Tympanic Membrane PerforationNCT02331797
Endoscopic Overlay Tympanoplasty for TM Perforation
A study testing Endoscopic Technique and Microscopic Technique in people with Tympanic Membrane Perforation, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Minimally invasive surgery is becoming more common in many surgical fields. The wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Endoscopic Technique and Microscopic Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2014to Oct 2017
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 15-70 years
- The patients who had perforation of tympanic membrane
- The perforations are all dry at the time of surgery and have been dry for at least 3 months.
- No contraindication for local or general anesthesia.
- No recent upper respiratory tract infection at least 2 weeks before surgery.
- No unstable underlying condition.
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- Have at least 2 months of follow up.
- Agree to participate in the study
- Aaccept to be randomized to receive treatment
- Willing to sign an informed consent
Who cannot join
- Medial placing or inlay surgical technique
- Chronic otitis media
- Contraindication of vasoconstriction agent (adrenaline)
- Allergy to analgesic agent (Xylocaine or Lidocaine)
- Concomitant with mastoiditis.
- Previous intracranial or extra-cranial complication of chronic otitis media.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
Minimally invasive surgery is becoming more common in many surgical fields. The wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. The investigators conduct this study to compared post operative pain score (by Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and endoscopic lateral placing tympanoplasty.
Read the detailed description
A main part of tympanoplasty is repair of perforated tympanic membrane. There are two popular way to approach tympanic membrane, transcanal or postauricular approach. There are two grafting techniques are applied in tympanoplasty which includes the lateral technique (overlay) and medial technique (underlay).
The lateral technique is widely used in our institute which involves placement of a graft lateral to the tympanic annulus and the fibrous layer of the tympanic remnant. The most our preferred approach in previous experience is the postauricular approach for tympanoplasty because the transcanal approach is not enough for adequate exposure. Moreover, the visualization straight through transcanal provide by the microscope is difficult by a limited view of the perforation edge due to narrowing and curved external ear canal. Postauricular approach cause many layers of tissue are violated along with a significant postoperative pain.
The author proposed this study with the aim of determining the alleviation of postoperative pain by new technique and the efficacy of endoscope for tympanoplasty.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Endoscopic Technique, Microscopic Technique
- Keywords
- endoscope, microscope, transcanal
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic TechniqueDevice
Endoscopic Technique; endoscopic transcanal lateral graft tympanoplasty using An endoscope (Karl Storz, Tuttlingen, Germany) and A microdrill (Skeeter Otologic Drill System; Medtronic Xom ed Surgical Products, Inc., Jacksonville, FL, USA)
Microscopic TechniqueDevice
Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Technique | Experimental | All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant. Receives: Device: Endoscopic Technique |
| Microscopic Technique | Active comparator | All patients are operated under the microscope.A postauricular or transcanal approach is chose depend on ear canal size and size of perforation. When the ear canal is too small, the postauricular is used. Receives: Device: Microscopic Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score, evaluated by Visual analogue scale.
Evaluate pain score by Visual analogue scale. Patients are asked to score their pain on visual analogue scale at 4 hour, 24 hour and 48 hour postoperative.
Measured: 24 hour postoperative.
Secondary outcomes (3)
Audiometric parameters
Evaluated by audiometry (pure tone average of air and bone conduction, air-bone gap.)
Measured: 20th week postoperative
The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.
The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Measured: 20th week postoperative.
Operative time
The actual operating time is recorded from beginning of local anesthetic injection to the end of the surgery (complete skin suturing).
Measured: Begining to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- 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
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuvatiya Plodpai, Prince of Songkla University
- Investigators
- Yuvatiya Plodpai, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331797
- Sponsor's protocol ID
- REC 57-0123-13-1
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2014
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
- ClinicalTrials.gov ID
- NCT02331797
- Acronym / sponsor ID
- REC 57-0123-13-1
- Conditions
- Tympanic Membrane Perforation
- Keywords
- endoscope, microscope, transcanal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- 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.
Minimally invasive surgery is becoming more common in many surgical fields. The wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. The investigators conduct this study to compared post operative pain score (by Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and endoscopic lateral placing tympanoplasty.
Detailed description
A main part of tympanoplasty is repair of perforated tympanic membrane. There are two popular way to approach tympanic membrane, transcanal or postauricular approach. There are two grafting techniques are applied in tympanoplasty which includes the lateral technique (overlay) and medial technique (underlay).
The lateral technique is widely used in our institute which involves placement of a graft lateral to the tympanic annulus and the fibrous layer of the tympanic remnant. The most our preferred approach in previous experience is the postauricular approach for tympanoplasty because the transcanal approach is not enough for adequate exposure. Moreover, the visualization straight through transcanal provide by the microscope is difficult by a limited view of the perforation edge due to narrowing and curved external ear canal. Postauricular approach cause many layers of tissue are violated along with a significant postoperative pain.
The author proposed this study with the aim of determining the alleviation of postoperative pain by new technique and the efficacy of endoscope for tympanoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Technique | Experimental | Device: Endoscopic TechniqueAll patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant. |
| Microscopic Technique | Active comparator | Device: Microscopic TechniqueAll patients are operated under the microscope.A postauricular or transcanal approach is chose depend on ear canal size and size of perforation. When the ear canal is too small, the postauricular is used. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 15-70 years
- The patients who had perforation of tympanic membrane
- The perforations are all dry at the time of surgery and have been dry for at least 3 months.
- No contraindication for local or general anesthesia.
- No recent upper respiratory tract infection at least 2 weeks before surgery.
Key exclusion criteria (7 listed)
- Medial placing or inlay surgical technique
- Chronic otitis media
- Contraindication of vasoconstriction agent (adrenaline)
- Allergy to analgesic agent (Xylocaine or Lidocaine)
- Concomitant with mastoiditis.
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 |
|---|---|---|
| Endoscopic TechniqueEndoscopic Technique; endoscopic transcanal lateral graft tympanoplasty using An endoscope (Karl Storz, Tuttlingen, Germany) and A microdrill (Skeeter Otologic Drill System; Medtronic Xom ed Surgical Products, Inc., Jacksonville, FL, USA) | Device | Endoscopic Technique |
| Microscopic TechniqueMicrosopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope | Device | Microscopic Technique |
Primary outcome
Postoperative pain score, evaluated by Visual analogue scale.
Time frame: 24 hour postoperative.
Evaluate pain score by Visual analogue scale. Patients are asked to score their pain on visual analogue scale at 4 hour, 24 hour and 48 hour postoperative.
3 secondary outcomes
Audiometric parameters
Time frame: 20th week postoperative
The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Time frame: 20th week postoperative.
Operative time
Time frame: Begining to the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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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.
Yuvatiya Plodpai, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Technique and Microscopic Technique in people with Tympanic Membrane Perforation, run by Prince of Songkla University at 1 site in Thailand.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 19 Dec 2017. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain score, evaluated by Visual analogue scale. (time frame: 24 hour postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.