STAT Trial: Stoma or Intestinal Anastomosis for Necrotizing Enterocolitis of the Neonate: Multicentre Randomized Controlled Trial

Recruiting

• Conditions: necrotizing enterocolitis; 10017966; 10017998

• Registration Number: NL-OMON34083
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Suspected NEC
2. Need for laparotomy based on:
2.1. Radiological signs of intestinal perforation or
2.2. Failure of improvement with medical treatment
3. Aged 0 - 6 months, either sex

Exclusion Criteria

1. No evidence of NEC (e.g. intestinal volvulus)
2. Focal intestinal perforation (since many surgeons would not perform a stoma)
3. Extensive NEC precluding intestinal anastomosis (intestinal resection will result in short bowel)
4. NEC affecting the colon that cannot be completely assessed because of risk of bleeding
5. Patient's instability during the operation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point of the study will be duration of parenteral nutrition<br /><br>(days), as this reflects the recovery of intestinal function after NEC and will<br /><br>be affected by complications and/or need for further procedures.</p><br>