LIMA Protocol for Palatal Fistula Reduction and Early Postoperative Maxillary Morphology in Unilateral Cleft Lip and...

ObjectiveCompare the incidence of palatal fistula and early postoperative maxillary morphology following cleft palate repair performed using the Lima protocol versus the Two-Flap technique.DesignThis is a double-blind randomized controlled trial. Participants were randomly allocated to treatment groups using a random table. All surgeries were performed by a single surgeon at a single center.SettingA national tertiary referral hospital, January 2022 to December 2024.ParticipantsInfants aged 9 months to 2 years with unilateral cleft lip and palate who had not previously undergone palatal repair. Those with a history of prior palatal surgery or refusal to participate were excluded.InterventionsParticipants underwent palatoplasty using either the Lima protocol (n = 16) or the Two-Flap technique (n = 19).Main Outcome MeasuresIncidence of palatal fistula and changes in early postoperative maxillary morphology during the first 6 months of follow-up, assessed using dental cast measurements.ResultsA total of 39 patients were enrolled, with 35 completing follow-up. Baseline characteristics were comparable between groups. Postoperative palatal fistula occurred in 11% of patients, with no significant difference between the Lima and Two-Flap groups. Early postoperative maxillary morphology parameters showed similar trajectories across groups, except for greater inter-canine width in the Lima group at 6 months (P = .017) and greater palatal length increase in the Two-Flap group between 1 and 6 months post-op (P = .018).ConclusionBoth the Lima and Two-Flap techniques demonstrated comparable efficacy in preventing fistula and preserving early postoperative maxillary morphology. These findings represent short-term outcomes, and longer follow-up is required to evaluate long-term maxillary growth.