Status:
RECRUITING
Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis
Lead Sponsor:
The University of Hong Kong
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief 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 premat...
Eligibility Criteria
Inclusion
- All neonates with confirmed NEC and require surgical intervention will be included
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04912453
Start Date
July 1 2021
End Date
December 31 2025
Last Update
December 11 2024
Active Locations (1)
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1
Department of Surgery, University of Hong Kong
Hong Kong, Hong Kong, 0000