Comparison of residual cholesteatoma in two methods of tympanomastoidectomy CWD and ICW with endoscopic control in patients with middle ear and mastoid cholesteatoma

The purpose of this study was to compare residual cholesteatoma in two methods of tympanomastoidectomy CWD and ICW with endoscopic control in patients with middle ear and mastoid cholesteatoma.

A concealed, randomized, blinded, sham-controlled clinical trial with a parallel-group design of 40 patients, enrolled between April 2011 and April 2015 and followed for four years.

In a randomized clinical trial, 40 patients referred to Amir Al Hospital with middle ear cholesteatoma selected for tympanomastoidectomy were enrolled. They then underwent either endoscopic ICW or CWD without the need for chain reconstruction. After surgery, the patients were microscopically examined at 3, 6, 9 and 12 months, in the 12th month, patients with local anesthesia and sedation underwent middle ear revision surgery and, if possible,chain reconstruction. Mid-ear surgery for pearl and residual cholesteatoma was checked using a 30 ° and 2.7 mm endoscope and relapse data was recorded.

inclusion criteria : Patients diagnosed with microscopic examination of the cholesteatoma and who were candidates for surgery were enrolled with any degree of hearing. Exclusion criteria: 1) Cholesteatoma associated with posterior wall destruction 2) The patient does not seek follow-up or postoperative follow-up examination for any reason. 3) the patient has complications of cholesteatoma, such as dizziness, facial palsy, moderate to high sensory neuronal hearing loss and above Moderate, intracranial complications, mastoid abscess, lateral sinus thrombosis, etc. 4) Failure after graft surgery 5) The patient should be treated

Comparison of residual cholesteatoma in subjects with middle ear and mastoid cholesteatoma

The ICW method is comparable to the endoscopic control of the CWD method, with much fewer complications.

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.

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.