Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Study Overview
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Brief Summary
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Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. It is estimated that up to 10% of premature babies can suffer from this condition. Despite aggressive medical treatment, surgical intervention is necessary in up half of the cases for bowel necrosis or perforation and these often represent the more severe form of the disease. The advances in neonatal intensive care and surgical knowledge have resulted in improved survival rate in recent years. For NEC patients with severe disease (i.e.) those with intestinal perforation or gangrenous bowel not responding to medical therapy, surgery with resection of diseased segments is the treatment of choice. Traditional surgical approach would be to resect the diseased bowel segment with formation of enterostomy. However, in a few advanced centres, primary anastomosis after the resection of diseased bowel segment is practised. Retrospective reports of the primary anastomosis approach have shown that this is also a viable option with no increased rate of peri-operative morbidity. It also has the advantage of avoiding a second operation for enterostomy closure. Nonetheless, prospective studies comparing the two approaches are lacking. The proposed study will fill up the following knowledge gap on what the best surgical option for NEC at laparotomy is. The findings will help guide our practice for NEC patients in the future in order to provide them with the best possible and evidence-based care. In this study, the investigators hypothesize that neonates with major NEC undergoing primary anastomosis after surgical resection is not inferior to neonates who have enterostomy, in terms of peri-operative morbidities. Aim of the study is to compare the short term and medium term outcomes of NEC patients requiring surgical intervention who either receive primary anastomosis or enterostomy creation.

Official Title
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A Randomised Controlled Trial to Compare Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Procedure: Primary anastomosis
* Procedure: Enterostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All neonates with confirmed NEC and require surgical intervention will be included Exclusion Criteria: Neonates found to have NEC totalis and deemed unsalvageable; Neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses; Neonates found to be extremely unstable cardiovascularly intra-operatively and can only withstand excision of gangrenous bowels, but will not allow anastomosis or stoma creation; Parents who do not agree to participate in the study Neonates found to have pathology other than NEC after recruitment (either on intraoperative findings or pathological findings on surgical specimens).

Ages Eligible for Study
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Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All neonates with confirmed NEC and require surgical intervention will be included. This is a local multi-centre study and neonates from the three centres which perform neonatal surgery will participate. At laparotomy, the diseased segment of intestine will be resected and the patients will then receive either primary anastomosis or enterostomy according to randomisation done pre-operatively.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary anastomosis group<br> | Procedure: Primary anastomosis<br>* At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis<br>|
| Experimental: Enterostomy group<br> | Procedure: Enterostomy<br>* At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation rate of the two surgical approaches |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound-related problems | Wound problems not requiring re-operations e.g. wound infection; stomal prolapse; incisional hernia | 6 months | 
| Time to full enteral feeding | Time needed (in term of days) to achieve full enteral feeding (defined as 150ml/kg/day) and stoppage of parenteral feeding | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing Enterocolitis, Neonatal surgery, Primary anastomosis, Enterostomy