Cleft Palate Repair Postoperative Management: Current Practices in the United States

Abstract

Objective:

To describe current postoperative management practices following cleft palate repair.

Design:

A survey was administered to cleft surgeons to collect information on their demographic characteristics, surgical training, surgical practice, and postoperative management preferences.

Setting:

Eighteen tertiary referral hospitals across the United States.

Participants:

Surgeons (n=67) performing primary cleft palate repair.

Results:

Postoperative diet restrictions were imposed by 92% of surgeons; pureed foods were allowed at one week after surgery by 90% of surgeons; a regular diet was allowed at one month by 80% of surgeons. Elbow immobilizers and/or mittens were used by 85% of surgeons, for a median duration of two weeks. There was significant disagreement about postoperative use of bottles (61% allow), sippy cups (68% allow), pacifiers (29% allow), and antibiotics (45% prescribe). Surgeon specialty was not associated with any aspect of postoperative management (p>0.05 for all comparisons). Surgeon years in practice, a measure of surgeon experience, was associated only with sippy cup use (p<0.01). The hospital at which the surgeon practiced was associated with diet restrictions (p<0.01), bottle use (p<0.01), and use of elbow immobilizers or mittens (p<0.01); however, many hospitals still had disagreement among their surgeons.

Conclusions:

Surgeons broadly agree on diet restrictions and the use of elbow immobilizers or mittens following palate repair. Almost all other aspects of postoperative management, including the type and duration of diet restriction as well as the duration of immobilizer use, are highly individualized.

Introduction

Although most cleft surgeons in the United States agree that cleft palate repair should be performed by 18 months of age,^1,2 there remains variation in many other aspects of cleft palate repair.³ Surgical technique is perhaps the most heavily debated topic, but there is also variation among surgeons and cleft teams with respect to several aspects of postoperative management.⁴

Postoperative management practices are of great concern to both caregivers and practitioners, as they generally restrict feeding and mobility at a time when surgery has made the child uncomfortable and the caregivers anxious.^5,6 Postoperative dietary restrictions are intended to optimize wound healing and decrease fistula incidence, but they also limit food choices and disrupt children’s feeding behaviors.^7,8 Restrictions regarding bottles, cups, and pacifiers likewise require tradeoffs between reducing trauma to the surgical site and disrupting children’s established feeding regimen.^9,10 Finally, many centers use elbow immobilizers or mittens to minimize the chance for trauma to the surgical site, but these limit a child’s ability to play and self-soothe.^10,11 Given the interest among caregivers and providers in postoperative feeding and other restrictions, comparing practices among cleft surgeons could provide evidence about which postoperative management guidelines surgeons believe to be safe and effective.^3,12

The authors are currently conducting a prospective, observational study comparing the palate repair techniques of straight-line repair with intravelar veloplasty and Furlow double-opposing Z-plasty. This study, which has recruited over 1000 children from eighteen centers in the United States, has collected detailed information on pre-, intra-, and postoperative care. Here, we draw on surveys completed by the surgeons at each hospital that detail their individual approach to post-palatoplasty management. Our purpose is to characterize postoperative management preferences among surgeons and examine how these preferences may be influenced by type of surgical training, years in practice, and hospital affiliation.

Methods

As part of an ongoing prospective, observational study comparing the palate repair techniques of straight-line repair with intravelar veloplasty to Furlow double-opposing Z-plasty, cleft surgeons at eighteen hospitals across the United States provided information on their demographic characteristics, surgical training, surgical practice, and postoperative management preferences. This information was collected using standardized data collection forms (available upon request) collected at the time of surgeon recruitment to the study. This study was approved by The University of Utah Institutional Review Board, protocol #00105205. Written informed consent was obtained from all surgeons.

Statistical Analysis

Descriptive statistics were used to evaluate surgeon characteristics. Median and range were reported. To test for differences between groups, Kruskal-Wallis test was used for continuous variables and Fisher exact test for categorical variables. Pearson correlation coefficients were used to explore relationships between continuous variables. Statistical analyses were performed using Stata version 14.2. Statistical significance was set at p<0.01.

Results

Provider Demographics

A total of 67 surgeons completed the survey, the majority of whom were male (n = 46, 69%) and white (n=50, 75%) (Table 1). Most surgeons were board certified/board eligible in either plastic surgery (n=51, 76%) or otolaryngology (n=10, 15%), with one oral and maxillofacial surgeon and three surgeons having multiple certifications. Surgeons had been in practice for a median of 11 years (range = 0 to 41 years). Most surgeons completed fellowships in either craniofacial/pediatric plastic surgery (n = 50, 77%) or pediatric otolaryngology (n = 9, 14%) (Table 1).

Table 1.

Characteristics of surgeons performing palate repair.

Characteristic	n (%)
Total	67
Gender
Female	21 (31)
Male	46 (69)
Race
White	50 (75)
Asian	12 (18)
Black or African American	01 0(1)
More than one race	03 0(4)
Unknown or Not Reported	01 0(1)
Ethnicity
Hispanic or Latino	01 0(1)
Not Hispanic or Latino	66 (99)
Specialty
Plastic Surgery	51 (76)
Otolaryngology	10 (15)
Facial Plastic Surgery	01 0(1)
Oral & Maxillofacial Surgery	01 0(1)
Multiple Certifications	03 0(4)
Years in Practice
Median (IQR)	11 (4,21)
Range	0 – 41
Fellowship Training
Craniofacial and/or Pediatric Plastic Surgery	50 (75)
Pediatric Otolaryngology	09 (13)
Facial Plastic Surgery	01 0(1)
Oral-Maxillofacial/Craniofacial Surgery	00 0(0)
Multiple: Craniofacial/Pediatric & Facial Plastic Surgery	01 0(1)
Multiple: Craniofacial/Pediatric & Oral-Maxillofacial/Craniofacial Surgery	02 0(3)
None	02 0(3)

Postoperative Diet Restrictions

Ninety-two percent of surgeons (n=62) imposed some form of postoperative diet restriction immediately following surgery. The type and duration of these restrictions varied among surgeons, as shown in Figure 1.

Figure 1.

Surgeon Preference for Diet Restrictions After Palate Repair. The proportion of surgeons that allowed for clear, full liquid, pureed, soft, or unrestricted food consumption across post-operative days indicate that, while almost all surgeons imposed some form of food restriction, the types and duration of such restrictions varied greatly by surgeon.

Surgeons allowed a full liquid diet after a median of zero days (range, 0 – 2 days), a pureed diet (e.g., stage 1 and 2 baby foods) after a median of one day (range, 0 – 42 days), a soft diet after a median of seven days (range, 0 – 42 days), and an unrestricted diet after a median of 21.0 days (range, 0 – 45 days) (Figure 1).

There were no significant differences among surgical specialties in the duration of diet restrictions (p=0.37) or when diets were advanced to less restrictive consistencies (p>0.3). There was a tendency for surgeons with more years in practice to advance to an unrestricted diet earlier (r=0.34, 95% CI 0.10–0.54).

There were significant differences among hospitals regarding when diets were advanced. The median time when patients were advanced to a pureed diet ranged from 0 to 42 days across hospitals (p<0.001), where the median time when patients were advanced to a soft diet ranged from 0 to 42 days across hospitals (p<0.001). Additionally, and the median time of patient advancement to a regular, unrestricted diet ranged from 10 to 42 days across hospitals (p<0.001).

Of the 18 participating hospitals, only two hospitals (11%) had consistent diet restrictions across all of their surgeons.

Postoperative Instructions

Postoperatively, 39% percent of surgeons did not allow children to use a bottle immediately after surgery (Figure 2A). There was no significant difference in restriction of bottle use among surgical specialties (p=0.89) or surgeon years in practice (p=0.47). There were differences among hospitals (p<0.001): three hospitals (17%) restricted children from using a bottle, where eight hospitals (44%) allowed bottles, and seven hospitals (39%) had disagreement among their surgeons about whether to restrict bottles after surgery.

Figure 2.

Use of Bottles, Sippy Cups, and Pacifiers After Palate Repair. The proportion of surgeons allowing or restricting the use of each device after palate repair is shown.

Thirty-two percent of surgeons did not allow children to use a sippy cup immediately after surgery (Figure 2B). There was no significant difference in restriction of sippy cup use among surgical specialties (p=1.00). Surgeons who allowed sippy cups after surgery tended to have been in practice longer: surgeons who allowed sippy cups had been in practice for a median of 14 years (IQR 8–22), compared to 4 years in practice (IQR 3–12) for surgeons who did not allow sippy cups usage (p<0.01).

Surgeons at six hospitals (33%) were unanimous in allowing children to use sippy cups. At the twelve remaining hospitals, surgeons disagreed on sippy cup use; at these hospitals, the proportion of surgeons allowing sippy cups ranged from 20% to 80%.

Seventy-one percent of surgeons did not allow children to use pacifiers immediately following surgery (Figure 2C). There was no difference in restriction of pacifier use among surgical specialties (p=0.05), nor was there a difference in years of practice between surgeons who did and did not allow pacifier use (p=0.26). Surgeons at ten hospitals (56%) were unanimous in not allowing children to use pacifiers after palate repair. At the eight remaining hospitals, surgeons disagreed on pacifier use; at these hospitals, the proportion of surgeons allowing pacifiers ranged from 25% to 75%.

Use of Elbow Immobilizers and Mittens

Seventy-three percent of surgeons placed elbow immobilizers after surgery, while another 12% of surgeons placed mittens (Figure 3A). There was no significant difference in elbow immobilizer or mitten placement among surgical specialties (p=0.23) or surgeon years in practice (p=0.27). There were differences among hospitals (p<0.01): at eleven hospitals (61%) all surgeons placed elbow immobilizers, at one hospital (6%) all surgeons placed mittens, at one hospital (11%) neither device was used following surgery; the five other hospitals (28%) had disagreement among their surgeons.

Figure 3.

Use of Elbow Immobilizers and Mittens After Palate Repair. The proportion of surgeons use of each device after palate repair is shown (A), along with the duration of use (B).

Considered together, 85% of surgeons (n = 56) used either elbow immobilizers or mittens postoperatively for a median of 14.0 days (IQR 14–21 days) (Figure 3B). There was no significant difference in duration of use among surgical specialties (p=0.34), surgeon years in practice (p=0.41), or hospitals (p=0.55).

Postoperative Antibiotic Use

The majority of surgeons (n = 36, 55%) did not prescribe postoperative antibiotics (Figure 4A). Among surgeons who did order postoperative antibiotics, cefazolin/cephalexin was the most commonly prescribed (55%), followed by amoxicillin / clavulanic acid (31%) (Figure 4B). There was no significant difference in antibiotic use among surgical specialties (p=0.34), or surgeon years in practice (p=0.55). There were differences among hospitals (p<0.001): four hospitals (22%) never used postoperative antibiotics, where three hospitals (17%) always prescribed antibiotics, and the remaining eleven hospitals (61%) had disagreement among their surgeons.

Figure 4.

Postoperative Antibiotic Duration and Type. The proportion of surgeons using post-operative antibiotics is shown (A), along with the first-choice antibiotic used (B).

Discussion

Surgical practice, in the operating room and beyond, consists of common components adopted by almost all surgeons and contentious components where surgeons disagree; with both the common and contentious components being implemented in highly individualized ways by each surgeon. The present study illustrates this complex construction of surgical practice as it applies to the postoperative management of cleft palate repair. Almost all surgeons impose post-operative diet restrictions and utilize some form of physical device, either elbow immobilizers or mittens, to prevent self-injury. Surgeons disagree, however, about postoperative use of bottles (61% allow), sippy cups (68% allow), pacifiers (29% allow), and antibiotics (45% prescribe). In both the areas where surgeons agree and those areas where they disagree, there is significant individual variation. This variation is not explained by surgeon specialty or years in practice, and surgeon practices frequently vary even within the same hospital. Taken together, the present study provides a picture of cleft palate postoperative management in the United States that is highly individualized by each surgeon.

Our findings on postoperative diet restrictions are consistent with and extend those of prior studies. Katzel et al,³ surveying surgeon members of the American Cleft Palate-Craniofacial Association in 2005, found that 98% of surgeons restricted infants from having hard foods after palate repair, with 40% of surgeons implementing this restriction for at least three weeks. Similarly, Preidl et al,¹³ surveying cleft teams from Europe, North America, and Asia, similarly found that 84% of teams restricted food consistency after palate repair, with 35% of teams starting on a liquid diet immediately after surgery and 35% of teams starting on mashed foods. The present study shows a similarly high prevalence of postoperative diet restrictions and extends these prior investigations by detailing the duration and type of diet restriction. We found that 80% of surgeons allowed infants to consume a pureed or soft diet at two weeks after palate repair, and that 80% of surgeons had stopped all diet restrictions at one month after surgery. Further, most surgeons were comfortable with the use of purees early in the recovery period: 50% of surgeons allowed purees immediately following surgery, with 90% allowing purees at one week after surgery. These findings suggest consensus among surgeons around a post-operative diet protocol beginning with liquids, advancing to purees by one week after surgery, and allowing a regular diet by one month after surgery.

As with the use of postoperative diet restrictions, our study’s finding that 85% of surgeons use either elbow immobilizers or mittens after palate repair is consistent with prior studies. Katzel et al³ found that 85% of ACPA surgeons used some form of arm restraint following palate repair, and that 50% of surgeons used them for two weeks. These results demonstrate high utilization of these devices by surgeons in the United States, theoretically to prevent self-injury of the repaired palate. Interestingly, the high utilization of elbow immobilizers lies in contrast to prior studies showing no benefit of elbow immobilizers in terms of postoperative morbidity,^10,11 and video observations showing that infants do not touch surgical wounds in a traumatic way when unrestrained.⁹ The discord between the lack of published evidence demonstrating efficacy of elbow immobilizers and the high utilization of these devices among surgeons cannot be fully explained by the results of the present study. Rather, these findings may reflect surgeons’ concern over the seriousness of palatal wound dehiscence and their perception of the low morbidity caused by a brief course of elbow immobilizers or mittens.

The present study found ongoing disagreement among surgeons on postoperative use of bottles, sippy cups, pacifiers, and antibiotics. While no prior studies have investigated sippy cup use or pacifier use after palate repair, the disagreement in use of bottles and antibiotics after surgery appears consistent with prior investigations. Katzel et al³ found that 66% of surgeons allowed cleft-adapted bottles after palate repair, compared to 61% in the present study. Similarly, Preidl et al¹³ found that 40% of teams used antibiotics after palate repair, compared to 45% in the present study. There remains a lack of evidence supporting use or avoidance for any of these postoperative practices. The one randomized controlled trial of bottle versus cup feeding found no difference in fistula rates;¹⁴ the one randomized controlled trial of postoperative antibiotics similarly found no difference in fistula rates.¹⁵ Given the paucity of evidence to support a single approach and the entrenched disagreement between surgeons, it is likely that the postoperative use of bottles, sippy cups, pacifiers, and antibiotics will continue to vary by surgeon.

Perhaps the most interesting finding from the present study was that postoperative management practices appear to be highly individualized to each surgeon. Surgeon specialty was not associated with any aspect of postoperative management. Surgeon years in practice, a measure of surgeon experience, was associated only with the management of sippy cup use, with more experienced surgeons tending to be more permissive. At some hospitals, surgeon practice was associated with diet restrictions, bottle use, and use of elbow immobilizers or mittens; but many hospitals still had disagreement among their surgeons. This variation among surgeons in postoperative management may decrease with the adoption of Enhanced Recovery After Surgery (ERAS) programs,¹⁶ which are gaining increased traction within surgical disciplines. Four ERAS programs for cleft palate repair have been recently published,^12,17–20 which may signal ongoing efforts to standardize postoperative care within hospitals.

While our study represents a rigorous analysis of surgeon’s postoperative practices, there are limitations inherent to the study design. First, our findings only represent responses from surgeons participating in the CORNET study. The practices of these surgeons may not generalize to all surgeons who perform cleft palate repair; in particular, surgeons trained and/or working outside the United States are likely to have different experiences, beliefs, and environmental factors that influence their practice. Second, surgeons may change postoperative practices over the course of their career or tailor their postoperative management to fit the needs of individual patients; neither of these behaviors was measured in the present study. As such, generalizations about standard practices may not be possible. Implementation of diet restrictions, elbow immobilizers, mittens, and antibiotics all depend almost entirely on patients and caregivers. What a surgeon recommends may not perfectly align with what is carried out in practice, and patient non-compliance with protocols may influence surgeon preference and perceived efficacy of any given intervention. Lastly, our investigation does not report on short- or long-term surgical outcomes. Future work should correlate surgical outcomes (e.g. fistula incidence) with postoperative protocols to lend greater insight into what may constitute the optimal care plan.

Conclusion

In summary, surgeons almost universally impose diet restrictions after cleft palate repair, but the type and duration of these restrictions vary among surgeons. Neither surgeon specialty nor years in practice was associated with the duration of diet restrictions or length of time before advancement to less restrictive diets. There was a significant difference between hospitals in when patients could be advanced to less restrictive diets. Though this finding suggests that hospital and practice location exert a greater influence on surgeon preference than training background, the subject of postoperative diet restriction remains a controversial one. Most surgeons who practice at the same hospital do not give consistent recommendations, underscoring the reality of continued variability in preferences from surgeon to surgeon. This same pattern was observed for elbow immobilizers and mittens: they were used by almost all surgeons, but with substantial variation in duration. In contrast, there was disagreement between surgeons on the use of bottles, sippy cups, pacifiers, and antibiotic prophylaxis after cleft palate repair. There were no significant differences between surgeons of different specialties for any of these restrictions, though surgeons at different hospitals often had significantly different practices. In short, the hospital at which surgeons practice appears to be one of likely many factors that influence individual surgeon practices for cleft palate repair postoperative management.