Peritoneal drainage versus laparotomy as initial treatment for surgical necrotising enterocolitis or spontaneous intestinal perforation in preterm very low birth weight infants.

RATIONALE

Laparotomy and peritoneal drainage are two options for managing preterm very low birth weight infants with surgical necrotising enterocolitis (NEC) or spontaneous intestinal perforation (SIP). Peritoneal drainage has the theoretical benefit of avoiding surgery, whereas laparotomy enables the surgeon to directly visualise the intestines and undertake appropriate interventions. There is debate as to which method is superior. This is an update of a Cochrane review first published in 2011.

OBJECTIVES

To evaluate the benefits and harms of peritoneal drainage compared to laparotomy as the initial treatment for surgical NEC or SIP in preterm very low birth weight infants.

SEARCH METHODS

We searched CENTRAL, MEDLINE, Embase, CINAHL, and two trial registries, together with reference checking, citation searching, and contact with study authors to identify the studies that are included in the review. The latest search date was December 2024.

ELIGIBILITY CRITERIA

We included all randomised controlled trials (RCTs) or quasi-RCTs in preterm (< 37 weeks gestation) infants with very low birth weight (< 1500 g) with surgical NEC or SIP allocated to peritoneal drainage or laparotomy as initial surgical treatment. Intestinal perforations due to other causes were excluded.

OUTCOMES

The main outcomes of interest were mortality or neurodevelopmental impairment (NDI) at 18 to 24 months, NDI at 18 to 24 months among survivors, moderate to severe cerebral palsy at 18 to 24 months, mortality before discharge, mortality before 18 to 24 months corrected age, and subsequent laparotomy during initial hospital stay.

RISK OF BIAS

We used the original Cochrane risk of bias tool (RoB 1) to assess bias in the included RCTs.

SYNTHESIS METHODS

We synthesised results for each outcome using meta-analysis, where possible, by calculating risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI) for dichotomous outcomes and continuous outcomes, respectively. Where this was not possible due to the nature of the data, we summarised the results narratively. We used GRADE to assess the certainty of evidence for each outcome.

INCLUDED STUDIES

We included three trials with a total of 496 preterm very low birth weight infants, of which 469 (94.6%) had a birth weight of less than 1000 g. Two trials were conducted in North America. One multi-centre trial was conducted in the UK, Europe, Asia, New Zealand, and Australia. The overall risk of bias in all three included trials was low, but the nature of the intervention meant that parents, caregivers, or clinical investigators were aware of the intervention groups.

SYNTHESIS OF RESULTS

Peritoneal drainage compared to laparotomy Peritoneal drainage likely results in little to no difference in mortality or NDI at 18 to 24 months (RR 1.02, 95% CI 0.88 to 1.19; risk difference (RD) 0.01, 95% CI -0.09 to 0.12; 1 trial, 295 infants; moderate-certainty evidence) and NDI at 18 to 24 months among survivors (RR 1.01, 95% CI 0.79 to 1.29; RD 0.01, 95% CI -0.13 to 0.14; 1 trial, 206 infants; moderate-certainty evidence). Peritoneal drainage likely increases the risk of moderate to severe cerebral palsy (RR 1.69, 95% CI 1.00 to 2.86; RD 0.12, 95% CI 0.00 to 0.23; number needed to treat for an additional harmful outcome (NNTH) 8.3; 1 trial, 210 infants; moderate-certainty evidence). Peritoneal drainage likely results in little to no difference in mortality before discharge (RR 1.12, 95% CI 0.82 to 1.54; RD 0.03, 95% CI -0.06 to 0.12; I = 0%; 2 trials, 378 infants; moderate-certainty evidence) and mortality before 18 to 24 months of age (RR 1.06, 95% CI 0.74 to 1.50; RD 0.02, 95% CI -0.09 to 0.12; 1 trial, 308 infants; moderate-certainty evidence). Infants in the peritoneal drainage group are more likely to need subsequent laparotomy during the first hospital stay (RR 2.26, 95% CI 1.73 to 2.95; RD 0.28, 95% CI 0.20 to 0.36; I = 0%; 3 trials, 492 infants; moderate-certainty evidence).

AUTHORS' CONCLUSIONS: Peritoneal drainage, when compared to laparotomy, likely results in little to no difference in mortality or overall neurodevelopmental outcomes at 18 to 24 months of age, and mortality before initial hospital discharge in preterm very low birth weight infants with surgical NEC or SIP. However, peritoneal drainage likely results in an increase in the risk of moderate to severe cerebral palsy. In addition, infants in the peritoneal drainage group are more likely to need subsequent laparotomy during the first hospital stay. In the absence of any substantial ongoing RCTs, clinicians may have to use the existing evidence to make management decisions.

FUNDING

This Cochrane review had no dedicated funding.

REGISTRATION

Protocol available via doi.org/10.1002/14651858.CD006182. 2011 published review available via doi.org/10.1002/14651858.CD006182.pub2.