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The difference in the effect of Botulinum Toxin injection combined with the Foker technique versus anastomosis in long-gap esophageal atresia

Evaluation of the Effect of Botulinum Toxin Type A Injections Combined with Foker Technique on Primary Anastomosis Repair in Neonates with Long-Gap Esophageal Atresia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180310039030N2
Enrollment
10
Registered
2025-09-30
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Long-Gap Esophageal Atresia. Atresia of esophagus without fistula

Interventions

Intervention 1: Intervention group: Our working method in the intervention group is Fokker's method: After birth and diagnosis of long-gap esophageal atresia, the first stage of the Fokker method is p

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to No maximum

Inclusion criteria

Inclusion criteria: Newborn infants diagnosed with long-gap esophageal atresia Absence of other serious anomalies that require immediate surgery

Exclusion criteria

Exclusion criteria: Presence of other congenital malformations, such as major cardiac anomalies requiring immediate surgical interventions, or cases where the patient is deemed unsuitable for surgery from an anesthetic perspective. Lack of parental consent for participation in the study.

Design outcomes

Primary

MeasureTime frame
Esophageal Length. Timepoint: before surgery, 6 days after surgery, and during follow-up at 3 and 6 months. Method of measurement: Measurement using imaging techniques.;Anastomotic Stricture Formation. Timepoint: 1, 3, and 6 months after surgery. Method of measurement: Assessment using endoscopy and radiography.;Anastomotic Leak. Timepoint: 1 and 3 months after surgery. Method of measurement: Assessment using imaging studies.

Secondary

MeasureTime frame
Hospital Length of Stay. Timepoint: duration of hospitalization. Method of measurement: Measurement of the duration of hospitalization (days).;Postoperative Complications. Timepoint: days of post operation. Method of measurement: Assessment of complications such as infections and respiratory issues after surgery.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactkhashayar Atqiaee

Mashhad University of Medical Sciences

khashayar_atqiaee@sbmu.ac.ir+98 51 3871 3801

Outcome results

None listed

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