LIMA Protocol for Palatal Fistula Reduction and Early Postoperative Maxillary Morphology in Unilateral Cleft Lip and Palate: A Randomized Controlled Trial

Abstract

Objective

Compare the incidence of palatal fistula and early postoperative maxillary morphology following cleft palate repair performed using the Lima protocol versus the Two-Flap technique.

Design

This 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.

Setting

A national tertiary referral hospital, January 2022 to December 2024.

Participants

Infants 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.

Interventions

Participants underwent palatoplasty using either the Lima protocol (n = 16) or the Two-Flap technique (n = 19).

Main Outcome Measures

Incidence of palatal fistula and changes in early postoperative maxillary morphology during the first 6 months of follow-up, assessed using dental cast measurements.

Results

A 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).

Conclusion

Both 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.