LIMA Protocol for Palatal Fistula Reduction and Early Postoperative Maxillary Morphology in Unilateral Cleft Lip and Palate: A Randomized Controlled Trial.
Kristaninta Bangun, Alberta Jesslyn Gunardi, Vika Tania et al.
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In 30 seconds
This double-blind randomized controlled trial compared the Lima protocol with the Two-Flap technique for primary palatoplasty in infants aged 9 months to 2 years with unilateral cleft lip and palate. Of 39 enrolled participants, 35 completed follow-up. Palatal fistula occurred in 11% overall, with no significant difference between groups. Dental-cast measurements over 6 months showed broadly similar early maxillary morphology, although inter-canine width was greater in the Lima group at 6 months and palatal length increased more in the Two-Flap group between 1 and 6 months.
Key findings
- Palatal fistula occurred in 11% of patients, with no significant difference between the Lima and Two-Flap groups.
- At 6 months, inter-canine width was greater in the Lima group (P = .017).
- Palatal length increased more in the Two-Flap group between 1 and 6 months postoperatively (P = .018).
Why it matters
The trial provides a randomized comparison of two palatoplasty approaches for fistula occurrence and early maxillary morphology. The similar overall outcomes suggest neither technique showed a clear short-term advantage on these measures, while the differences in selected dental-cast measurements warrant interpretation alongside longer-term growth outcomes.
What to keep in mind
Follow-up was limited to 6 months, so long-term maxillary growth could not be assessed. The study was conducted at a single center, with all surgeries performed by one surgeon.