Comparing two surgical methods for treating severe necrotizing enterocolitis in newborns
A Randomised Controlled Trial to Compare Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis
This study is testing which of two surgical methods works better for treating severe necrotizing enterocolitis in newborns to help them recover and survive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | N/A to 30 Days |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04912453 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two surgical approaches for treating necrotizing enterocolitis (NEC) in neonates: primary anastomosis and enterostomy. NEC is a serious condition affecting premature infants, often requiring surgical intervention when medical treatments fail. The study aims to determine which surgical method leads to better outcomes for infants with severe NEC, particularly those with bowel perforation or necrosis. By comparing these two techniques, the trial seeks to enhance surgical practices and improve survival rates for affected newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates diagnosed with necrotizing enterocolitis who require surgical intervention.
Not a fit: Patients with total necrotizing enterocolitis deemed unsalvageable or those with multiple gangrenous bowel sites requiring extensive surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for infants suffering from severe necrotizing enterocolitis.
How similar studies have performed: While the traditional approach has been well-established, the use of primary anastomosis in this context is less common and may represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All neonates with confirmed NEC and require surgical intervention will be included Exclusion Criteria: 1. Neonates found to have NEC totalis and deemed unsalvageable; 2. Neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses; 3. 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; 4. Parents who do not agree to participate in the study 5. Neonates found to have pathology other than NEC after recruitment (either on intraoperative findings or pathological findings on surgical specimens).
Where this trial is running
Hong Kong
- Department of Surgery, University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Kenneth KY Wong, MD, PhD — The University of Hong Kong
- Study coordinator: Adrian Fung, MBBS
- Email: fungchiheng@gmail.com
- Phone: +85222554850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.