Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

NCT ID: NCT04912453

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-12-31

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 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.

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing Enterocolitis; Neonatal surgery; Primary anastomosis; Enterostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary anastomosis group

Group Type: EXPERIMENTAL

Primary anastomosis

Intervention Type: PROCEDURE

At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis

Enterostomy group

Group Type: EXPERIMENTAL

Enterostomy

Intervention Type: PROCEDURE

At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy

Interventions

Primary anastomosis

At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis

Intervention Type: PROCEDURE

Enterostomy

At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy

Intervention Type: PROCEDURE

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).

• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth KY Wong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Department of Surgery, University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Adrian Fung, MBBS

Role: CONTACT

Phone: +85222554850

Email: fungchiheng@gmail.com

Facility Contacts

Adrian Fung, MBBS

Role: primary

Other Identifiers

NECHKTrial

Identifier Type: -

Identifier Source: org_study_id