Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

A Randomised Controlled Trial to Compare Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912453
• Other study ID #: NECHKTrial
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Adrian Fung, MBBS
• Phone: +85222554850
• Email: fungchiheng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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).

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Procedure:
• Primary anastomosis
At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis
• Enterostomy
At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-operation rate of the two surgical approaches		6 months
Secondary	Wound-related problems	Wound problems not requiring re-operations e.g. wound infection; stomal prolapse; incisional hernia	6 months
Secondary	Time to full enteral feeding	Time needed (in term of days) to achieve full enteral feeding (defined as 150ml/kg/day) and stoppage of parenteral feeding	6 months