evaluate apoptosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy.

Exclusion Criteria:

Systemic diseases
Other otolaryngological disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Selcuk University	Konya	Selcuklu	Turkey	42100

Sponsors and Collaborators

Selcuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Merih Onal, Assistant Professor, Selcuk University

ClinicalTrials.gov Identifier:

NCT04653376

Other Study ID Numbers:

2018/329

First Posted:

Dec 4, 2020

Last Update Posted:

Dec 4, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by Merih Onal, Assistant Professor, Selcuk University

Endoplasmic Reticulum

Apoptosis

İmmune system

Additional relevant MeSH terms:

Tonsillitis

Immune System Diseases

Hypertrophy

Study Results

No Results Posted as of Dec 4, 2020