Trial no.:	PACTR202412878247105	Date of Registration:	23/12/2024
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Endoscopic adenoidectomy in pediatrics using suction diathermy versus Coblation technique

Official scientific title

Endoscopic adenoidectomy in pediatrics using suction diathermy versus Coblation technique; Randomized clinical trial

Brief summary describing the background and objectives of the trial

Adenoidectomy is a highly common procedure among children. Various techniques have been developed for performing this operation. This study aimed to compare the effectiveness of two popular methods: endoscopic adenoidectomy using suction diathermy and the Coblation technique

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Ear, Nose and Throat

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Surgery

Anticipated trial start date

01/12/2023

Actual trial start date

01/12/2023

Anticipated date of last follow up

16/07/2024

Actual Last follow-up date

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register
MSCAZASTENT03016	Alazhar assiut faculty of medicine institunional review board

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Permuted block randomization	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Endoscopic Adenoidectomy by coblation		8 months	Thirty patients underwent Coblation-assisted adenoidectomy. The child was placed in Rose's position to retract the soft palate and improve the visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally using a clamp. The COBLATOR™ II surgery system Model EC8000-01 (ArthroCare Corp, Sunnyvale, CA, USA) was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, Coblation was performed using a 4 mm, 70-degree angled endoscope inserted trans orally or a zero-degree endoscope inserted transnasally, for effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes	30
Control Group	Endoscopic Adenoidectomy by suction diathermy		8 months	Thirty patients underwent a suction diathermy adenoidectomy procedure. The soft palate was retracted using two suction catheters, allowing a 70-degree angled endoscope placed in the oropharynx to directly visualize the adenoidal tissue and surrounding structures in the nasopharynx. The adenoidal tissue was then ablated using a malleable size 10 or 12 French hand-switching suction coagulator, starting at the most superior part of the tissue. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth contour. Care was taken to avoid injury to the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either trans orally or transnasally, helped to minimize any thermal injury caused by the diathermy machine	30	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
patients aged between two - eighteen years old patients who had isolated adenoid hypertrophy Hemoglobin Level above 10 gm/dl	Recent upper respiratory tract infections Evidence of bleeding disorders Those with serous otitis media and chronic tonsillitis Patients with atrophic rhinitis, Those with nasal obstruction caused by other conditions like inferior turbinate hypertrophy, deviated nasal septum, or antrochoanal polyp	Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year	2 Year(s)	18 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

09/01/2024

Alazhar univeristy faculty of medicine

Ethics Committee Address
Street address	City	Postal code	Country
Alazhar street	assiut	75100	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Intraoperaive blood loss	Intraoperative
Primary Outcome	Operative time	Intraoperive
Primary Outcome	Postoperative pain using visual analogue scale	Postoperative
Secondary Outcome	Recovery time	Postoperative
Secondary Outcome	Secondary bleeding	Postoperative
Secondary Outcome	Residual adenoid tissue	Postoperative

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
AlAzhar	Alazhar street	Assiut		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
university	alazhar street	assiut		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	alazhar university faculty of medicine hospital	alazhar street	assiut		Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Yousry othman abdelrahman	yosryent2012@yahoo.com	01154678910	elorouba street
City	Postal code	Country	Position/Affiliation
sohag		Egypt	professor and head of department of otorhinolarngology at alazhar university faculty of medicne hospital
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mahmoud ibrahim elawamry	tabeb_garrah83@yahoo.com	01001349506	alazhar street
City	Postal code	Country	Position/Affiliation
assiut		Egypt	lecturer of otorhinolarngogy at alazhar university faculty of medicine hospital
Role	Name	Email	Phone	Street address
Public Enquiries	Moahmmed ahmed hussien	Mswwafey@gmail.com	01145153905	elorubuia street
City	Postal code	Country	Position/Affiliation
sohag		Egypt	Lecturer of otorhinolarngogy at alazhar univeristy faculty of medicine hospital

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	individual participants data that underlie the results reported in this article after deidentification ( tables, figures, and text )	Study Protocol	immediately after Publication, No end date	researchers who provide methodology sound proposal
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	03/12/2024	as required by PACTR	Comaprtive clinical trial between two approches in Adenoidectomy one of them suction diathermy and the other is Coblation Adenoidectomy	Adenoidectomy is a highly common procedure among children. Various techniques have been developed for performing this operation. This study aimed to compare the effectiveness of two popular methods: endoscopic adenoidectomy using suction diathermy and the Coblation technique
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Actual trial start date	03/12/2024	PACTR Admin		01 Dec 2023
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Study Design	Block size	03/12/2024	AS REQUIRED BY pactr	Block size 4 not vairable	Block size 4 AND THE BLOCK SIZE NOT VAIRABLE
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Inclusion criteria	03/12/2024	as required by PACTR	We included all patients aged two to eighteen years who had isolated adenoid hypertrophy	patients aged between two - eighteen years old patients who had isolated adenoid hypertrophy Hemoglobin Level above 10 gm/dl
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Exclusion criteria	03/12/2024	as required by PACTR	We had to exclude certain patients from the study. This included those with recent upper respiratory tract infections, evidence of bleeding disorders, those with serous otitis media and chronic tonsillitis, patients advised against undergoing adenoidectomy after consulting a phoniatrist, patients with atrophic rhinitis, and those with nasal obstruction caused by other conditions like inferior turbinate hypertrophy, deviated nasal septum, or antrochoanal polyp	Recent upper respiratory tract infections Evidence of bleeding disorders Those with serous otitis media and chronic tonsillitis Patients with atrophic rhinitis, Those with nasal obstruction caused by other conditions like inferior turbinate hypertrophy, deviated nasal septum, or antrochoanal polyp
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	03/12/2024	as required by PACTR	Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year	Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year
Section Name	Field Name	Date	Reason	Old Value	Updated Value
SecondaryID	SecondaryID List	03/12/2024	as required by PACTR		MSCAZASTENT03016, Alazhar assiut faculty of medicine institunional review board
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	03/12/2024	AS REQUIRED BY PACTR	Experimental Group, Endoscopic Adenoidectomy by coblation, , 8 months , Endoscopic Adenoidectomy by coblation device , 30,	Experimental Group, Endoscopic Adenoidectomy by coblation, , 8 months , Thirty patients underwent Coblation-assisted adenoidectomy. The child was placed in Rose's position to retract the soft palate and improve the visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally using a clamp. The COBLATOR™ II surgery system Model EC8000-01 (ArthroCare Corp, Sunnyvale, CA, USA) was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, Coblation was performed using a 4 mm, 70-degree angled endoscope inserted trans orally or a zero-degree endoscope inserted transnasally, for effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes, 30,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	03/12/2024	as rquired by PACTR	Control Group, Endoscopic Adenoidectomy by suction diathermy, , 8 months, Endoscopic Adenoidectomy by suction diathermy , 30, Active-Treatment of Control Group	Control Group, Endoscopic Adenoidectomy by suction diathermy, , 8 months, Thirty patients underwent a suction diathermy adenoidectomy procedure. The soft palate was retracted using two suction catheters, allowing a 70-degree angled endoscope placed in the oropharynx to directly visualize the adenoidal tissue and surrounding structures in the nasopharynx. The adenoidal tissue was then ablated using a malleable size 10 or 12 French hand-switching suction coagulator, starting at the most superior part of the tissue. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth contour. Care was taken to avoid injury to the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either trans orally or transnasally, helped to minimize any thermal injury caused by the diathermy machine, 30, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	03/12/2024	as required by PACTR	TRUE, Alazhar univeristy faculty of medicine , Alazhar street , assiut, 75100, Egypt, , 05 Jan 2024, 0201555950457, jonesalbino68@gmail.com, 32166_30274_4737.pdf	TRUE, Alazhar univeristy faculty of medicine , Alazhar street , assiut, 75100, Egypt, , 05 Jan 2024, 0201555950457, jonesalbino68@gmail.com, 32166_30274_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	03/12/2024	as required by PACTR	TRUE, Alazhar univeristy faculty of medicine , Alazhar street , assiut, 75100, Egypt, , 05 Jan 2024, 0201555950457, jonesalbino68@gmail.com, 32166_30274_4737.pdf	TRUE, Alazhar univeristy faculty of medicine , Alazhar street , assiut, 75100, Egypt, , 09 Jan 2024, 0201555950457, jonesalbino68@gmail.com, 32166_30274_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	10/12/2024	as required by PACTR	TRUE, Alazhar univeristy faculty of medicine , Alazhar street , assiut, 75100, Egypt, , 09 Jan 2024, 0201555950457, jonesalbino68@gmail.com, 32166_30274_4737.pdf	TRUE, Alazhar univeristy faculty of medicine , Alazhar street , assiut, 75100, Egypt, , 09 Jan 2024, 0201555950457, ethicscommitte@azhar.edu.eg, 32166_30274_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	03/12/2024	As required by PACTR	all included patients aged between two to eighteen years old, all data will be available	- IPD data collected from participants will be available after identification - individual data will include text, tables, and figures - also, the document will include the study protocol and statistical analysis plan - data will be available immediately after publication with researchers who provide methodology sound proposal - Proposal should be directed to " Jonesalbino68@gmail.com " to gain access to data
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	10/12/2024	as required by PACTR	- IPD data collected from participants will be available after identification - individual data will include text, tables, and figures - also, the document will include the study protocol and statistical analysis plan - data will be available immediately after publication with researchers who provide methodology sound proposal - Proposal should be directed to " Jonesalbino68@gmail.com " to gain access to data	the document will include the study protocol and statistical analysis plan - data will be available immediately after publication with researchers who provide methodology sound proposal - Proposal should be directed to " Jonesalbino68@gmail.com " to gain access to data
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	17/12/2024	As required by PACTR	the document will include the study protocol and statistical analysis plan - data will be available immediately after publication with researchers who provide methodology sound proposal - Proposal should be directed to " Jonesalbino68@gmail.com " to gain access to data	individual participants data that underlie the results reported in this article after deidentification ( tables, figures, and text )
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD-Sharing time frame	03/12/2024	As required by PACTR	data will be available at end of December 2024	immediately after publication
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD-Sharing time frame	17/12/2024	As required by PACTR	immediately after publication	immediately after Publication, No end date
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	17/12/2024	As required by PACTR	controlled	researchers who provide methodology sound proposal

Pan African Clinical Trials Registry