Necrotizing enterocolitis (NEC) is considered one of the most common gastrointestinal emergencies in newborns and represents a major cause of mortality 1.
The incidence of NEC is inversely related to the birth weight of affected neonates, hence affecting babies with low birth weight 2.
Classically, NEC is categorized into medical and surgical NEC depending on the clinical criteria such as refusal to feed, abdominal distention, vomiting, radiological positive or negative findings (free air, intestinalis pneumatosis, and air within the portal vein), and laboratory data such as thrombocytopenia, leukopenia, and positive blood culture 3–5.
Considerable controversy exists on the management of surgical NEC either by laparotomy or by primary peritoneal drainage 6.
Laparotomy in low birth weight infants is usually associated with 35–53% mortality and poor neurodevelopmental outcomes 7.
Bedside peritoneal drainage is performed under local anesthesia for extremely sick low birth weight neonates as an alternative to traditional laparotomy 8.
Surprisingly, some of these neonates survive. We aimed to evaluate primary peritoneal drainage versus traditional laparotomy.
Patients and methods
Fifty-six cases who presented with surgical NEC were studied during the period from March 2013 to March 2016. They were subdivided into two groups. Group A included cases treated by peritoneal drainage. Group B included cases treated by laparotomy. We excluded cases with severe manifestations and unsuitable for formal exploration and who had been subjected to a drainage procedure as a damage control strategy. Also, we excluded extremely low birth weight babies as they would not have been able to tolerate the exploration. All cases had plain erect abdomen, abdominopelvic ultrasound, complete blood count, C-reactive protein, blood culture, and arterial blood gases. We inserted a central venous catheter in all cases and total parenteral nutrition (TPN) was planned. Cases were all candidate for either exploration or drainage as lines of management. They were randomized into two groups: A and B. Group A included cases that received primary peritoneal drainage as a definitive treatment. Group B included cases that were subjected to laparotomy. In group A, lidocaine 2% at a dose of 0.05 mg/kg was infiltrated into subcutaneous planes in the right lower abdominal quadrant. A full-thickness incision 1 cm in length was performed. The pus or intestinal contents were expressed manually. Then, we irrigated the peritoneal cavity with warm saline until wash became clear. Drain was inserted and fixed to the anterior abdominal wall. Daily record of the output was obtained. Clinical and laboratory correlations were recorded. Deterioration of general condition despite the presence of drain called for termination of this line of management and formal exploration was planned, provided that there was no severe metabolic acidosis or respiratory impairment. Follow-up of stable cases was performed. After 3–7 weeks of TPN and after the patient had an open bowel, we initiated oral intake gradually. In group B, formal exploration through the right upper abdominal transverse incision was performed. Resection of the bowel, iliostomy, or primary repair of the gut were performed according to the condition of the babies. Follow-up with TPN for 3–7 weeks was performed. Oral intake was initiated gradually as tolerated by the babies.
The study had ethical committee approval.
Fifty-six cases who presented with surgical NEC were studied during the period from March 2013 to March 2016. They were divided into two groups. Patients in group A were treated by primary peritoneal drainage. Group B included patients who were treated by traditional laparotomy. The baseline features and clinical data were almost the same for both groups in terms of birth weight, gestational age, platelet count, C-reactive protein, blood culture, clinical presentation, and radiological findings (Table 1).
The primary outcome variable was survival of the patients after either procedure. In group A, six (22.3%) patients died, whereas in group B, seven (24.4%) patients died; this was not significant. Radiological findings, birth weight, and platelet count had no significant effects on the mortality rates.
The mean hospital stay in group A was 37.36 days, with a SD of 5.09, whereas in group B, it was 41.17 days, with a SD of 4.6. This was significant.
There were no significant differences between the two groups in the dependence on TPN after the intervention. Oral intake was initiated just after the patient had an open bowel, no or minimal drain residual, absence of inflammatory mediators, and improved general condition.
Three cases in group A were treated by laparotomy after days 2–5 after drainage because of deterioration of the general condition and high output of drain. One of these patients died.
Ventilator support was required in 25 cases for a mean period of 21 days in group A. However, in group B, ventilator support was required in 26 cases for a mean period of 30 days (Table 2 and Figs 1 and 2).
The overall survival after 51 days of admission in neonatal ICU in groups A and B was illustrated using a Kaplan–Meier curve. In group A, five cases died, whereas in group B, six cases died (Fig. 3).
Primary peritoneal drainage was introduced for the first time by Ein and colleagues, who described it as an interval procedure for the treatment of neonates of very low birth weight babies who might not tolerate traditional laparotomy 9,10.
Since then, some studies have depended on this procedure as a temporary method until stabilization of patients and then proceeded to laparotomy 11.
In cases of NEC that were unstable and had been subjected to primary drainage, surprisingly, some of the patients showed a rapid improvement and continued well without the second stage until discharge.
This was in agreement with some retrospective observational case series that documented survival rates that were close to or even much better than those with laparotomy 12.
During this study, neonates with NEC were randomized into two groups irrespective to their clinical, laboratory, or radiological findings. Exclusion criteria were neonates with severe metabolic acidosis and very poor general condition and who could undergo drainage as the only interventional procedure.
However, some researchers believe that the procedure that should be performed in neonates with surgical NEC should be decided on the basis of radiological findings. They assumed that the presence of intestinal pneumatosis indicated extensive involvement of the gut, whereas presence of free air in the peritoneum without intestinal pneumatosis indicated limited involvement of the gut. Therefore, neonates with intestinal pneumatosis require formal laparotomy and patients with free air and with or without a small segment of intestinal pneumatosis might be managed with drainage 13,14.
During analysis of the two groups in this study, no significant differences were found between them in the presence or absence of intestinal pneumatosis.
The overall survival after either procedure in the two groups of this study was insignificant. However, neonates subjected to primary peritoneal drainage showed some improvement over the laparotomy group.
In the same context, Demestre et al.15 reported that 64% of neonates survived after primary peritoneal drainage irrespective of gestational age or birth weight.
In this study, the mean time to initiate oral intake was similar (42 and 44 days, respectively) in both groups; however, neonates who underwent drainage initiated oral intake earlier than those who underwent laparotomy.
Morgan et al. 16 found that neonates treated with immediate laparotomy initiated and achieved full oral intake in 52 days compared with 76 days for neonates subjected to drainage only.
Another important factor related to increased morbidity and mortality in those neonates was the need for ventilatory support either after drainage or after laparotomy.
According to our data, no published works have assessed this factor. Although there was no significant difference in the number of cases requiring respiratory support in the two groups, there was a significant difference in the total duration of ventilation between the two groups.
Dzakovic et al.17 proved that peritoneal drainage improves respiratory functions on ventilation in critically ill neonates with NEC.
We found that peritoneal drainage alone may be an alternative line of management not only in critical ill neonates with low birth weight but also stable neonates who were considered candidates for classic laparotomy.
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Conflicts of interest
There are no conflicts of interest.