CholesteatomaNCT03294421
Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy
A study testing combined access tympanomastoidectomy and standard closed tympanomastoidectomy in people with Cholesteatoma and Chronic Otitis Media, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Chronic otitis media is a prevalent medical condition, leading to important impact in the lives of the individuals with this condition, and a great amount of patients may need surgical intervention. Read more about this study
- Who is it for?
- Ages 5 to 90 years
- Conditions the study is for
- Cholesteatoma, Chronic Otitis Media
- What is being tested?
- combined access tympanomastoidectomy and standard closed tympanomastoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Sep 2017to 31 Aug 2020
- 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 5 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with cholesteatoma with indication for closed tympanomastoidectomy.
Who cannot join
- Patients with malformation of the temporal bone or previous surgery in the ear eligible for the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de clínicas de porto alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
Chronic otitis media is a prevalent medical condition, leading to important impact in the lives of the individuals with this condition, and a great amount of patients may need surgical intervention. The main objectives of the surgery in these cases are to restore the anatomy of the middle ear, to improve hearing and to remove the infection to avoid further complications. Still, chronic otitis media with cholesteatoma presents high rates of recurrence and residual symptoms after surgery.
The standard technique used for treatment of chronic otitis media is microsurgery. Nonetheless, with the development of new technologies that use endoscopy, it is now possible to use endoscopic surgery to improve the visualization of the cholesteatoma and ear structures by combining both techniques.
This study will evaluate the efficacy of the combined access surgery technique, which is microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with cholesteatoma. Furthermore, the study aims to compare the results of the combined access technique and the standard technique by randomizing the patients in two groups: one group will receive tympanomastoidectomy by standard technique and the other group will receive combined technique.
Read the detailed description
Patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be randomized into two groups. In the first group, microsurgical tympanomastoidectomy will be performed; while combined technique will be performed in the other group. The combined technique improves the visualization of the middle ear canal and the mastoid. Herewith, the best visualization of the surgical site facilitates the full removal of the cholesteatoma. In addition to that, the combined technique is less invasive than the standard one, since less bone debridement is required to access the surgical site.
The outcomes of the study will be evaluated through follow up medical appointments and exams. The patients will be followed by monthly medical appointments with otoscopic evaluations for diagnose of possible recurrence of the disease or residual cholesteatoma. Also, audiometry exams will be performed in the third, sixth and twelfth months. Image exams such as nuclear magnetic resonance may be performed at the end of this period to evaluate relapse of the disease if the otoscopic evaluation is inconclusive.
- Conditions
- Cholesteatoma, Chronic Otitis Media
- Being tested
- combined access tympanomastoidectomy, standard closed tympanomastoidectomy
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined access tympanomastoidectomyProcedure or surgery
Trans canal surgery with the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation allowing better visualization and removal of the cholesteatoma before mastoid debridement. In this surgery, mastoid debridement is conducted only if there was no full endoscopic removal of the cholesteatoma. The other procedures of this type of surgery are similar to the standard tympanomastoidectomy technique.
standard closed tympanomastoidectomyProcedure or surgery
- Supine position and general anesthesia with orotracheal intubation
- Antisepsis and placing of sterile fields
- Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI
- Retroauricular incision
- Removal of the temporal muscle fascia
- Elevation of the surgical flap of the tympanic meatus
- Visualization and exploration of the cholesteatoma
- Exploration of the ossicular chain
- Mastoid debridement
- Conservation of the upper posterior wall of the auditory conduct
- Removal of the cholesteatoma
- Tympanoplasty with the temporal fascia
- Retroauricular suture with vycril 3.0 and mononylon 4.0
| Study group | Role | What they receive |
|---|---|---|
| standard closed tympanomastoidectomy | Active comparator | In this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used. Receives: Procedure: standard closed tympanomastoidectomy |
| combined access tympanomastoidectomy | Experimental | In this group a closed tympanomastoidectomy with combined access will be performed. This technique combines the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation. Receives: Procedure: combined access tympanomastoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of cholesteatoma.
Recurrence of cholesteatoma, which is defined as development of new disease in the same ear (not related with the previous cholesteatoma), will be evaluated through second look surgery or nuclear magnetic resonance.
Measured: 12 months post intervention.
Residual cholesteatoma
Presence of residual cholesteatoma, which is defined as disease that was not fully removed in the first intervention, will be evaluated through second look surgery or nuclear magnetic resonance.
Measured: 12 months post intervention.
Secondary outcomes (4)
Hearing outcomes
Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: Pure tone average (PTA) 500.000 Hz to 2.000 Hz and air bone gap) after three months after surgery and compared with the audiometry exam made before the surgery.
Measured: 3 months post intervention.
Hearing outcomes
Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after six months after surgery and compared with the audiometry exam made before the surgery and the audiometry exam made three months after surgery.
Measured: 6 months post intervention.
Hearing outcomes
Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after twelve months after surgery and compared with the audiometry exam made before the surgery and the audiometry exams made three and six months after surgery.
Measured: 12 months post intervention.
Length of procedure
Compares the length of the closed tympanomastoidectomy with standard technique and the combined access tympanomastoidectomy.
Measured: measured in minutes from the surgical incision until the suture of the skin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start22 Sep 2017
- Primary completion7 May 2020
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CholesteatomaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sady S Da costa, Principal investigator, Hospital de Clinicas de Porto AlegreMauricio LS Da silva, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294421
- Sponsor's protocol ID
- 50571215.0.0000.5327
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2017
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paparella MM. Current concepts in otitis media. Henry Ford Hosp Med J. 1983;31(1):30-6. No abstract available.
PubMed 6863004Ghaffar S, Ikram M, Zia S, Raza A. Incorporating the endoscope into middle ear surgery. Ear Nose Throat J. 2006 Sep;85(9):593-6.
PubMed 17044426Lima Tde O, Araujo TF, Soares LC, Testa JR. The impact of endoscopy on the treatment of cholesteatomas. Braz J Otorhinolaryngol. 2013 Aug;79(4):505-11. doi: 10.5935/1808-8694.20130090.
PubMed 23929154Badr-El-Dine M, James AL, Panetti G, Marchioni D, Presutti L, Nogueira JF. Instrumentation and technologies in endoscopic ear surgery. Otolaryngol Clin North Am. 2013 Apr;46(2):211-25. doi: 10.1016/j.otc.2012.10.005.
PubMed 23566907Marchioni D, Soloperto D, Rubini A, Villari D, Genovese E, Artioli F, Presutti L. Endoscopic exclusive transcanal approach to the tympanic cavity cholesteatoma in pediatric patients: our experience. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):316-22. doi: 10.1016/j.ijporl.2014.12.008. Epub 2015 Jan 7.
PubMed 25631934
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy
- ClinicalTrials.gov ID
- NCT03294421
- Acronym / sponsor ID
- 50571215.0.0000.5327
- Conditions
- Cholesteatoma, Chronic Otitis Media
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 27 Sep 2017 (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.
Chronic otitis media is a prevalent medical condition, leading to important impact in the lives of the individuals with this condition, and a great amount of patients may need surgical intervention. The main objectives of the surgery in these cases are to restore the anatomy of the middle ear, to improve hearing and to remove the infection to avoid further complications. Still, chronic otitis media with cholesteatoma presents high rates of recurrence and residual symptoms after surgery.
The standard technique used for treatment of chronic otitis media is microsurgery. Nonetheless, with the development of new technologies that use endoscopy, it is now possible to use endoscopic surgery to improve the visualization of the cholesteatoma and ear structures by combining both techniques.
This study will evaluate the efficacy of the combined access surgery technique, which is microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with cholesteatoma. Furthermore, the study aims to compare the results of the combined access technique and the standard technique by randomizing the patients in two groups: one group will receive tympanomastoidectomy by standard technique and the other group will receive combined technique.
Detailed description
Patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be randomized into two groups. In the first group, microsurgical tympanomastoidectomy will be performed; while combined technique will be performed in the other group. The combined technique improves the visualization of the middle ear canal and the mastoid. Herewith, the best visualization of the surgical site facilitates the full removal of the cholesteatoma. In addition to that, the combined technique is less invasive than the standard one, since less bone debridement is required to access the surgical site.
The outcomes of the study will be evaluated through follow up medical appointments and exams. The patients will be followed by monthly medical appointments with otoscopic evaluations for diagnose of possible recurrence of the disease or residual cholesteatoma. Also, audiometry exams will be performed in the third, sixth and twelfth months. Image exams such as nuclear magnetic resonance may be performed at the end of this period to evaluate relapse of the disease if the otoscopic evaluation is inconclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard closed tympanomastoidectomy | Active comparator | Procedure: standard closed tympanomastoidectomyIn this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used. |
| combined access tympanomastoidectomy | Experimental | Procedure: combined access tympanomastoidectomyIn this group a closed tympanomastoidectomy with combined access will be performed. This technique combines the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation. |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cholesteatoma with indication for closed tympanomastoidectomy.
Key exclusion criteria (1 listed)
- Patients with malformation of the temporal bone or previous surgery in the ear eligible for the study.
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 |
|---|---|---|
| combined access tympanomastoidectomyTrans canal surgery with the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation allowing better visualization and removal of the cholesteatoma before mastoid debridement. In this surgery, mastoid debridement is conducted only if there was no full endoscopic removal of the cholesteatoma. The other procedures of this type of surgery are similar to the standard tympanomastoidectomy technique. | Procedure or surgery | combined access tympanomastoidectomy |
| standard closed tympanomastoidectomy1. Supine position and general anesthesia with orotracheal intubation 2. Antisepsis and placing of sterile fields 3. Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI 4. Retroauricular incision 5. Removal of the temporal muscle fascia 6. Elevation of the surgical flap of the tympanic meatus 7. Visualization and exploration of the cholesteatoma 8. Exploration of the ossicular chain 9. Mastoid debridement 10. Conservation of the upper posterior wall of the auditory conduct 11. Removal of the cholesteatoma 12. Tympanoplasty with the temporal fascia 13. Retroauricular suture with vycril 3.0 and mononylon 4.0 | Procedure or surgery | standard closed tympanomastoidectomy |
Primary outcome
Recurrence of cholesteatoma.
Time frame: 12 months post intervention.
Recurrence of cholesteatoma, which is defined as development of new disease in the same ear (not related with the previous cholesteatoma), will be evaluated through second look surgery or nuclear magnetic resonance.
Residual cholesteatoma
Time frame: 12 months post intervention.
Presence of residual cholesteatoma, which is defined as disease that was not fully removed in the first intervention, will be evaluated through second look surgery or nuclear magnetic resonance.
4 secondary outcomes
Hearing outcomes
Time frame: 3 months post intervention.
Hearing outcomes
Time frame: 6 months post intervention.
Hearing outcomes
Time frame: 12 months post intervention.
Length of procedure
Time frame: measured in minutes from the surgical incision until the suture of the skin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 6863004Paparella MM. Current concepts in otitis media. Henry Ford Hosp Med J. 1983;31(1):30-6. No abstract available.
- Background: PubMed 17044426Ghaffar S, Ikram M, Zia S, Raza A. Incorporating the endoscope into middle ear surgery. Ear Nose Throat J. 2006 Sep;85(9):593-6.
- Background: PubMed 23929154Lima Tde O, Araujo TF, Soares LC, Testa JR. The impact of endoscopy on the treatment of cholesteatomas. Braz J Otorhinolaryngol. 2013 Aug;79(4):505-11. doi: 10.5935/1808-8694.20130090.
- Background: PubMed 23566907Badr-El-Dine M, James AL, Panetti G, Marchioni D, Presutti L, Nogueira JF. Instrumentation and technologies in endoscopic ear surgery. Otolaryngol Clin North Am. 2013 Apr;46(2):211-25. doi: 10.1016/j.otc.2012.10.005.
- Background: PubMed 25631934Marchioni D, Soloperto D, Rubini A, Villari D, Genovese E, Artioli F, Presutti L. Endoscopic exclusive transcanal approach to the tympanic cavity cholesteatoma in pediatric patients: our experience. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):316-22. doi: 10.1016/j.ijporl.2014.12.008. Epub 2015 Jan 7.
- Individual participant dataSharing planned: No
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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.
Sady S Da costa principal investigator
Hospital de Clinicas de Porto Alegre
Mauricio LS Da silva principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined access tympanomastoidectomy and standard closed tympanomastoidectomy in people with Cholesteatoma and Chronic Otitis Media, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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 7 Sep 2020. 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of cholesteatoma. (time frame: 12 months post intervention.). The study lists 2 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 NCT03294421, which also lists 5 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 7 Sep 2020.