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COMPARING TWO DIFFERENT SURGICAL TECHNIQUES OF FONTAN SURGERY

COMPARISON OF PLEURAL EFFUSION BETWEEN FENESTRATED AND NON-FENESTRATED FONTAN-A PROSPECTIVE RANDOMIZED STUDY

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/015971
Enrollment
40
Registered
2018-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I379- Nonrheumatic pulmonary valve disorder, unspecified

Interventions

Intervention1: FENESTRATION: FENESTRATION IS A TECHNIQUE TO REDUCE INCIDENCE OF PLEURAL EFFUSSION IN PTS UNDERGOING SURGEY FOR UNIVENTRICULAR PHYSIOLOGY Control Intervention1: NON-FENESTRATED FONTAN:

Sponsors

Dr Sachin Talwar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with univentricular physiology . 2. Fit to undergo Extracardiac fontan procedure. 3.Good sized and confluent pulmonary arteries with McGoon ratio >1.5 4.Good ventricular function. 5.Low risk for Fontan surgery.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing emergency Fontan surgery. 2. Parents/guardians not willing to give consent to participate in this study.

Design outcomes

Primary

MeasureTime frame
Duration (more than two weeks) and amount of pleural drainage more than 5 ml per kg on any day ) following Fontan procedure in patients undergoing fenestration compared to non-fenestration groupTimepoint: UPTO 30 DAYS POST OPERATIVELY

Secondary

MeasureTime frame
Hospital stay, time to removal of chest tubes, readmissions and reinsertions of chest tube within 1 month following Fontan procedure and to identify risk factors for increased duration and amount of pleural drainage inpatients with fenestration compared to non-fenestrated patients.Timepoint: UPTO 30 DAYS POST OPERATIVELY

Countries

India

Contacts

Public ContactP Adarsh

AIIMS

sachintalwar@hotmail.com9868398136

Outcome results

None listed

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