Using Reverse Flow Based Flap VS Palatal Pedicled Flap for Closure of Recurrent Small & Medium Sized Oronasal Fistula.

NCT04814901 | Completed

• 1 other identifier: OMFS 3-3-8
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Research question: What are the outcomes of using the Facial artery Musculomucosal (FAMM) Flap to close recurrent small and medium sized oronasal fistulae based on reverse flow on patient's satisfaction versus using the Palatal Pedicled flap? Statement of the problem: To determine whether the using the Facial artery Musculomucosal (FAMM) Flap to close recurrent small and medium sized oronasal fistulae which are difficult to manage could meet the patients satisfaction regarding both success and function versus using palatal pedicled flap

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• questionnaire

  Meet the patients satisfaction regarding both success and function after closure of recurrent small and medium sized oronasal fistula using the Facial artery Musculomucosal (FAMM) Flap

  3 months

Study Arms (2)

Study group

EXPERIMENTAL

Surgical closure of patients with recurrent small to medium sized oronasal fistulae using FAMM and assessment of success regarding patient satisfaction and healing and absence of complications such as venous congestion, dehiscence, facial nerve injury and infection.

Procedure: Curing small and medium sized oronasal fistula

Comparator group

ACTIVE COMPARATOR

Surgical closure of patients with recurrent small to medium sized oronasal fistulae and its effect on patient's satisfaction and healing and absence of complications such as venous congestion, dehiscence, facial nerve injury and infection

Procedure: Curing small and medium sized oronasal fistula

Interventions

Curing small and medium sized oronasal fistula PROCEDURE

* Flap will be marked medial to the duct, which limits posterior extent of flap. Anterior flap marking starts 1cm posterior to oral commissure. * Width of flap was kept to about 2-2.5cm. * An initial incision will be made 1cm posterior to oral commissure. * Incision will be deepened through buccal mucosa, submucosa, \& underlying muscles into layer of buccal fat. * Flap will be dissected in a retrograde or antegrade manner depending on fistula site, maintaining vessels in a central position in the flap. * Once completely raised, flap inserted \& sutured in place while donor site be closed primarily with 4-0 polyglactin (Vicryl) interrupted sutures. * Patient's comparator group will be treated by raising a palatal pedicled flap. * Flap will be outlined extending from palatal mucosa against permanent 2nd molar till permanent canine anteriorly. * It is rotated towards oronasal fistula \& secured in place using 4 -0 Vicryl interrupted sutures.

Comparator group; Study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with recurrent small and medium sized oronasal fistula failed after several attempts closure, up to 10 mm regardless of number of recurrence and position of the fistula.
• Age group : from 18 to 60 years old.
• No sex predilection.
• Patients with no contraindications to surgical intervention.
• Patients accepting consent for extracting one teeth in the surgical field if needed.
• Patients proved with Doppler study with a patent facial artery course.

You may not qualify if:

• Patients with systemic condition counteracting with the surgical procedure.
• Patients who underwent a previously ipsilateral cheek flap except for midline fistulae.

Sponsors & Collaborators

• Doaa Jawad Roomi: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11553, Egypt

Location

Related Publications (18)

• 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

• Xiong B, Zhao M, Cheng T, Gao P. [Analysis of 5459 cleft lip and palate cases]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2002 Sep;18(5):294-6. Chinese.

  PMID: 12471822 BACKGROUND

• Wang HT, Li F. [Clinical study on fistula incidence of early cleft palate repair]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2003 May;19(3):192-4. Chinese.

  PMID: 12958822 BACKGROUND

• Richardson S, Agni NA. Palatal fistulae: a comprehensive classification and difficulty index. J Maxillofac Oral Surg. 2014 Sep;13(3):305-9. doi: 10.1007/s12663-013-0535-2. Epub 2013 May 26.

  PMID: 25018605 BACKGROUND

• Cohen SR, Kalinowski J, LaRossa D, Randall P. Cleft palate fistulas: a multivariate statistical analysis of prevalence, etiology, and surgical management. Plast Reconstr Surg. 1991 Jun;87(6):1041-7.

  PMID: 2034725 BACKGROUND

• Dupoirieux L, Plane L, Gard C, Penneau M. Anatomical basis and results of the facial artery musculomucosal flap for oral reconstruction. Br J Oral Maxillofac Surg. 1999 Feb;37(1):25-8. doi: 10.1054/bjom.1998.0301.

  PMID: 10203218 BACKGROUND

• Jackson IT. Closure of secondary palatal fistulae with intra-oral tissue and bone grafting. Br J Plast Surg. 1972 Apr;25(2):93-105. doi: 10.1016/s0007-1226(72)80028-6. No abstract available.

  PMID: 4554003 BACKGROUND

• Rayner CR. Oral mucosal flaps in midfacial reconstruction. Br J Plast Surg. 1984 Jan;37(1):43-7. doi: 10.1016/0007-1226(84)90039-0.

  PMID: 6692059 BACKGROUND

• Sasaki TM, Taylor L, Martin L, Baker HW, McConnell DB, Vetto RM. Correction of cervical esophageal stricture using an axial island cheek flap. Head Neck Surg. 1983 Sep-Oct;6(1):596-9. doi: 10.1002/hed.2890060110.

  PMID: 6629796 BACKGROUND

• Bozola AR, Gasques JA, Carriquiry CE, Cardoso de Oliveira M. The buccinator musculomucosal flap: anatomic study and clinical application. Plast Reconstr Surg. 1989 Aug;84(2):250-7. doi: 10.1097/00006534-198908000-00010.

  PMID: 2748738 BACKGROUND

• Pribaz J, Stephens W, Crespo L, Gifford G. A new intraoral flap: facial artery musculomucosal (FAMM) flap. Plast Reconstr Surg. 1992 Sep;90(3):421-9. doi: 10.1097/00006534-199209000-00009.

  PMID: 1513887 BACKGROUND

• Ariffuddin I, Arman Zaharil MS, Wan Azman WS, Ahmad Sukari H. The use of facial artery musculomucosal (FAMM) readvancement flap in closure of recurrent oronasal fistula. Med J Malaysia. 2018 Apr;73(2):112-113.

  PMID: 29703876 BACKGROUND

• Yilmaz T, Suslu AE, Gursel B. Treatment of oroantral fistula:experience with 27 cases. Am J Otolaryngol. 2003 Jul-Aug;24(4):221-3. doi: 10.1016/s0196-0709(03)00027-9.

  PMID: 12884211 BACKGROUND

• Shetty R, Lamba S, Gupta AK. Role of facial artery musculomucosal flap in large and recurrent palatal fistulae. Cleft Palate Craniofac J. 2013 Nov;50(6):730-3. doi: 10.1597/12-115. Epub 2013 Feb 18.

  PMID: 23418920 BACKGROUND

• Ashtiani AK, Emami SA, Rasti M. Closure of complicated palatal fistula with facial artery musculomucosal flap. Plast Reconstr Surg. 2005 Aug;116(2):381-6; discussion 387-8. doi: 10.1097/01.prs.0000142475.63276.87.

  PMID: 16079659 BACKGROUND

• Sohail M, Bashir MM, Khan FA, Ashraf N. Comparison of Clinical Outcome of Facial Artery Myomucosal Flap and Tongue Flap for Closure of Large Anterior Palatal Fistulas. J Craniofac Surg. 2016 Sep;27(6):1465-8. doi: 10.1097/SCS.0000000000002773.

  PMID: 27526234 BACKGROUND

• Lahiri A, Richard B. Superiorly based facial artery musculomucosal flap for large anterior palatal fistulae in clefts. Cleft Palate Craniofac J. 2007 Sep;44(5):523-7. doi: 10.1597/06-164.1.

  PMID: 17760492 BACKGROUND

• Rauso R, Tartaro G, Califano L, Rugge L, Chirico F, Colella G. Pedicled palatal flap for surgical repair of oro-nasal fistula. J Biol Regul Homeost Agents. 2018 Nov-Dec;32(6):1565-1567.

  PMID: 30574765 BACKGROUND

Related Links

• Myomucosal island flap of the buccinator Muscle: An anatomical study

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 arms parallel group of patients will be assigned to this trial: The trial will be in superiority in an allocation of 1:1 ratio.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 24, 2021
• Study Start: December 3, 2020
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)