With the recent progress in the CLP repair techniques, the procedures to correct cleft lip and palate allow improvisation in outcome and to achieve even better finesse of surgical result [16]. New techniques and modification of previous techniques are developed in recent years to promote the CLP surgery outcomes. Early palatoplasty in patients with UCLP is a new method that needs more studies to evaluate the outcomes of this technique. Current study findings help to increase the knowledge regarding two important complications of this technique including hemorrhagic events and fistula formation.
The results of this study showed that there was no differences in fistula formation as well as hemorrhagic events in patients with UCLP underwent early palatoplasty. There were two patients in both groups with fistula that needs surgical closure; in the case group the fistula repaired in second surgery but in control group patients underwent revision surgery (third surgery) for cleft repair. Fewer revisions mean less scarring and more predictable results in these patients.
Some previous studies were suggested mean age of three months [14, 17], seven months [18], and nine months [15] for single-stage CLP repair [14, 17]. In the current study, palatoplasty was done in early infancy and was in line with Corbo et al. [17] and Laberge et al. [14] studies but all of three reports studied on different outcomes of early palatoplasty. Moreover, different techniques that used for cleft palate closure in these studies were the main difference between studies.
In line with our study, Noor-ul Ferdous et al. [19] found that simultaneous cleft clip and palate is an easy technique without need to blood transfusion. Although there were seven patients with mild bleeding in mentioned study, we had not any perioperative bleeding events among patients. Furthermore, in our study two patients developed to fistula formation but in Noor-ul Ferdous et al. study no patient developed oronasal fistula. Also, fistula repair in second surgery in one of the important factor in operation time duration and in this study lack of fistula in patients is a main cause of lower time in second surgery than first.
A retrospective study by Hodges et al. [20] on patients with UCLP who underwent combined one-stage CLP repair showed that 7 of 106 patients needs surgical closure of fistula and high blood transfusion rate (one-third of patients). In contrast, there was not any severe perioperative bleeding in the current study. Moreover, Hodges et al. study was a “all in one” study but we performed this surgery in two stage that cause less complications, especially bleeding and need for blood transfusion. Also the surgery time is longer in one-stage than two stage method [21].
On the other hand, there are some concerns about speech characteristics after synchronous CLP repair [22]. Luyten et al. [23] reported deviations from normal speech development following this surgery technique before six months of age. Accordingly, speech therapy might be recommended in patients with synchronous CLP repair to reduce speech impairment.
The limited number of patients with UCLP was the main limitation of this study. Also, lack of regular orthodontic care was another limitation that has effective role in reducing postoperative complications such as fistula formation.
This randomized controlled trials study showed that early palatoplasty in patients with UCLP may as safe as conventional method based on hemorrhagic events and fistula formation findings in short time. Trials with large group of patients recommended for evaluation of long term outcomes on this technique.