LIMA Protocol Towards Palatal Fistula and Maxillary Growth in Cleft Palate

NCT07137169 | Completed

• 1 other identifier: LIMAProtocol
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial compared palatoplasty outcomes using the LIMA protocol (Hybrid and one-flap techniques) versus the RSCM protocol (two-flap technique) in patients with unilateral Veau III-IV cleft palate at Cipto Mangunkusumo Hospital from January 2022 to December 2024.

Conditions

Cleft Palate; Fistula of Soft Palate (Disorder); Maxillar Hypoplasia

Keywords

LIMA Protocol; cleft palate; palatoplasty; cleft palate repair; palatal fistula; maxillary growth restriction

Outcome Measures

Primary Outcomes (2)

• Maxillary Size Indicators Observed From Dental Casts

  Maxillary growth is assessed by measuring its size based on indicators obtained from dental casts before surgery, 1 month post-surgery, and 6 months post-surgery. There will be 4 indicators, namely: 1. 'CC = primary inter-canine width 2. 'TT = inter-tuberosity width 3. 'ICC = length from incisivus to the 'CC line (indicating anterior palatal length) 4. 'ITT = length from incisivus to the 'TT line (indicating overall palatal length)

  From the time of surgery until 6 months post-operatively

• Palatal Fistula by Pittsburgh Classification

  A palatal fistula is an abnormal opening in the palate that persists or develops after cleft palate repair, creating a connection between the oral and nasal cavities, excluding openings due to wound/ suture dehiscence. The location of opening will be Classified using Pittsburgh Classification; Type I: uvula; Type II: soft palate; Type III: junction between the soft and hard palate; Type IV: hard palate; Type V: junction between the primary and secondary palate; Type VI: lingual-alveolar; Type VII: labial-alveolar.

  From the time of surgery until 6 months post-operatively

Study Arms (2)

LIMA Protocol

EXPERIMENTAL

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

Procedure: LIMA protocol

RSCM Protocol

ACTIVE COMPARATOR

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)

Procedure: RSCM Protocol

Interventions

LIMA protocol PROCEDURE

Cleft palate repair using Hybrid / One-flap technique

LIMA Protocol

RSCM Protocol PROCEDURE

Cleft palate repair using Two-flap technique

RSCM Protocol

Eligibility Criteria

• Age: 9 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with complete unilateral cleft lip and palate aged 9 months to 2 years who agreed to be research subjects
• Patients with complete unilateral cleft lip and palate who underwent palatoplasty surgery at Cipto Mangunkusumo Hospital

You may not qualify if:

• Patients who refuse to be research subjects and do not want to sign consent form
• Patients with complete unilateral cleft lip and palate who have previously undergone cleft palate repair/ palatoplasty

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (12)

• 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.

  PMID: 21214323 BACKGROUND

• 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.

  PMID: 25209227 BACKGROUND

• 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.

  PMID: 18838320 BACKGROUND

• 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.

  PMID: 4422204 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18177198 BACKGROUND

• 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.

  PMID: 24652124 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28203502 BACKGROUND

• 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.

  PMID: 25973351 BACKGROUND

• 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.

  PMID: 32195838 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Retrognathia

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mandibular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Plastic and Reconstructive Surgery Division

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 22, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)