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Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

NCT04912453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

PROCEDURE

Primary anastomosis

At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis

PROCEDURE

Enterostomy

At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Kenneth KY Wong, MD, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912453 on ClinicalTrials.gov