Perioperative Antibiotics Are Independent Predictors for Major Complications in Pediatric Patients Undergoing Gastrostomy Placement

Abstract

Introduction:

Although rare, major complications after gastrostomy tube placement are a significant source of morbidity in children. The purpose of this study was to identify predictors of major complications in pediatric patients undergoing gastrostomy placement.

Materials and Methods:

Retrospective review of surgically placed gastrostomy tubes from 2010 to 2017 was performed. Data collected included demographics, outcomes, and major complications. We divided the patients into no complications (Group 1) and major complications (Group 2). Excluded were minor complications and percutaneous endoscopic gastrostomy procedures.

Results:

Of 123 patients, 51.5% were males and 52% infants. Group 1 had 112 patients (91%), whereas Group 2 had 11 patients (9%). Of Group 2 patients, 3 required prolonged nil per os/total parenteral nutrition and 8 surgical reinterventions. Laparoscopy in 110 patients (89%), open surgery in 10 patients (8%), and 3 conversions to open. There were no significant differences in demographics or preoperative characteristics (albumin and comorbidities). We identified surgical approach (open: 6.3% versus 27.3%, P = .014), operative time (58 versus 85 minutes, P = .04), and use of preoperative antibiotics (63% versus 92%, P = .004) as predictors of outcomes. However, on multivariate analysis lack of preoperative antibiotics (adjusted odds ratio [aOR], 14.82 [confidence interval: 2.60–84.34], P = .002), and open procedure (aOR, 6.14 [1.01–37.24], P = .049) were independent predictors of major complications.

Conclusion:

Most patients with major complications after gastrostomy tube placement require surgical reintervention. Lack of preoperative antibiotics and open procedures are independent predictive factors for major complication in patients undergoing gastrostomy tube placement.

Introduction

Gastrostomy tube placements are commonly done to provide or supplement long-term nutritional needs. In the pediatric population, gastrostomy tubes are often placed for failure to thrive and feeding intolerance.¹ There are three main types of tubes: a percutaneous endoscopic gastrostomy (PEG) tube, long “traditional” gastrostomy tube, and a low-profile gastrostomy button.² Laparoscopic method is the preferred approach for gastrostomy placement, and can be used in infants weighing <2 kg.^3,4

Various studies have compared complication rates after different tubes and different gastrostomy tube placement methods. Studies have consistently shown higher complication rates with PEG procedures.⁵ Some of these complications include dislodgement, leakage, granulation tissues, pain, and malposition of the tube.² In the pediatric population, postoperative complications are higher in PEG tube placement with the pull-through method.⁶ As a result, the laparoscopic method has been established as a superior method in children <5 years of age.¹

Some of the common complications after gastrostomy tube placements include dislodgement, granulation tissue, leakage, tube blockage, skin maceration, cellulitis, and abdominal distention. Although rare, major adverse events such as mortality and cardiac arrest are also more common in children undergoing gastrostomy tube placement than those undergoing other operations. One study has shown intraoperative sepsis, brain tumor, severe cardiac risk factors, as well as intraoperative seizure history as significant factors that increase the risk of postoperative adverse events.⁷

Despite the safety of gastrostomy devices, minor complications occur in up to 60% of patients.⁸ However, major complications after gastrostomy tube placement are rare but a significant source of morbidity in children. The purpose of this study was to identify predictors of major complications in pediatric patients undergoing gastrostomy placement. We hypothesized that history of cyanotic cardiac disease, nutrition status, and prior Nissen fundoplication would serve as significant predictors of major complications.

Materials and Methods

A retrospective study of surgically placed gastrostomy devices in a single tertiary pediatric center from 2010 to 2017 was performed. Data collected included demographics and outcomes with interest in major complications. The primary clinical outcome of interest was major complication within 90 days of surgery. Preoperative albumin and prealbumin were used to assess nutritional status of the patients. Complications reviewed were gastroesophageal reflux, feeding intolerance, conversion of gastrostomy device to gastrojejunostomy tube, wound infection, device dislodgement, peristomal bleeding, hypergranulation tissue, and external gastric content leaks. Major complication was defined as complications requiring prolonged (>2 weeks) nil per os (NPO) and total parenteral nutrition (TPN), and/or surgical intervention. We compared patients with no complications (Group 1) to major complications (Group 2). Patients who underwent laparoscopic or open procedures were included in the study and analysis. We excluded patients with minor complications in our study. Patients who underwent PEG tube placement were excluded.

For continuous data, the mean with standard deviation and median with interquartile range (IQR) were calculated. Categorical data were represented as frequencies and percentages.

Groups were compared using chi-square test for categorical data and independent t-test for continuous data. Multivariable logistic regression was performed to analyze the effect of covariates on major complication. Covariates chosen for the model were based on a priori knowledge, P value of ≤.20, and also those who did not have >5% of the data missing.

Two-sided P value of ≤.05 was considered significant. All analyses were performed using SPSS^® version 24 (IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp.). Study was approved by Saint Louis University institutional review board (study no.: 28838).

Results

There were 265 patients identified within the study period; of these, 142 patients (54%) had minor complications and were, therefore, excluded from the study and analysis. One hundred and twenty-three patients (46%) comprised the study cohort: 72 (58.5%) were males, 52% were infants, and 56% weighed ≤10 kg. Congenital cardiac disease was present in 28.5% of the patients. Eleven percent of the study population did not receive intraoperative antibiotics as recommended by the Surgical Care Improvement Project (SCIP) protocol.⁹ Seventy-three percent of the cohort had gastrostomy buttons placed as the primary device. Laparoscopic approach was used in 110 (89%) of the patients. However, 3 patients required conversion to open procedure. The median operative time was 44 minutes (IQR, 34–70) and the median hospital length of stay was 22 days (IQR, 3–62). Study cohort data are presented in Table 1. There were 112 (42%) patients in Group 1, whereas Group 2 had 11 (4%) patients (Table 2). Of Group 2 patients, 3 (27%) required prolonged NPO/TPN and 8 (73%) required surgical intervention.

Table 1.

Study Demographic Characteristics

Variables	Incidence (n = 123)
Gender
Male	72 (58.5)
Female	51 (41.5)
Age distribution (months)
0–12	64 (52)
13–60	24 (19.5)
>60	35 (28.5)
Weight distribution (kg)
0–10	69 (56.1)
10.1–15	19 (15.4)
>15	35 (28.5)
History of congenital cardiac disease	35 (28.5)
Intraoperative antibiotics given	110 (89.4)
Type of surgical approach
Laparoscopic	110 (89.4)
Open	10 (8.1)
Lap converted to open	3 (2.4)
Type of tube
G-tube	33 (26.8)
G-button	90 (73.2)
Operative time (min)
Mean	60.3 (43.4)
Median	44 (34–70)
Range	21–284
Hospital length of stay (days)
Mean	67 (144)
Median	22 (3–62)
Range	1–1296

Data are presented as n (%), mean ± SD or median (interquartile range).

G-button, gastrostomy button; G-tube: gastrostomy tube; SD, standard deviation.

Table 2.

Major Complications Among Gastrostomy Patients

Major complications	Number of patients
NPO/TPN due to external leaks	3
External leaks requiring surgery	3
Hypergranulation tissue requiring surgery	3
Device dislodgement requiring surgery	2

External leaks: leakage of gastric contents.

NPO/TPN, nil per os/total parenteral nutrition.

In the univariate analysis there were no significant differences between Group 1 versus Group 2 in terms of gender, age distribution, weight distribution, preoperative nutrition, American Society of Anesthesiologists classifications, Nissen fundoplications at the time of gastrostomy and intraoperative comorbidity of congenital cardiac disease. However, we identified significant differences in surgical approach (open approach: 6.3% versus 27.3%, P = .014), operative time (58 versus 85 minutes, P = .04), and lack of intraoperative antibiotics (8% versus 36%, P = .004) between the two groups (Table 3). We did observe a statistical difference in patients with prior Nissen fundoplication, but there was only 1 patient in each group.

Table 3.

Univariate Analysis of Patients with No Complication and Major Complication

Variables	No complication (n = 112)	Major complication (n = 11)	P
Gender			.719
Male	65 (58)	7 (63.6)
Female	47 (42)	4 (36.4)
Age distribution (months)			.984
0–12	58 (51.8)	6 (54.5)
13–60	22 (19.6)	2 (18.2)
>60	32 (28.6)	3 (27.3)
Weight distribution (kg)			.966
0–10	63 (56.3)	6 (54.5)
10.1–15	17 (15.2)	2 (18.2)
>15	32 (28.6)	3 (27.3)
ASA distribution			.101
I	1 (0.9)	0
II	16 (14.3)	4 (36.4)
III	80 (71.4)	4 (36.4)
IV	15 (13.45)	3 (27.3)
History of congenital cardiac disease	31 (27.7)	4 (36.4)	.542
Type of cardiac disease			.593
Cyanotic cardiac disease	12 (38.7)	1 (25)
Noncyanotic cardiac disease	19 (61.3)	3 (75)
Intraoperative antibiotics not given	9 (8)	4 (36)	.004^a
Preoperative albumin	3.6 (0.5)	3.4 (0.4)	.486
Preoperative prealbumin	17 (7.3)	18 (14.5)	.757
Prior Nissen fundoplication	1 (0.9)	1 (9.1)	.040^a
Nissen+G-tube	7 (6.3)	2 (18.2)	.147
Type of surgical approach			.014^a
Laparoscopic	103 (92)	7 (63.6)
Open	7 (6.3)	3 (27.3)
Lap converted to open	2 (1.8)	1 (9.1)
Type of tube			.455
G-tube	29 (25.9)	4 (36.4)
G-button	83 (74.1)	7 (63.6)
Operative time (min)	57.8 ± 43.3	85.8 ± 37	.040^a

Data are presented as mean ± SD or n (%).

Statistically significant.

ASA, American Society of Anesthesiologists; G-button, gastrostomy button; G-tube, gastrostomy tube.

Importantly, there was no significant difference in complication regardless of the type of gastrostomy tube placed although more primary gastrostomy buttons were placed than gastrostomy tubes in both groups. The factors predicting major complication in our cohorts were lack of intraoperative antibiotics (adjusted odds ratio [aOR], 14.82 [confidence interval: 2.60–84.34], P = .002) and open procedure (aOR, 6.14 [1.01–37.24], P = .04) as shown in Table 4.

Table 4.

Multivariable Analysis of Major Complication of Gastrostomy Procedures

Covariates	aOR (95% confidence interval)	P
Gender
Female	Reference
Male	1.39 (0.28–7.06)	.690
Age distribution (months)
>60	Reference
0–12	7.46 (0.02–2700.04)	.504
13–60	1.49 (0.03–75.09)	.843
Weight distribution (kg)
>15	Reference
0–10	0.17 (0.01–52.90)	.543
10.1–15	1.33 (0.03–68.31)	.887
Congenital cardiac disease
Absent	Reference
Present	1.18 (0.22–6.19)	.848
Intraoperative antibiotics
Given	Reference
Not given	14.82 (2.60–84.34)	.002^a
Surgical approach
Laparoscopic	Reference
Open	6.14 (1.01–37.24)	.049^a
Lap converted to open	3.54 (0.17–72.55)	.412
Type of tube
G-button	Reference
G-tube	1.61 (0.31–8.30)	.569
Mean operative time (min)	1.01 (1.00–1.03)	.129

Statistically significant.

aOR, adjusted odds ratio; G-button, gastrostomy button; G-tube, gastrostomy tube.

Discussion

Gastrostomy tubes are safe and effective for long-term enteral nutrition support. They are more reliable than nasoenteral tubes.¹⁰ Although major complications of gastrostomy tubes are rare, they can be debilitating and catastrophic to patients and exhausting for caregivers. For most studies major complication is defined as the need for surgical intervention or death.^8,11–13 Report of major complications, however, differ based on the technique and duration of follow-up postoperatively. Notwithstanding these differences, range of major complications reported in literature are 0%–13%.^3,4,8,13,14

Results of our study show that factors most predictive of major complications are open surgical approach and nonadministered intraoperative antibiotics. Upon reviewing the reasons why antibiotics were not given to these patients, we found that they were already on therapeutic antibiotics. Twenty-seven percent of the patients in Group 2 who underwent open gastrostomy placement had major complications. This was significantly higher than those in Group 1. When comparing techniques of gastrostomy tube placement, Sulkowski et al.¹⁵ noted the rate of tube dislodgement to be higher in open gastrostomy and a third of these patients needed intervention. In contrast, Angsten et al.¹⁶ in comparing laparoscopic versus open found no difference in complication rates. Likewise, Baker et al.¹⁷ also noted no difference in major complication in a meta-analysis between open gastrostomy versus laparoscopic approach or open versus PEG. There are variations in the incidence of reported complications with no uniform definition of minor and major complication, hence the differences in outcomes of various studies. Open surgical approach had a strong association with major complication in the univariate analysis; however, when adjusted for other covariates its association with the primary outcome was weak.

Interestingly, history of cardiac disease and nutritional status were not predictors of major complications. We did observe statistical significance for patient with prior Nissen fundoplication, but there was only 1 patient on each group. In our analysis, the factor with the strongest association with major complication was intraoperative antibiotics. Patients who did not receive prophylactic intraoperative antibiotics were >14 times likely to have major complication when compared with those who received intraoperative antibiotics. Studies evaluating PEG tube placements have noted that routine prophylactic intraoperative antibiotics help decrease the risk of complications.^18,19 In an Italian multicenter observational study by Fascetti-Leon et al.,²⁰ 46% of patients who underwent PEG tube placement had prophylactic antibiotics, and there was no significant difference in infection between patients who had prophylactic antibiotics and those who did not. Nonetheless, the use of antibiotics prophylaxis was an independent risk factor for complications within 12 months of surgery. These results indicate that therapeutic antibiotics are protective of complications in this patient population.

This retrospective study is limited in several ways: patient heterogeneity and selection introduce bias that may not be accounted for, although there were no major differences in demographics and preoperative characteristics. Also, in other studies patient comorbidities involving neurological, respiratory, and gastrointestinal systems were accounted for; however, in this study we were only interested in patients with history of congenital cardiac disease, nutritional status, and history of Nissen fundoplication. Lastly, we did not determine the predictive factors of each complication making up the major complication because of our small sample size.

Overall, surgical gastrostomy tube offers low rate of major complication (4%); however, intraoperative antibiotics and open surgery are associated with major complication. Open gastrostomies are difficult to control for, due to the fact that sometimes patient characteristics require an open procedure. However, lack of intraoperative antibiotics is a controllable variable, and the use of strict intraoperative antibiotics guidelines may influence outcome. Since this study, our group has changed the practice to give perioperative antibiotics within 1 hour of incision, regardless of whether or not patient is on a scheduled antibiotics regimen.

In conclusion, most patients with major complications after gastrostomy tube placement require surgical reintervention. Lack of preoperative antibiotics and open procedures are independent predictive factors for major complication in patients undergoing gastrostomy tube placement.

Authors' Contributions

Study conception and design was done by G.V.; J.S.K., S.K., and J.M. did the literature review; research protocol for IRB approval, abstract, method, result, and discussion were by H.O. and A.S.M.-A.; H.O., A.S.M.-A., J.S.K., S.K., and J.M. did the data collection; data analysis was done by H.O., A.S.M.-A., and G.V.; H.O. and J.M. contributed the introduction; review of drafts and editing by K.C., J.G., C.F., and G.V.

Footnotes

Disclosure Statement

No competing financial interests exist.

Funding Information

This study was self-funded by Department of Pediatric Surgery, SSM Cardinal Glennon Children's Hospital. No funding was received from any agency, company or individual.

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