Comparison of efficacy of proximal to anastomosis T-tube enterostomy versus conventional end to end anastomosis in neonates with intestinal atresia

Clinical trial of comparison of effectiveness of proximal to anastomosis T-tube enterostomy versus conventional end to end anastomosis in treatment of neonates with intestinal atresia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180811040765N1

Enrollment

Registered

2018-08-17

Start date

2018-08-06

Completion date

Unknown

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Atresia. Congenital absence, atresia and stenosis of small intestine

Interventions

Intervention 1: Intervention group: Primary end-to-end anastomosis with T-tube application. Intervention 2: Control group: Only primary end-to-end anastomosis.

Eligibility

Sex/Gender

All

Age

1 Days to 20 Days

Inclusion criteria

Inclusion criteria: Neonates with primary diagnosis of intestinal atresia according to the clinical signs and radiographic assessment

Exclusion criteria

Exclusion criteria: Diagnosis of a complication than atresia after initial evaluations

Design outcomes

Primary

Measure	Time frame
Interval between surgery and beginning of oral nutrition. Timepoint: The first day of neonatal oral tolerance. Method of measurement: Daily examinations.;Rate of anastomotic leak. Timepoint: During hospitalization stay. Method of measurement: Sonographic diagnosis.;Rate of anastomotic stricture. Timepoint: During hospitalization stay. Method of measurement: Imaging findings.;Peritonitis rate after surgery. Timepoint: Daily examinations and evaluations. Method of measurement: Clinical signs and blood test.;Duration of improvement of T-tube placement. Timepoint: On the 3, 5, 7 and 14 days after discharge. Method of measurement: Outpatient examination.	—

Measure

Time frame

Interval between surgery and beginning of oral nutrition. Timepoint: The first day of neonatal oral tolerance. Method of measurement: Daily examinations.;Rate of anastomotic leak. Timepoint: During hospitalization stay. Method of measurement: Sonographic diagnosis.;Rate of anastomotic stricture. Timepoint: During hospitalization stay. Method of measurement: Imaging findings.;Peritonitis rate after surgery. Timepoint: Daily examinations and evaluations. Method of measurement: Clinical signs and blood test.;Duration of improvement of T-tube placement. Timepoint: On the 3, 5, 7 and 14 days after discharge. Method of measurement: Outpatient examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoda Ilkhani Pak

Ahvaz University of Medical Sciences

ilkhanipakhoda@gmail.cim+98 61329235893

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026