LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate
NCT ID: NCT07137169
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-01-01
2024-12-31
Brief Summary
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Detailed Description
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Methods: This study is a randomized controlled trial comparing palatoplasty techniques based on the LIMA protocol (Hybrid and one-flap techniques) versus the RSCM protocol (two-flap technique) in terms of surgical outcomes: palatal fistula and maxillary growth. The study was conducted at Cipto Mangunkusumo Hospital (RSCM) from January 2022 to December 2024. Samples were collected consecutively, with all subjects who met the inclusion criteria (patients aged 9 months-2 years with unilateral Veau III-IV cleft palate undergoing primary palatoplasty at RSCM) randomly allocated into two study groups. Data were analyzed using T-test and Mann-Whitney U test.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LIMA Protocol
LIMA Protocol classifies cases of cleft palate based on the cleft severity (using palatal index), and guide which method of cleft palate repair surgery should be done
LIMA protocol
Cleft palate repair using Hybrid / One-flap technique
RSCM Protocol
RSCM Protocol guide which method of cleft palate repair surgery should be done in a cleft palate (without classifying based on cleft palate severity/ palatal index)
RSCM Protocol
Cleft palate repair using Two-flap technique
Interventions
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LIMA protocol
Cleft palate repair using Hybrid / One-flap technique
RSCM Protocol
Cleft palate repair using Two-flap technique
Eligibility Criteria
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Inclusion Criteria
* Patients with complete unilateral cleft lip and palate who underwent palatoplasty surgery at Cipto Mangunkusumo Hospital
Exclusion Criteria
* Patients with complete unilateral cleft lip and palate who have previously undergone cleft palate repair/ palatoplasty
9 Months
24 Months
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Kristaninta Bangun
Principal Investigator, Head of Plastic and Reconstructive Surgery Division
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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Chiu YT, Liao YF. Is cleft severity related to maxillary growth in patients with unilateral cleft lip and palate? Cleft Palate Craniofac J. 2012 Sep;49(5):535-40. doi: 10.1597/10-044. Epub 2010 Dec 23.
Farronato G, Kairyte L, Giannini L, Galbiati G, Maspero C. How various surgical protocols of the unilateral cleft lip and palate influence the facial growth and possible orthodontic problems? Which is the best timing of lip, palate and alveolus repair? literature review. Stomatologija. 2014;16(2):53-60.
Parwaz MA, Sharma RK, Parashar A, Nanda V, Biswas G, Makkar S. Width of cleft palate and postoperative palatal fistula--do they correlate? J Plast Reconstr Aesthet Surg. 2009 Dec;62(12):1559-63. doi: 10.1016/j.bjps.2008.05.048. Epub 2008 Oct 5.
Todorov AB, Bolling DR. A computerized file for studying growth development in achondroplasia. Birth Defects Orig Artic Ser. 1974;10(9):241-4. No abstract available.
Hui BK, Lai LH, Nguyen PD, Yee KS, Martz MG, Bradley JP, et al. Maxillary Hypoplasia in the Cleft Patient: Contribution of Dental Agenesis to Le Fort I Advancement Surgery. Journal of Oral and Maxillofacial Surgery. 2014;72(9):e56-e7.
Smith DM, Vecchione L, Jiang S, Ford M, Deleyiannis FW, Haralam MA, Naran S, Worrall CI, Dudas JR, Afifi AM, Marazita ML, Losee JE. The Pittsburgh Fistula Classification System: a standardized scheme for the description of palatal fistulas. Cleft Palate Craniofac J. 2007 Nov;44(6):590-4. doi: 10.1597/06-204.1.
Rossell-Perry P, Caceres Nano E, Gavino-Gutierrez AM. Association between palatal index and cleft palate repair outcomes in patients with complete unilateral cleft lip and palate. JAMA Facial Plast Surg. 2014 May-Jun;16(3):206-10. doi: 10.1001/jamafacial.2013.2537.
Lima Protocol for Cleft Palate Repair in Cleft and Craniofacial Centre Cipto Mangunkusumo Hospital Indonesia: A Preliminary Study. J Plast Rekons. 2024;9(1):7-12.
Rossell-Perry P, Cotrina-Rabanal O, Figallo-Hudtwalcker O, Gonzalez-Vereau A. Effect of Relaxing Incisions on the Maxillary Growth after Primary Unilateral Cleft Palate Repair in Mild and Moderate Cases: A Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2017 Jan 16;5(1):e1201. doi: 10.1097/GOX.0000000000001201. eCollection 2017 Jan.
Rossell-Perry P, Cotrinal-Rabanal O, Caceres-Nano E. One-flap Palatoplasty: A Cohort Study to Evaluate a Technique for Unilateral Cleft Palate Repair. Plast Reconstr Surg Glob Open. 2015 May 7;3(4):e373. doi: 10.1097/GOX.0000000000000342. eCollection 2015 Apr.
Rossell-Perry P, Luque-Tipula M. The Lima Surgical Protocol for Cleft Palate Repair. J Craniofac Surg. 2020 Sep;31(6):1533-1538. doi: 10.1097/SCS.0000000000006331.
Kreshanti P, Sari VA, Wangge G, Wahyuni LK. Speech Outcome Evaluation Of Cleft Palate Patients Underwent Palatoplasty In Plastic Surgery Division Cipto Mangunkusumo Hospital Indonesia. J Plast Rekonst. 2018;5(1):160-70.
Other Identifiers
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LIMAProtocol
Identifier Type: -
Identifier Source: org_study_id
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