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IRCT20191123045472N1 IRCT 2020-07-13 Tehran University of Medical Sciences Comparison of CWD and ICW tympanomastoidectomy with endoscopic control to evaluate residual cholesteatoma for patients with middle and mastoid cholesteatoma Comparison of residual cholesteatoma in two methods of tympanomastoidectomy CWD and ICW with endoscopic control in patients with middle ear and mastoid cholesteatoma 2011-04-04 anticipated 40 Complete https://irct.ir/trial/43763 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization type is blocked randomization. Foursquare blocks of intervention group(A) and control(B) are defined on cards 1-6 (AABB,ABAB,ABBA,BBAA,BABA,BAAB), the cards are placed inside the envelope. Then the cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence, Blinding description: The study is single-blind. In the informed consent, it is mentioned that the patients will be treated randomly in one of two methods (both are the standard method and the same postoperative appearance), so patients are unaware of which group they are involved in. 3 Tympanomastoidectomy in people with cholesteatoma. Intervention 1: "Intervention group": Twenty patients with cholesteatoma in the intervention group underwent CWD (tympanomastoidectomy with posterior wall resection) without chain reconstruction. Posterior wall resection (CWD) is a standard surgical treatment for cholesteatoma, but it has many complications. After surgery, patients were examined microscopically at 3, 6, 9, and 12 months, and then at the 12th month, patients with local anesthesia and sedation underwent middle ear surgery and, if possible, chain reconstruction. Midterm surgery was performed to check for pearl and residual cholesteatoma using a 30 ° and 2.7 mm endoscope, and recurrence rate was recorded. Mann-Whitney and Fisher's exact tests were used for data analysis. Intervention 2: "Control group:" In the control group, twenty patients with surgical candidate cholesteatoma underwent endoscopic ICW (tympanomastoidectomy with posterior wall preservation). This procedure has fewer complications, but access to middle ear rosettes is more difficult than CWD. In this study, an endoscope was used to access ear rosettes that are not accessible by microscope.After surgery, patients were examined microscopically at 3, 6, 9, and 12 months, and then at the 12th month, patients with local anesthesia and sedation underwent middle ear surgery and, if possible, chain reconstruction. Midterm surgery was performed to check for pearl and residual cholesteatoma using a 30 ° and 2.7 mm endoscope, and recurrence rate was recorded. Mann-Whitney and Fisher's exact tests were used for data analysis. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no data available yet.
public Dr. Pedram Borghei
AmirAlam hospital, North Saadi Ave
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6634 9253 entrc.tums@gmail.com Tehran University of Medical Sciences scientific Dr.Pedram Borghei
AmirAlam hospital , North Saadi Ave
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6634 9253 entrc.tums@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who were diagnosed with microscopic examination of cholesteatoma and who were candidates for surgery, with any hearing loss no limit no limit Both Patient with cholesteatoma with posterior wall destruction The patient does not follow-up or postoperative follow-up examinations for any reason. The patient has complications of cholesteatoma, such as dizziness, facial paralysis, sensorineural hearing loss average or above average, intracranial complications, mastoid abscess, lateral sinus thrombosis, etc The patient should be treated with revision Failure after graft surgery H71 Cholesteatoma of middle ear Treatment - Surgery Treatment - Surgery "Intervention group": Twenty patients with cholesteatoma in the intervention group underwent CWD (tympanomastoidectomy with posterior wall resection) without chain reconstruction. Posterior wall resection (CWD) is a standard surgical treatment for cholesteatoma, but it has many complications. After surgery, patients were examined microscopically at 3, 6, 9, and 12 months, and then at the 12th month, patients with local anesthesia and sedation underwent middle ear surgery and, if possible, chain reconstruction. Midterm surgery was performed to check for pearl and residual cholesteatoma using a 30 ° and 2.7 mm endoscope, and recurrence rate was recorded. Mann-Whitney and Fisher's exact tests were used for data analysis. "Control group:" In the control group, twenty patients with surgical candidate cholesteatoma underwent endoscopic ICW (tympanomastoidectomy with posterior wall preservation). This procedure has fewer complications, but access to middle ear rosettes is more difficult than CWD. In this study, an endoscope was used to access ear rosettes that are not accessible by microscope.After surgery, patients were examined microscopically at 3, 6, 9, and 12 months, and then at the 12th month, patients with local anesthesia and sedation underwent middle ear surgery and, if possible, chain reconstruction. Midterm surgery was performed to check for pearl and residual cholesteatoma using a 30 ° and 2.7 mm endoscope, and recurrence rate was recorded. Mann-Whitney and Fisher's exact tests were used for data analysis. The amount of remaining cholesteatoma. Timepoint: 3 months, 6 months, 9 months and 12 months. Method of measurement: Endoscope 30 ° and 7.2 mm. Tehran University of Medical Sciences Approved 2006-06-18 Ethics committee of Tehran University of Medical Sciences Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods St,Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)