Purpose: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the surgical outcomes of type-1 tympanoplasty with and without gelfoam middle ear packing.
Methods: PubMed, CENTRAL, Scopus, Web of Science, and Google Scholar databases were screened from inception until October 2022. The included RCTs were evaluated for risk of bias, and the quality of each outcome was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.
Results: Nine RCTs with 773 participants (gelfoam = 381 and non-gelfoam = 392) were analyzed. The overall study quality varied: low risk (n = 4 RCTs), some concerns (n = 3 RCTs), and high risk (n = 2 RCTs). There were no significant differences between both arms regarding the graft uptake rate (moderate certainty), hearing improvement rate (moderate certainty), type of impedance audiometry (moderate certainty), and ear discharge (low certainty). The mean change in air-bone gap was significantly higher in the non-gelfoam arm compared with the gelfoam arm (low certainty). However, the non-gelfoam group had superior hearing improvement in only the early postoperative period (i.e., one month); however, after two, three, and six months, there were no significant differences between both arms. The rate of ear fullness was significantly higher in the gelfoam arm compared with the non-gelfoam arm (moderate certainty).
Conclusion: Among patients undergoing type-1 tympanoplasty, the surgical outcomes did not significantly differ between both arms. The practice of middle ear packing with gelfoam needs to be standardized.
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