Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

NCT04912453 | Recruiting

• 1 other identifier: NECHKTrial
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Re-operation rate of the two surgical approaches

  6 months

Secondary Outcomes (2)

• Wound-related problems

  6 months

• Time to full enteral feeding

  6 months

Study Arms (2)

Primary anastomosis group

EXPERIMENTAL

Procedure: Primary anastomosis

Enterostomy group

EXPERIMENTAL

Procedure: Enterostomy

Interventions

Primary anastomosis PROCEDURE

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

Primary anastomosis group

Enterostomy PROCEDURE

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

Enterostomy group

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All neonates with confirmed NEC and require surgical intervention will be included

You may not qualify if:

• Neonates found to have NEC totalis and deemed unsalvageable;
• Neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses;
• 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;
• Parents who do not agree to participate in the study
• Neonates found to have pathology other than NEC after recruitment (either on intraoperative findings or pathological findings on surgical specimens).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Surgery, University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Enterostomy

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Kenneth KY Wong, MD, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Fung, MBBS

CONTACT

+85222554850; fungchiheng@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All neonates with confirmed NEC and require surgical intervention will be included. This is a local multi-centre study and neonates from the three centres which perform neonatal surgery will participate. At laparotomy, the diseased segment of intestine will be resected and the patients will then receive either primary anastomosis or enterostomy according to randomisation done pre-operatively.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-05

Locations

HK (1)