Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Procedure: Primary anastomosis; Procedure: Enterostomy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian Fung, MBBS; Phone Number: +85222554850; Email: fungchiheng@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Recruiting
    • Department of Surgery, University of Hong Kong
    • Contact: Adrian Fung, MBBS; Phone Number: +85222554850; Email: fungchiheng@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary anastomosis group	Procedure: Primary anastomosis; At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis
Experimental: Enterostomy group	Procedure: Enterostomy; At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Re-operation rate of the two surgical approaches	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound-related problems	Wound problems not requiring re-operations e.g. wound infection; stomal prolapse; incisional hernia	6 months
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Kenneth KY Wong, MD, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Necrotizing Enterocolitis; Neonatal surgery; Enterostomy; Primary anastomosis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: NECHKTrial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No