Primary Anastomosis Versus Enterostomy in the Surgical Treatment of

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04912453
Study type	Interventional
Source	The University of Hong Kong
Contact	Adrian Fung, MBBS
Phone	+85222554850
Email	fungchiheng@gmail.com
Status	Recruiting
Phase	N/A
Start date	July 1, 2021
Completion date	January 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05544097` - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis	N/A
Recruiting	`NCT03210831` - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Recruiting	`NCT02552706` - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis	N/A
Completed	`NCT02400697` - Placental Transfusion Project for Preterm Infants	N/A
Completed	`NCT01751477` - Infloran® for Prevention of Necrotizing Enterocolitis	N/A
Terminated	`NCT01156480` - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Recruiting	`NCT01441739` - Intestinal Failure in Necrotising Enterocolitis	N/A
Recruiting	`NCT04074824` - A Genome-Wide Association Study for Neonatal Diseases
Recruiting	`NCT03869827` - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Terminated	`NCT03320785` - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting	`NCT03554278` - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting	`NCT04541771` - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants	Phase 2
Not yet recruiting	`NCT03700957` - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed	`NCT01745510` - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates	Phase 1/Phase 2
Completed	`NCT01735578` - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis	N/A
Unknown status	`NCT01807858` - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms