Abstract
Background:
Gastrostomy tube (g-tube) complications are typically minor and site related with major complications related to dislodgment before tract establishment. With the recent adoption of 12F g-tubes; size of tube has not been evaluated. There is limited research on the efficacy and dislodgment rates of 12 and 14F g-tubes within the early dislodgment window (<42 days postsurgery).
Materials and Methods:
A retrospective study from June 1, 2013 to May 25, 2020 was performed. A total of 888 patient encounters were identified, with a final data set of 835 being used for analysis. A subset of 21 patients was evaluated based on early dislodgment status. Fisher's exact test and Welch's two-sample test analyses were used to test for significance between groups (P < .05).
Results:
The early dislodgment rate is low at 2.5% (21/835). There was a significant impact of g-tube size on dislodgment rates. When evaluated by g-tube size, 12F g-tubes are nearly four times more likely to dislodge before 6 weeks than 14F g-tubes. In addition, the average age of 12F patients who dislodged early was significantly lower than that of the population for 14F patients.
Conclusions:
There is a significant difference in early dislodgment rate and age between the 12F g-tube compared with a 14F. These data suggest a trade-off of the smaller balloon in 12F g-tubes and potential for more limited use in our smallest children.
Introduction
Gastrostomy feeding tubes are commonly used in the pediatric population for those patients with complex medical care, and especially in those who need long-term nutritional support. An evaluation of the National Trends of gastrostomy tube (g-tube) placements using the Kids' Inpatient Database showed that rates of g-tube placement has increased from 16.6 procedures per 100,000 children in 1997 to 18.5 in 2009. Children <1-year old are experiencing the highest number of g-tube placements, which has increased by 32%. 1 The increasing incidence of surgical intervention has called for the development and evaluation of new and better techniques.
The percutaneous endoscopic gastrostomy (PEG) still commonly performed today was first described in 1980. 2 Since then, several other techniques such as the laparoscopic U-stitch, 3 endoscopic U-stitch, 4 and percutaneous radiologic gastrostomy (PRG) 5 among others have been implemented. Although these techniques have all shown promise in reducing complications, the risk is not down to 0%. Therefore, the increasing incidence of need for enteral feeding becomes an issue and burden from a complication and emergency department (ED) usage perspective. 6 The high-yield focus of such ED presentations occurs within 30 days of their initial discharge while the gastrostomy tract is still healing. Such presentations are as high as 20% of pediatric patients discharged with a g-tube. 7
G-tube dislodgment can result in either major or minor complications and must be taken seriously in both regards. 8 It is significant to note that dislodgment rates are variable in the literature from as low as 1.5% 3 to as high as 27.7%. 9 Further research explores dislodgment rates within cancer and neuromuscular populations with rates of 8.2% 10 and 11.9%, 11 respectively. As with any surgical procedure and recovery process, there are numerous factors to consider when assessing outcomes. With the goal of decreased patient complications and increased patient satisfaction always being the moving target that health care providers are trying to hit, recommendations and preferences are constantly changing.
One seemingly large impact on dislodgment rates has been the utilization of low-profile tubes (3% dislodged) compared with their longer g-tube counterparts (9% dislodged). 12 To take these findings a step closer, a significant difference between two low-profile g-tube dislodgment rates was identified with 33% of Applied Medical Technology mini ones dislodging as compared with 0% of the Bard. 13 The main outcome of interest associated with g-tube dislodgment rates is the need for reoperation to replace the tube, which has been reported as high as 5.3%. 14 These findings are supported and further explored with a more specific goal in mind; identifying major complications within 30 days post-op. After review, 44% of all major complications requiring surgical replacement were due to mechanical complications (dislodgment, intraperitoneal leak, or failed tube placement). 15
Dislodgment can be detrimental to the patient for a variety of reasons as they may be unable to maintain nutritional or fluid needs, or the tract has not healed completely causing an intraperitoneal leak. 16 To help reduce the number of g-tube dislodgments, care bundles and predischarge education have been implemented in some facilities. Providing patients, families, and nursing staff with a care bundle that included proper instructions and utilizing g-tube securement devices reduced their dislodgment rate by 47% compared with precare bundle implementation. 17 With this increase in the number of gastrostomies performed, previous studies have focused on analyzing the various methods of placing g-tubes, their complications, and outpatient management.
With that in mind, little data are out there evaluating the rates of early g-tube dislodgment with respect to tube sizing. All of the dislodgment rates and published findings previously stated were found in populations where 14F g-tubes are the primary tube size. As technology and quality initiatives advanced, 12F low-profile tubes were developed for use in neonates as less invasive and smaller options. With the utilization of 12F g-tube, there has been minimal research interest assessing the dislodgment rates of these smaller tubes. Prior studies explore the impact of tube size as a risk factor for complications, but not dislodgment rates exclusively. 18 Therefore, this single-center retrospective cohort review will look at the rates of early g-tube dislodgment between the 12 and 14F g-tube sizes.
Materials and Methods
After study conception, all materials were compiled and submitted to the local IRB oversight committee for approval (no. 1591520). Once approved, a retrospective chart review at a Children's hospital from June 1, 2013 to May 25, 2020 was performed. Initial inclusion criteria were for all g-tube-related clinic and ED visits (n = 888). Exclusion criteria included any g-tube size other than 12 and 14F (n = 53). This left a final cohort of 12 and 14F g-tube visits over the 7-year review period (n = 835). A subset of early dislodged patients (<42 days post-op) was further evaluated (n = 21).
All statistical analysis was performed using the open source statistical program R (version 4.0.2) against a two-sided alternative hypothesis with a significance level of 5% (P = .05). Dislodgment rates, replacement rates, and age were compared between 12 and 14 drain tube sizes. Owing to the small sample size of the treatment group, Fisher's exact tests were used in lieu of chi-squared tests to compare categorical variables between drain size groups. t-Tests were used to compare continuous variable means between drain size groups.
Results
The population demographics were 56% male with an age range from 0 to 28 years. The overall early dislodgment rate is low at 2.5% (21/835). There was a significant impact of g-tube size on dislodgment rates. When evaluated by g-tube size, 12F g-tubes are nearly four times more likely to dislodge before 6 weeks as compared with 14F g-tubes. In addition, the average age of 12F patients who dislodged early was significantly lower than that of the population for 14F patients. All data elements and tests for significance are found in Table 1.
G-Tube Size Comparisons and Significance Tests
As seen earlier, all tests for significance are conducted at the level of 0.05. Significant differences are denoted with an *. Fisher's exact tests were used for the dislodgment rate and replacement requiring surgical intervention. A Welch's two sample t-test was used for the average age at dislodgment.
SEM, standard error of mean.
Discussion
A significant difference between dislodgment rates of the two groups was identified, with 12F g-tubes dislodging within the early window nearly four times as often (3.56% versus 0.91). Such findings are supported by previous literature showing a higher rate of early tube complications (dislocation, leak, and blockage) from PRG due to the use of smaller diameter tubes when compared with those used in PEG. 19 Although these data are concerned with adults and explores differences in surgical technique, the correlation between higher tube-related complication rates and smaller tube size emphasizes the need for further focused study.
Secondarily to dislodgment as a minor complication, dislodgments that require surgical interventions for replacement are upgraded to major complications. Although surgical placement techniques are out of scope for this study, g-tube replacement requiring surgical intervention was explored and identified within 11% of 12F tube early dislodgments. This differs from the surgical intervention rate of 14F early dislodgments of 0%. Although the difference is not statistically significant due to the small sample size, it is worth noting that the published dislodgment rates of two techniques (PEG and PRG) are 2.6% and 4%–6%. 20 These numbers differ greatly from our findings and offer an area of future more in-depth exploration.
When assessing the growing trend of using the smaller 12F g-tubes in smaller children, first take a step back to explore why and examine the outcomes behind this trend. This study identifies that there is a significant difference in 12F patient's age as compared with 14F patients, with the 12F group being significantly younger (2.17 versus 8.33 years). This finding is logical as surgeons tend to opt for the smaller tube for the smaller patient, which, in the pediatric population, typically corresponds with younger age. In one retrospective analysis, 75% of patients had a 12F tube initially in place with 41% undergoing an upsize at a subsequent encounter. This showcases the high utilization of 12F g-tubes in recent practice as well as the need to upsize to a larger tube over the length of care. 21
Prior literature defines and offers significant areas where room for improvement is greatly needed, particularly with respect to complication rates. 22 Many of the common minor and major complications are identified and reported, but there is a lack of large-scale broad data assessing the prevalence and detriment of said complications.
Conclusion
In conclusion, there is a significant difference in early dislodgment rate and age at early dislodgment for children with a 12F g-tube compared with a 14F. The data suggests a trade-off of the smaller balloon in 12F g-tubes and potential for more limited use in our smallest children. Targeted education of hospital staff and families along with elective change sooner than 6 weeks are potential opportunities in the improvement of care for these children.
Footnotes
Authors' Contributions
All authors contributed to the creation, execution, and publication of this project equally. P.M.J. and C.J.A. were involved in the prestudy planning, project oversight, data interpretation, writing, and editing processes. R.S.F. was involved in the prestudy planning, IRB drafting and observation, data abstraction, statistical analysis, data interpretation, writing, and editing processes. Finally, J.L. and S.C.C. were involved in the data abstraction, writing, and editing processes.
Acknowledgment
We acknowledge the efforts of our institutional statistician, Mark Shadden, for his work on this project.
Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.
