Back to resultsSuction Diathermy Adenoidectomy (SDA) : Efficacy and Safety (SDA)
Primary Purpose
Adenoidectomy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suction Diathermy Adenoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Adenoidectomy
Eligibility Criteria
Inclusion Criteria: Obstructive symptoms such as long-lasting nocturnal snoring, sleep apnea, and open mouth breathing, bilateral nasal obstruction, and/or bilateral nasal discharge. Adenoid hypertrophy is the only cause of nasal obstruction. Radiography evidence of adenoid hypertrophy encroaching on the airway column. Age under 15 years. Sex: both males and females. All patients are generally well and fit for surgery. Exclusion Criteria: Presence of chronic diseases such as chronic heart diseases, chronic liver diseases, chronic renal diseases, and diabetes mellitus. Patients with other causes of nasal obstruction such as acute rhinitis, allergic rhinitis, septal deviation, inferior turbinate hypertrophy, antrochoanal polyp, nasal polypi or anatomical deformities (Choanal atresia). Cases with submucous cleft palate and cases with a previous history of cleft palate repair. Patients with bleeding or coagulation defects. Patients with atrophic rhinitis. Patients with recurrent adenoid.
Sites / Locations
- Amr Hamed HashemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
Arm Description
suction diathermy adenoidectomy
Outcomes
Primary Outcome Measures
the efficacy of suction diathermy in completeness of adenoid removal
Flexible fibre optic nasopharyngoscope or zero degree nasal endoscope is used for evaluation of the nasopharynx and determine the adenoid remnant in percentage.
amount of intraoperative blood loss with suction diathermy adenoidectomy
amount of blood loss measured in cubic centimeter
Recurrence of symptoms
Flexible fibre optic nasopharyngoscope or 0 degree nasal endoscope is used for evaluation of the nasopharynx to detect any remnant or recurrence of adenoid in percentage
postoperative hemorrhage
percentage of occurence of post operative hemorrhage
Secondary Outcome Measures
Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy
evaluated using zero degree nasal endoscope
Postoperative pain
pain is assessed using postoperative diary and pain is rated on a 0-10 visual analogue scale, 0 being no pain; and 10 being worse pain ever.
postoperative halitosis
halitosis is assessed using postoperative diary and halitosis is rated on 0-10 visual analogue scale, 0 being no odour, and 10 being the worst odour they have encountered
operative time with suction diathermy adenoidectomy
operative time measured in minutes
Speech changes
detection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05615506
Brief Title
Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety
Acronym
SDA
Official Title
Suction Diathermy Adenoidectomy : Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this prospective study is to evaluate the efficacy and safety of endoscopic suction diathermy adenoidectomy as regard the operative time, adenoid tissue remnant, blood loss, and clinical events like pain, halitosis, postoperative hemorrhage, speech changes and recurrence.
Detailed Description
Suction diathermy adenoidectomy is a procedure that uses thermal energy generated by electric current to ablate adenoid which is removed using suction. This procedure was described in 1997 and the technique has the advantage of complete tissue removal with reduced blood loss and intraoperative time, also reduced post-operative complications as postoperative hemorrhage , nasality and lower recurrence rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients under 15 years old who are scheduled to undergo elective adenoidectomy with or without ventilation tube application. , selected randomly, with symptoms and signs suggestive of adenoid hypertrophy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Arm Description
suction diathermy adenoidectomy
Intervention Type
Procedure
Intervention Name(s)
Suction Diathermy Adenoidectomy
Intervention Description
suction diathermy adenoidectomy
Primary Outcome Measure Information:
Title
the efficacy of suction diathermy in completeness of adenoid removal
Description
Flexible fibre optic nasopharyngoscope or zero degree nasal endoscope is used for evaluation of the nasopharynx and determine the adenoid remnant in percentage.
Time Frame
intraoperative
Title
amount of intraoperative blood loss with suction diathermy adenoidectomy
Description
amount of blood loss measured in cubic centimeter
Time Frame
intraoperative
Title
Recurrence of symptoms
Description
Flexible fibre optic nasopharyngoscope or 0 degree nasal endoscope is used for evaluation of the nasopharynx to detect any remnant or recurrence of adenoid in percentage
Time Frame
6 months
Title
postoperative hemorrhage
Description
percentage of occurence of post operative hemorrhage
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy
Description
evaluated using zero degree nasal endoscope
Time Frame
6 months
Title
Postoperative pain
Description
pain is assessed using postoperative diary and pain is rated on a 0-10 visual analogue scale, 0 being no pain; and 10 being worse pain ever.
Time Frame
7 days
Title
postoperative halitosis
Description
halitosis is assessed using postoperative diary and halitosis is rated on 0-10 visual analogue scale, 0 being no odour, and 10 being the worst odour they have encountered
Time Frame
7 days
Title
operative time with suction diathermy adenoidectomy
Description
operative time measured in minutes
Time Frame
6 months
Title
Speech changes
Description
detection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obstructive symptoms such as long-lasting nocturnal snoring, sleep apnea, and open mouth breathing, bilateral nasal obstruction, and/or bilateral nasal discharge.
Adenoid hypertrophy is the only cause of nasal obstruction.
Radiography evidence of adenoid hypertrophy encroaching on the airway column.
Age under 15 years.
Sex: both males and females.
All patients are generally well and fit for surgery.
Exclusion Criteria:
Presence of chronic diseases such as chronic heart diseases, chronic liver diseases, chronic renal diseases, and diabetes mellitus.
Patients with other causes of nasal obstruction such as acute rhinitis, allergic rhinitis, septal deviation, inferior turbinate hypertrophy, antrochoanal polyp, nasal polypi or anatomical deformities (Choanal atresia).
Cases with submucous cleft palate and cases with a previous history of cleft palate repair.
Patients with bleeding or coagulation defects.
Patients with atrophic rhinitis.
Patients with recurrent adenoid.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amr h elsherif, resident
Phone
01093898351
Email
elsherifamr99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
elhussein a ali, a.professor
Facility Information:
Facility Name
Amr Hamed Hashem
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amr elsherif
Phone
01093898351
Email
elsherifamr99@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
1728896
Citation
Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. doi: 10.1177/00034894921010s106.
Results Reference
result
PubMed Identifier
10582114
Citation
Dinis PB, Haider H, Gomes A. The effects of adenoid hypertrophy and subsequent adenoidectomy on pediatric nasal airway resistance. Am J Rhinol. 1999 Sep-Oct;13(5):363-9. doi: 10.2500/105065899781367564.
Results Reference
result
PubMed Identifier
9578120
Citation
Clemens J, McMurray JS, Willging JP. Electrocautery versus curette adenoidectomy: comparison of postoperative results. Int J Pediatr Otorhinolaryngol. 1998 Mar 1;43(2):115-22. doi: 10.1016/s0165-5876(97)00159-6.
Results Reference
result
PubMed Identifier
17334301
Citation
Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10. doi: 10.1097/MLG.0b013e31802ffe47.
Results Reference
result
PubMed Identifier
22032788
Citation
Pagella F, Pusateri A, Canzi P, Caputo M, Marseglia A, Pelizzo G, Matti E. The evolution of the adenoidectomy: analysis of different power-assisted techniques. Int J Immunopathol Pharmacol. 2011 Oct;24(4 Suppl):55-9. doi: 10.1177/03946320110240S411.
Results Reference
result
PubMed Identifier
9055172
Citation
Wright ED, Manoukian JJ, Shapiro RS. Ablative adenoidectomy: a new technique using simultaneous liquefaction/aspiration. J Otolaryngol. 1997 Feb;26(1):36-43.
Results Reference
result
PubMed Identifier
20950511
Citation
Regmi D, Mathur NN, Bhattarai M. Rigid endoscopic evaluation of conventional curettage adenoidectomy. J Laryngol Otol. 2011 Jan;125(1):53-8. doi: 10.1017/S0022215110002100. Epub 2010 Oct 18.
Results Reference
result
PubMed Identifier
27340625
Citation
Agrawal V, Agarwal PK, Agrawal A. Defining the Surgical Limits of Adenoidectomy so as to Prevent Recurrence of Adenoids. Indian J Otolaryngol Head Neck Surg. 2016 Jun;68(2):131-4. doi: 10.1007/s12070-016-0971-7. Epub 2016 Mar 12.
Results Reference
result
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Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety
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