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Search / Trial NCT04912453

Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Launched by THE UNIVERSITY OF HONG KONG · May 28, 2021

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Necrotizing Enterocolitis Neonatal Surgery Primary Anastomosis Enterostomy

ClinConnect Summary

This clinical trial is studying two different surgical methods for treating a serious condition called necrotizing enterocolitis (NEC) in premature infants. NEC affects the intestines and can be life-threatening, often requiring surgery when medical treatments aren't enough. The two methods being compared are primary anastomosis, where the healthy ends of the intestine are directly connected after removing the diseased part, and enterostomy, where an opening is created in the abdomen for waste to exit. The goal is to determine which approach leads to better recovery in the short and medium term for babies needing surgery.

To be eligible for this study, infants must have a confirmed diagnosis of NEC and require surgical intervention. However, those who are too unstable for surgery or have other serious conditions will not be included. If your child participates, they will receive one of the two surgical treatments, and the doctors will closely monitor their recovery and health outcomes. This research aims to improve surgical care for infants with NEC, ultimately helping doctors make the best choices for these vulnerable patients in the future.

Gender

ALL

Eligibility 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).

About The University Of Hong Kong

The University of Hong Kong (HKU) is a leading research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, HKU collaborates with various stakeholders, including healthcare providers and industry partners, to conduct rigorous and ethically sound clinical studies. The university's diverse expertise and state-of-the-art facilities enable it to explore a wide range of therapeutic areas, contributing to the global pursuit of scientific advancement and the development of novel treatment strategies.

Locations

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Trial Officials

Kenneth KY Wong, MD, PhD

Principal Investigator

The University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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