An interventional study of Primary anastomosis and Enterostomy in Necrotizing Enterocolitis, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
217 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 90 is below the median of 117 across 117 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: Primary anastomosis
Procedure: Enterostomy
At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis
At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy
Re-operation rate of the two surgical approaches
Time frame: 6 months
Wound-related problems
Wound problems not requiring re-operations e.g. wound infection; stomal prolapse; incisional hernia
Time frame: 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
Time frame: 6 months
Started Jul 2021 (actual). Primary completion is estimated for Jun 2025, 47 months after the start.
Of 34 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 59. This study's planned 47 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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