Primary posterior tracheopexy prevents tracheal collapse
Research type
Research Study
Full title
Primary pOsterioR TRacheopexy prevents collapse of the trachea in newborns with oesophageal AtresIa and Tracheomalacia
IRAS ID
336817
Contact name
Colin Butler
Contact email
Sponsor organisation
University Medical Centre Utrecht, dept Wilhelmina's Children Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
A blind-ending oesophagus, or Oesophageal Atresia (OA), is often accompanied by a weakened windpipe (trachea). This is known as tracheomalacia (TM) and entails that the windpipe collapses during expiration. Severe TM can cause increased respiratory morbidity.
When severe TM is identified, surgical intervention may be necessary. This surgical procedure involves widening the trachea (using sutures) to prevent its collapse, known as posterior tracheopexy (PT). Prior to performing this PT, complications and sequelae of TM may have already manifested. Additionally, performing this PT as a secondary operation after correcting OA is a long, complex procedure in newborns, with a risk of damaging the OA anastomosis. There is a growing trend to carry out the PT concurrently with the initial correction of OA, called a primary posterior tracheopexy (PPT). Previous studies have shown a decrease in respiratory tract infections (RTI’s) and brief respiratory unexplained events (BRUE’s) following the implementation of PPT, compared to patients who did not undergo PPT.
To address several sources of bias, such as center-specific factors, selection-bias and information bias, a double-blind randomised controlled trial should be conducted. The aim of this study is to evaluate if a PPT can significantly decrease – or possibly prevent - the collapse of the trachea in newborns with OA and TM. Additionally, the study aims to determine whether the observed effect of PPT on tracheal stability is sustained over time. In order to evaluate this, randomisation will be carried out between performing a PPT or no-PPT. To accurately evaluate the effects of PPT versus no-PPT (i.e. the tracheal diameter) a bronchoscopy needs to be performed, as it is the only objective measure for this purpose. Bronchoscopy allows for a direct visual examination of the trachea, ensuring a reliable and unbiased evaluation of the impact of PPT on the tracheal diameter.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0080
Date of REC Opinion
28 Aug 2024
REC opinion
Further Information Favourable Opinion