DESIGN
This review protocol has been registered in the International Prospective Register of Systematic Reviews (PROSPERO) (ID CRD42021221115).
Search strategy
A systematic review was conducted between November 1 and December 31, 2020, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines13. We conducted systematic electronic searches for studies in the English, Italian, German, French or Spanish language reporting original data obtained from humans focused on the role of adenoidectomy in the treatment of middle ear disease in the cleft (lip and) palate population, with no publication date restrictions.
On November 18th, 2020, we searched the MEDLINE, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases with the following extremely wide search string (common to all databases):
(”adenoidectomy” OR ”adenotonsillectomy”) AND ”cleft”
We focused on studies on CP±L children, diagnosed with OME, RAOM, and/or ORCHL, undergoing adenoidectomy or adenotonsillectomy. As per study design, we included only studies where the patients were diagnosed with a) OME, defined with tympanometry or otoscopy; b) ORCHL, quantified with pure tone audiometry; or c) RAOM. Similarly, another inclusion criterion for studies was reporting respective outcomes as a) resolution of OME, defined with normal tympanometry or otoscopy; b) improvement of ORCHL, quantified with pure tone audiometry; or c) reduction of acute otitis media episodes.
We excluded meta-analyses, systematic and narrative reviews, and case reports. There was no minimum study population size required. References from reviews and included articles were nevertheless checked for additional potentially relevant studies.
Abstracts and full texts were reviewed in duplicate (XX and XX, blinded for review purposes). All disagreements were resolved by evaluation from a third rater (XX, blinded for review purposes).