Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy
|ClinicalTrials.gov Identifier: NCT03294421|
Recruitment Status : Unknown
Verified April 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholesteatoma Chronic Otitis Media||Procedure: combined access tympanomastoidectomy Procedure: standard closed tympanomastoidectomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy|
|Actual Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||August 31, 2019|
Active Comparator: standard closed tympanomastoidectomy
In this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used.
Procedure: standard closed tympanomastoidectomy
Experimental: combined access tympanomastoidectomy
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.
Procedure: combined access tympanomastoidectomy
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.
- 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.
- Hearing outcomes [ Time Frame: 3 months post intervention. ]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.
- Hearing outcomes [ Time Frame: 6 months post intervention. ]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.
- Hearing outcomes [ Time Frame: 12 months post intervention. ]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.
- Length of procedure [ Time Frame: measured in minutes from the surgical incision until the suture of the skin. ]Compares the length of the closed tympanomastoidectomy with standard technique and the combined access tympanomastoidectomy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294421
|Contact: Sady S Da costa||555133376090 ext firstname.lastname@example.org|
|Contact: Mauricio LS Da email@example.com|
|Principal Investigator:||Sady S Da costa||Hospital de clínicas de Porto Alegre|
|Principal Investigator:||Mauricio LS Da silva||Hospital de clínicas de Porto Alegre|