AdenoidectomySDANCT05615506
Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety
A study testing Suction Diathermy Adenoidectomy in people with Adenoidectomy, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Adenoidectomy
- What is being tested?
- Suction Diathermy Adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
elhussein a ali, a.professor contact
Egypt1 site, 1 recruiting
- Recruiting
Amr Hamed Hashem
Sohag
amr elsherif, 01093898351, elsherifamr99@gmail.com
About this study
Official title: Suction Diathermy Adenoidectomy : Efficacy and Safety
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.
Read the 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.
- Conditions
- Adenoidectomy
- Being tested
- Suction Diathermy Adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction Diathermy AdenoidectomyProcedure or surgery
suction diathermy adenoidectomy
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | suction diathermy adenoidectomy Receives: Procedure: Suction Diathermy Adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
amount of intraoperative blood loss with suction diathermy adenoidectomy
amount of blood loss measured in cubic centimeter
Measured: intraoperative
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
Measured: 6 months
postoperative hemorrhage
percentage of occurence of post operative hemorrhage
Measured: 2 weeks
Secondary outcomes (5)
Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy
evaluated using zero degree nasal endoscope
Measured: 6 months
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.
Measured: 7 days
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
Measured: 7 days
operative time with suction diathermy adenoidectomy
operative time measured in minutes
Measured: 6 months
Speech changes
detection of open nasality and palatal assessment by Flexible fibre optic nasopharyngoscope after 3 weeks then 3 and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start12 Oct 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AdenoidectomyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hamed Hashem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615506
- Sponsor's protocol ID
- soh-med-22-10-10
- Acronym
- SDA
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. doi: 10.1177/00034894921010s106.
PubMed 1728896Dinis 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.
PubMed 10582114Clemens 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.
PubMed 9578120Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10. doi: 10.1097/MLG.0b013e31802ffe47.
PubMed 17334301Pagella 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.
PubMed 22032788Wright ED, Manoukian JJ, Shapiro RS. Ablative adenoidectomy: a new technique using simultaneous liquefaction/aspiration. J Otolaryngol. 1997 Feb;26(1):36-43.
PubMed 9055172Regmi 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.
PubMed 20950511Agrawal 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.
PubMed 27340625
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suction Diathermy Adenoidectomy : Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05615506
- Acronym / sponsor ID
- SDA / soh-med-22-10-10
- Conditions
- Adenoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Procedure: Suction Diathermy Adenoidectomysuction diathermy adenoidectomy |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction Diathermy Adenoidectomysuction diathermy adenoidectomy | Procedure or surgery | patients |
Primary outcome
the efficacy of suction diathermy in completeness of adenoid removal
Time frame: intraoperative
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
Time frame: intraoperative
amount of blood loss measured in cubic centimeter
Recurrence of symptoms
Time frame: 6 months
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
Time frame: 2 weeks
percentage of occurence of post operative hemorrhage
5 secondary outcomes
Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy
Time frame: 6 months
Postoperative pain
Time frame: 7 days
postoperative halitosis
Time frame: 7 days
operative time with suction diathermy adenoidectomy
Time frame: 6 months
Speech changes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Results publication: PubMed 1728896Gates GA, Muntz HR, Gaylis B. Adenoidectomy and otitis media. Ann Otol Rhinol Laryngol Suppl. 1992 Jan;155:24-32. doi: 10.1177/00034894921010s106.
- Results publication: PubMed 10582114Dinis 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 publication: PubMed 9578120Clemens 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 publication: PubMed 17334301Shapiro NL, Bhattacharyya N. Cold dissection versus coblation-assisted adenotonsillectomy in children. Laryngoscope. 2007 Mar;117(3):406-10. doi: 10.1097/MLG.0b013e31802ffe47.
- Results publication: PubMed 22032788Pagella 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 publication: PubMed 9055172Wright ED, Manoukian JJ, Shapiro RS. Ablative adenoidectomy: a new technique using simultaneous liquefaction/aspiration. J Otolaryngol. 1997 Feb;26(1):36-43.
- Results publication: PubMed 20950511Regmi 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 publication: PubMed 27340625Agrawal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elhussein a ali, a.professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction Diathermy Adenoidectomy in people with Adenoidectomy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amr h elsherif, resident (01093898351, elsherifamr99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of suction diathermy in completeness of adenoid removal (time frame: intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615506, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.