Comparison of tympanoplasty results using gelfoam block support, autologus fat blocks and mix of fat and gelfoam blocks in Chronic Otitis Media: A Clinical Trial studyl

Comparison of tympanoplasty results using gelfoam block support, autologus fat blocks and mix of fat and gelfoam blocks in Chronic Otitis Media

A controlled randomized trial. double-blind with a parallel groupe design of 96 patients(phase 3)

According to the patient group based on randomization, on the graft and in the area of ​​the perforation connection with the graft in groups A, B, and C, respectively, gelfoam, fat, and the combination of gelfoam and fat pressed together are used. The place of operation is Amir al-Momenin Hospital in Rasht city, Gilan province.

Inclusion criteria: patients with chronic otitis media with simple TM perforation and the age range of 18 to 65 years Exclusion criteria: 1. ABG > 40 db 2.Ossicular disorders 3. Evidence of cholesteatoma 4. Complete perforation without edge (at least 2 mm) TM 5. Active otorrhea during the recent a month 6. Presence of large and thick plaques of tympanosclerosis in the edges of perforation 7. underlying diseases such as diabetes, hypothyroidy, severe uremia, bleeding diseases, immunodeficiency diseases, 8. smoking 9. Evidence in favor of Eustachian tube disorder, such as bilateral perforation, bilateral otorrhea, atelectatic ears, etc

Placement of graft by underlay method and middle ear pack in all 3 groups with gelfoam for graft support and then according to the patient group based on randomization, on the graft and in the area of ​​the perforation junction with the graft in Groups A, B, and C, respectively, gelfoam, fat, and the combination of gelfoam and fat are pressed, it is used, and the external ear canal is packed with gelfoam in all 3 groups.

Surgical success rate

The method of random allocation in 3 groups is based on random blocks, the sequence of which will be determined based on Table of random numbers. The list of this sequence of samples in 3 groups will be kept in the ENT research center in a sealed envelope and will be read gradually after the start of the study based on the inclusion criteria of the patients. Then, according to the patient group based on randomization, on the graft and in the area of the perforation connection with the graft, gelfoam is used in group A, and fat block in group B, and the combination of gelfoam and fat block pressed together is used in group C. The external ear canal is packed by Gelfoam in all 3 groups.

The method of random allocation in 3 groups is based on random blocks, the sequence of which will be determined based on Table of random numbers. The list of this sequence of samples in 3 groups will be kept in the ENT research center in a sealed envelope and will be read gradually after the start of the study based on the inclusion criteria of the patients. After collecting the patients according to the random block, the participants are assigned to one of the groups A to c. Patients are not aware of their allocation to treatment groups. Based on the group mentioned in the received envelope, the treating doctor performs one of the treatment measures for the patient. The evaluation of the eardrum transplant result is done one month later by a specialist assistant who The patients are unaware of the therapeutic action taken. The follow-up of the patients is carried out for up to one month by the attending physician who is not aware of the therapeutic action taken.

In the case of individual patients data, all potential data will be shared after de-identifying individuals. The result of the clinical study will be published in the form of an article

The access period starts 6 months after publication of the results.

All researchers

for secondary data analysis and meta-analysis

Dr. shadman nemati, Otorhinolaryngology Research Center. Amiralmomenin Hospital , 17 Shahrivar Street. Bank Melli Square. Rasht.Postal code: 4139638459 -Tell: 01333225242- Mobile: 09111370488- Email: drshadmannemati_ent@yahoo.com

After receiving the applicant's request and a brief statement of the protocol in which the mentioned information is used, a Preliminary review will be done and the information will be sent to the researcher within 2 weeks