Treatment of palato-nasal fistula following primary palatoplasty in patients with nonsyndromic cleft palate is often complicated by recurrence. The authors have tested the feasibility of a surgical technique adding a resorbable collagen membrane at the bony edge of the fistula and report the outcome in the first 14 patients in an open, non-comparative, preliminary investigation. The procedure was well tolerated by all patients, with no relapses during follow up ranging from 4 to 12 months.
The incidence of fistula after primary cleft palatoplasty varies between 8 and 30%, depending on the experience of the centre, the severity of the cleft defect (Veau classification), and the type of palatoplasty used for primary closure of the defect . Surgical treatment of fistulas is often complicated by high recurrence rates (up to 33%), further aggravated by multiple scarring surrounding the lesion, with persistent detrimental consequences on speech and velopharyngeal function .
The authors describe, and present the preliminary results of a technique that uses a resorbable collagen membrane as an adjunct to standard surgical care, with the objective of improving the stability of the soft tissue and decreasing the incidence of new dehiscence. The purpose of this preliminary investigation was to investigate the feasibility and tolerability of the new technique.
Materials and methods
The standard surgical technique used in the authors’ unit for fistula management is based on the known technique of multilayer closure. Surgery is performed under general anaesthesia, with a single dose of antibiotic (amoxicillin) given before starting surgery. After injection of local anaesthetic solution containing adrenaline to reduce local bleeding, the fistula is cut down circularly and the fistula’s mucosa is reverted towards the nasal cavity. Similar to the palatoplasty technique, two palatal flaps, one on each side, with pedicles containing the palatal arterial blood supply, are raised while the bony palatal shelves are exposed. This results either in bridge or pedicle flaps ( Fig. 1 ). The bony edges of the palatal bone defect of the fistula are prepared and the covering nasal mucosa is carefully dissected over a few millimetres. The dissected mucosal edges of the fistula can then be sutured towards the nasal cavity and a nasal mucosal layer bridging the defect is created using a resorbable suturing material Vicryl ® 5-0 (Ethicon Co. Norderstedt/Germany) ( Fig. 2 ). If necessary, the two nasal cavities are reconstructed by suturing the reconstructed nasal mucosa with the nasal septum. A resorbable collagen membrane (Geistlich Pharma AG Wolhusen/Switzerland, Geistlich Bio-Gide ® ) is applied over the former fistula to cover the bony defect ( Fig. 3 ). The membrane edges are positioned between the palatal bone and the nasal mucosa in such a way that the membrane is soundly fixed and cannot move. This ensures covering of the defect with a second layer to which a third layer is added by repositioning the two palatal flaps and closing them as in palatoplasty to rebuild the oral mucosa ( Fig. 4 ). A resorbable suturing material is used (Vicryl ® 4-0). Postoperative medication is ibuprofen, according to the pain intensity. Patients are allowed to drink immediately after surgery but soft food is prescribed for a week after the intervention.
All patients were assessed with respect to infection, dehiscence, signs of rejection, and fistula recurrence.
When this manuscript was written, 14 patients had undergone this new operative technique with a minimum follow up of 4 months.
The patients’ data are given in Table 1 , with the duration of follow up and the main outcome of the new technique. Details on primary cleft defect classification, type of primary palatoplasty, fistula size and localization are provided.
|Pat no.||Pat ID||Cleft palate 1||Age (years)||Gender||Palatoplasty (primary closure)||Fistula||FU §||Outcome|
|Size (mm)||Type ∘|
|1||SK||4||2||M||Langenbeck||13 × 4||IV||9||Closed|
|2||KE||3||22||F||Langenbeck||5 × 3||IV||9||Closed|
|3||MS||4||13||F||Furlow||4 × 3||IV||9||Closed|
|4||TT||4||4||M||Langenbeck||12 × 4||IV, V||10||Closed|
|5||GM||2||2||F||Langenbeck||5 × 2||IV||10||Closed|
|6||NK||2||4||M||Langenbeck||9 × 3||IV||12||Closed|
|7||JP||3||13||M||Furlow||11 × 5||IV, V||12||Closed|
|8||MG||4||15||F||Widmair||10 × 3||IV||12||Closed|
|9||MM||2||9||M||Furlow||13 × 6||IV||14||Closed|
|10||KM||3||7||M||Langenbeck||15 × 4||IV||14||Closed|
|11||SM||3||5||M||Furlow||8 × 4||IV, V||14||Closed|
|12||SH||4||5||F||Furlow||9 × 3||IV, V||15||Closed|
|13||EH||3||17||F||Langenbeck||4 × 2||IV||16||Closed|
|14||MU||2||67||M||Langenbeck||15 × 6||IV||16||Closed|