The Outcome of Late versus Early Ileostomy Closure at Low Body Weight (<1500 g) in Babies with Necrotizing Enterocolitis.

Aim: The aim of this study is to determine the surgical outcome of ileostomy closure at low body weight (<1500 g) and to find any differences in complications and growth of infants whose ileostomy was reversed early (4-6 weeks) versus late (8-10 weeks).
Methods: A prospective comparative study was conducted on patients who underwent ileostomy reversal created for necrotizing enterocolitis from January 2017 to December 2019. The patients were divided into two groups: group 1 (early ileostomy closure) between 4 and 6 weeks and Group 2 (late closure) between 8 and 10 weeks. The primary outcome was expressed as the presence of anastomotic leak, obstruction, perforation, wound infection, sepsis, and death.
Results: A cohort of 31 patients with 16 patients in Group 1 and 15 in Group 2 were studied. The mean duration between ostomy creation and reversal was 5.1 ± 0.63 weeks in Group 1 and 8.9 ± 0.66 weeks in Group 2. The mean weight at reversal was 1435.5 ± 163.8 g for patients in Group 1 and 1405 ± 99.93 g for patients in Group 2. Weight gain at 90 days in Group 1 was 895 ± 85.2 g and in Group 2 was 455 ± 34.6 g, which was statistically significant (P < 0.00001). Parenteral nutrition, ability to reach full enteral nutrition, and total ventilator days, mortality rate, and complications were not statistically different between the groups. The overall survival rate was 87.27%. Conclusions: Ileostomy reversal at a lower weight and within 6 weeks was not associated with an increased risk of complications. Early stoma reversal may help in weight gain. Copyright:

INTRODUCTION

Neonatal necrotizing enterocolitis (NEC) is one of the most common gastrointestinal emergencies in preterm, low birth weight neonates.[1] Operation is indicated in 20%–40% of patients with Stage 3 NEC when there is evidence of gangrenous intestine.[2] Laparotomy with surgical resection and enterostomy formation remains the most commonly accomplished procedure. Premature infants with an enterostomy are susceptible to diverse stoma-associated complications.[3] Early closure can have the benefits of avoiding stoma-related complications. It helps to maintain fluid and electrolyte balance by preventing high-volume enterostomy output. In addition, enterostomy closure can also be beneficial for caregivers if done at the same hospital admission. However, in comparison, these susceptible patients can have unforeseen postoperative complications because of their immaturity if the enterostomy is closed too early.[4]

The timing for enterostomy closure is conventionally determined by the preferences or experiences of a surgeon. Some surgeons advocate early enterostomy closure before 6 weeks,[56] while others prefer to delay the repair for at least 8–10 weeks or until the baby weighs more than 2.5 kg.[78] Many families do not have adequate resources or incompetent to take care of stoma at home and these infants are slow to gain weight.

There is currently no consensus regarding the best time for reversal of enterostomy. The study aimed to analyze the outcome of infants whose enterostomy was reversed earlier than 6 weeks as compared to those later than 8 weeks after the initial ostomy creation.

METHODS

This prospective, comparative, observational study was undertaken in Central India at a tertiary care referral neonatal intensive unit. From January 2017 to December 2019, 31 preterm, gestational age <35 weeks, and weight <1400 g neonates with distal ileostomy created for NEC were prospectively analyzed. The Institutional Review Board approved the study protocol. Written informed consent was obtained once the patient survived the initial laparotomy with resection of the nonviable segment (s) of bowel and enterostomy formation.

We included neonates with NEC with a distal ileostomy, out of ventilator support, able to breathe spontaneously, and without any major passage delay evident on distal loop contrast studies. NEC neonates with a jejunostomy, congenital gastrointestinal anomalies, major cardiac problems, and intraventricular hemorrhage were excluded

Allocation of the first case was done by picking the token, and all cases were then alternatively assigned to two treatment groups. Group 1 (early closure) contained 16 and Group 2 (late closure) had 15 patients. Early ostomy closure (EC) was described as a closure of the ostomy in a time frame of 4–6 weeks after ostomy formation while closer between 8 and 10 weeks formed the late ostomy closure (LC) group. All patients were treated by the same pediatric and surgical team. In the first operation, the patients had a mid-transverse abdominal laparotomy and double-barrel enterostomy stoma creation. The continuity of the bowel was restored by end-to-end anastomosis in two layers, first continuous and next with interrupted vicryl 5/0 sutures. We assessed for morbidities of anastomotic leak, perforation, intestinal obstruction, wound infection, sepsis, and death.

Statistical analysis

The data were compiled and analyzed using the software SPSS 20 is short for Statistical Package for the Social Sciences group of software packages developed and marketed by IBM for windows. Appropriate univariate and bivariate analysis were carried out using the Student's t-test for the continuous variable and Chi-square test for categorical variables. All means are expressed as the mean ± standard deviation for continuous data, while qualitative information is expressed in proportion with a percentage. A P < 0.05 was considered statistically significant.

RESULTS

This cohort of 31 patients had 9 boys in Group 1 and 8 boys in Group 2, with a mean gestational age of 30.40 ± 3.87 weeks in Group 1 and 31.20 ± 2.92 weeks in Group 2. Maternal and neonatal data of the enrolled neonates are shown in Table 1.

Table 1

Demographic data of the cohort

Parameters	Group 1, n (%)	Group 2, n (%)
Maternal data
Age (years)	31.6±4.73	32.1±5.01
Maternal diabetes	3 (18.8)	2 (13.4)
Maternal hypertension	4 (25)	3 (20)
Preeclampsia	1 (6.3)	0
Antepartum hemorrhage	2 (12.5)	1 (6.7)
Antenatal corticosteroid	2 (12.5)	3 (20)
Mode of delivery (vaginal)	12 (75)	11 (73.4)
Clinical data at the time of delivery
Apgar score at 1 min (≤5)	6 (37.5)	5 (33.4)
Apgar score at 5 min (≤5)	5 (31.3)	5 (33.4)
Use of resuscitation drugs	3 (18.8)	4 (26.7)
Use of surfactant	4 (25)	4 (26.7)
Mode of feeding
Breast	9 (56.3)	10 (66.6)
Formula	7 (43.7)	5 (33.4)

The mean weight at birth was 1107.8 ± 70.97 g in Group 1 and 1095.5 ± 77.39 g in Group 2. The postnatal age at the onset of NEC was 13.04 ± 3.54 days in Group 1 and 12.96 ± 2.74 days in Group 2. The gestational age and weight at birth between the two groups were similar. The length of the resected segment at first operation was 5.3 ± 1.5 and 5.6 ± 0.8 inch in Group 1 and Group 2, respectively. The most common postoperative complications after the first operation were sepsis and other surgical complications as shown in Table 2. The mean duration between ostomy creation and reversal was 5.1 ± 0.63 weeks in Group 1 and 8.9 ± 0.66 weeks in Group 2. The mean weight at reversal was 1435.5 ± 163.8g for patients in Group 1 and 1405 ± 99.93g for patients in Group 2. Weight gain at 90 days was 895 ± 85.2 g in Group 1 and was 455 ± 34.6 g in Group 2, which was statistically significant (P < 0.00001) [Table 3]. The progression of the weight of the patients in this cohort is shown in Figure 1.

Table 2

Postoperative complications after ostomy formation

	Group 1, n (%)	Group 2, n (%)	P
Sepsis	13 (81.2)	11 (73.4)	0.598
Peristomal excoriation	12 (75)	13 (86.7)	0.411
Pneumonia	6 (37.5)	5 (33.3)	0.808
Wound infection	3 (18.8)	4 (26.7)	0.665
Wound dehiscence	1 (6.3)	1 (6.7)	0.962
Burst abdomen	1 (6.3)	0	0.324
Ileostomy retraction	1 (6.3)	1 (6.7)	0.962
Ileostomy prolapse	1 (6.3)	1 (6.7)	0.962

Table 3

Comparison of weight at birth, ostomy, reversal, and 90 days between groups

Weight	Mean±SD		P
	Group 1 (g)	Group 2 (g)
At birth	1107.8±70.97	1095.5±77.39	0.648
At ostomy formation	1085.4±69.56	1077±71.67	0596
At ostomy reversal	1435.5±163.8	1405±99.93	0.538
At 90 days	1987.3±26.79	1547.3±43.75	<0.000001
Weight gain at 90 days of life (g)	895±85.2	455±34.6	<0.000001

SD: Standard deviation

Figure 1

Progress of mean weight in both groups

Parenteral nutrition, ability to reach full enteral nutrition, and total ventilator days were not statistically significant between groups as shown in Table 4.

Table 4

Comparison of variables between groups after ileostomy closure

	Group 1	Group 2	P
Ventilation (days)	3±1.74	4±2.89	0.041
Vasopressors (days)	8±2.18	9±3.27	0.076
Parenteral nutrition	8.5±4.40	9±4.39	0.568
Time to full enteral feeding	14.5±3.22	15±3.81	0.216
Length of hospitalization (days)	21.3±2.3	24.4±2.16	0.117

One patient in Group 1 and all patients in Group 2 were discharged home and returned for ostomy reversal at a later date. The mortality rate was not statistically different between the groups. Complications following ostomy reversal were found to be similar between the groups [Table 5]. Three patients required reoperation; one in Group 1 and two in Group 2. The length of stay in the neonatal intensive care unit after ileostomy closure was 18–25 days in Group 1 and 19–27 days in Group 2. The overall survival rate was 87.27%.

Table 5

Postoperative complications after ileostomy closure

	Group 1, n (%)	Group 2, n (%)	P
Wound infection	3 (18.8)	5 (33.3)	0.605
Intestinal malfunction	5 (31.3)	3 (20.0)	0.760
Postoperative sepsis	2 (12.5)	1 (6.7)	1.0
Intestinal obstruction	1 (6.3)	0	0.324
Anastomotic leak	0	1 (6.7)	0.293
Perforation	0	1 (6.7)	0.293
Incisional hernia	1 (6.3)	1 (6.7	0.964
Mortality	0	1 (6.7)	0.293

DISCUSSION

The appropriate timing for reversal of ostomy in neonates with NEC has been debated. Some advocate stoma reversal at 3–6 weeks from the time of creation or at the time the neonate attains a weight of at least 2000 g.[9] Several surgeons felt that repeat laparotomy any time earlier than 10 weeks increased the complication of the operation,[7] while others believed that reversal should occur once a neonate has all other comorbidities stabilized.[8]

In premature neonates with NEC, enterostomy provides the distal intestine to rest and recover from inflammation.[410] However, a significant reason for the early reversal of enterostomies is to increase the absorption of enteral nutrients, to promote earlier use of the entire available gut, thereby reducing parenteral nutrition burden, caretaker comfort, and discharge planning.

The present study demonstrates that early stoma closure in infants who underwent surgery for NEC does not influence postoperative outcomes and complications.

In 1985, Cogbill and Millikan were the first to report in-depth on the outcome of NEC neonates who underwent stoma formation and restoration of intestinal continuity. With cutoff at 8 weeks, they pointed that 100% of the infants with a jejunostomy and 69% with an ileostomy had experienced severe dehydration, electrolyte imbalance, and acidosis.[11] Veenstra et al. stated that the length of hospital admission was shorter in infants who had the stoma closed earlier.[12] They found no major variations in total parental nutrition (TPN)-related cholestasis, TPN duration, or mechanical ventilator period. Mortality or complications showed no significant difference between groups (<8 weeks, 8–12 weeks, and >12 weeks from the creation). The authors concluded that stoma closure should be considered within 6 weeks during the same admission of the initial laparotomy after patient stabilization.[12] Gertler et al.[13] in a prospective study on early closure of ileostomy following NEC concluded that early ileostomy closure was feasible and safe in infants weighing as low as 1.9 kg. They also noted that normal intestinal function and accelerated growth were achieved readily after intestinal continuity was restored, thus minimizing possible metabolic and nutritional complications. Rothstein et al. suggested that early closure would be beneficial in patients with chronic dehydration and an electrolyte imbalance as an adaptation to the intestine is obtained within the first few weeks of stoma closure.[14] Musemeche et al.[9] evaluated the patients at the time of enterostomy closure, based on their weights. Complications were seen in 24% of patients who were <2.5 kg and in 20% with a weight between 2.5 and 5.0 kg. On this basis, it was reasoned that the early reversal did not increase the morbidity rate. In a meta-analysis, Zaini et al. observed that the timing of EC did not affect the duration of TPN use, hospital stay, or complications when patients were divided based on the enterostomy duration of 8 weeks.[15]

In contrast, several authors[71617] found long hospital stays, prolonged periods of mechanical ventilation, longer need for parenteral nutrition, and more days to reach full enteral feeding in neonates who were reversed before 10 weeks. They advised that, unless indicated, the closure of the stoma should be postponed until 10 weeks after its formation.

All patients did not undergo ostomy reversal during the same hospitalization as ostomy creation. One patient in Group 1 and all patients in Group 2 were discharged home and returned for ostomy reversal at a later date. Previous studies reported the complication rate after ileostomy closure ranging from 0% to 15%, the frequency of anastomotic leaks ranging from 0% to 8.3%, and the rate of small bowel perforations ranging from 0% to 3.2%.[181920] In this study, 16.2% of the patients developed surgical complications associated with ileostomy closure. The reoperation in this cohort was three (9.7%); one each for obstruction, anastomotic leak, and perforation. Group 1 had one obstruction due to adhesion and required adhesiolysis at 46 days after enterostomy closure. This child had two additional admissions before the third operation. In Group 2, one patient developed an anastomotic leak, and on the 6th postoperative day, ileostomy was refashioned. Another child in Group 2 developed perforation. On the 4th day, ileostomy was remade. This child went into sepsis, ARDS, and expired on day 27. Our results are comparable to the incidence reported in other earlier studies.

In this series, the need for postoperative ventilation, parenteral nutrition, and duration to establish full feeds were statistically not significant between groups. The incidence of wound infection ranges from 0% to 18.3% in the literature.[18] Wound infection and sepsis (25.80%) were seen in both groups. This is partly due to immature immunological protection and inadequate nutritional reserve, which makes these patients more susceptible to poor wound healing and thus increases their susceptibility to infection. Until now, it is uncertain if body weight should be a criterion for assessing the timing of stoma closure. Talbot et al.[21] showed that stoma reversal at a lower weight (<2 kg) was not associated with a higher risk of perioperative complications. However, others found a weight of <2.5 kg to be a significant influence for anastomotic dehiscence.[822] In the current series, all patients were below 2 kg and three (9.7%) developed an intestinal complication. Bethell et al.[23] found a substantial weight gain after enterostomy reversal, regardless of gestational age at birth or occurrence of enterostomy-related complications.

In this study, the weight gain at 90 days after stoma formation was statistically higher in Group 1, as compared to Group 2. It offers assurance on the development of these patients who have struggled to thrive in early life. An early closure has several advantages. It can prevent and treat electrolyte imbalance and dehydration,[1424] it has equivalent wound infection,[5] and it could promote growth.[23]

We acknowledge several limitations to this study. It was limited by its relatively small cohort of patients, single-institution sampling, and observational nature of the data. In the first group, all but one patient remained in the hospital for their entire time of care. In the second group, the patients were discharged home and came back for ileostomy closure. Therefore, the care of the second group was not at hospital environment throughout the study duration. A multicenter randomized controlled trial with a large sample would be essential in future.

CONCLUSIONS

In infants operated for NEC, early ileostomy closure seems to be safe and was not associated with poor surgical outcomes. Early closure (4–6 weeks) of an ostomy and weight <2 kg in infants did not lead to significant surgery-related complications.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.