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Clinical Trials/NCT04072419
NCT04072419
Unknown
Not Applicable

Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period

Guangzhou Women and Children's Medical Center1 site in 1 country40 target enrollmentSeptember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Atresia
Sponsor
Guangzhou Women and Children's Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Number of participants with post-operative anastomotic leak
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this prospective cohort study is to evaluate the safety and effectiveness of enhanced recovery after surgery (ERAS) to perform routine thoracoscopic repair for elective esophageal atresia type C

Detailed Description

The concept of enhanced recovery after surgery was introduced by Kelhet et al. in the 1990s for colorectal surgery, and it referred to a group of measures performed during a patient's treatment course to improve operative outcomes, reduce complications, and speed up patient recovery. It is now widely applied in many surgical fields, such as thoracic surgery The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), and occurs in approximately 1 in 3500-4500 births. Refinements in surgical technique and perioperative care have dramatically decreased mortality rates of infants with EA/TEF, such that mortality is generally related to associated anomalies. Accordingly, the current focus in optimizing patient outcomes has shifted toward decreasing morbidity, including minimizing postoperative complications, speeding up recovery. One of the milestones in recent years is the introduction and rapid development of video-assisted thoracoscopic surgery (VATS). This surgical method has beneficial effects on patient's post-operative recovery and functional status without compromising surgical resection. A range of operations can now be safely performed via VATS. Although the survival rate of EA is more than 90 percent, there are still many postoperative complications, including anastomotic leakage, recurrence of esophagotracheal fistula, esophageal stenosis, gastroesophageal reflux and other problems, which seriously affect the prognosis. For decades, in order to reduce the complications, post-operative muscle paralysis, mechanical ventilation and urinary catheterization were performed for at least 2 days as convention perioperative management. However, complications after general anesthesia and endotracheal intubation are not negligible, and urinary catheterization is associated with urethral trauma, discomfort, infection. The main reason for placement of chest tube is for post-operative monitoring. However, a chest drain is a recognized cause of post-operative pain and can affect patient's post-operative morbility as well as effective chest physiotherapy. The current project aims to explored the possibility of ERAS approach (i.e. weaning mechanical ventilation after surgery (less than 48h), no post-operative chest tube and urinary catheterization) for specific Type C EA (the distance of blind end is less than 2.5cm, weight\>2.4Kg, without related malformations (heart, kidney, for example), and without structural heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)).

Registry
clinicaltrials.gov
Start Date
September 2019
End Date
December 30, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guangzhou Women and Children's Medical Center
Responsible Party
Principal Investigator
Principal Investigator

He Qiuming

Department of Neonatal Surgery of vice director doctor

Guangzhou Women and Children's Medical Center

Eligibility Criteria

Inclusion Criteria

  • congenital esophageal atresia with type C
  • the distance of blind end is less than 2.5cm
  • weight\>2.4Kg
  • without related malformations (heart, kidney),
  • without structural heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)

Exclusion Criteria

  • Type A/B/D/E esophageal atresia
  • the distance of blind end is more than 2.5cm
  • weight is less than 2.4Kg
  • with Inherited chromosomal related diseases
  • with congenital heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)
  • preoperative severe pneumonia need mechanical ventilation

Outcomes

Primary Outcomes

Number of participants with post-operative anastomotic leak

Time Frame: one month after surgery

Comparison of the morbidity of anastomotic leak between ERAS group and control group, including major and minor leaks

Number of participants with post-operative anastomotic strictures

Time Frame: two years after surgery

Comparison of the morbidity of anastomotic strictures between ERAS group and control. Anastomotic strictures defined as there are symptoms which require intervention.

Number of participants with post-operative recurrent fistula

Time Frame: two years after surgery

Comparison of the morbidity of recurrent fistula between ERAS group and control group

Total number of participants with post-operative complications

Time Frame: two years after surgery

Vocal cord dysfunction, Surgical site infection, Chylothorax, Gastroesophageal reflux, pleural effusion and other complications

Secondary Outcomes

  • length of stay(up to 24 weeks)
  • Length of nutritional support in hospital(up to 24 weeks)

Study Sites (1)

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