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

Enhanced Recovery After Surgery Clinical Trial

— ERASforCEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04072419
• Other study ID #: GuangzhouWCMC123
• Status: Recruiting
• Start date: September 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2019
• Source: Guangzhou Women and Children's Medical Center
• Contact: Qiuming He, Doctor
• Phone: 020-38076288
• Email: qiuminghe[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

1. congenital esophageal atresia with type C

2. the distance of blind end is less than 2.5cm

3. weight>2.4Kg

4. without related malformations (heart, kidney),

5. without structural heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)

Exclusion Criteria:

1. Type A/B/D/E esophageal atresia

2. the distance of blind end is more than 2.5cm

3. weight is less than 2.4Kg

4. with Inherited chromosomal related diseases

5. with congenital heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)

6. preoperative severe pneumonia need mechanical ventilation

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Esophageal Atresia

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Cente	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with post-operative anastomotic leak	Comparison of the morbidity of anastomotic leak between ERAS group and control group, including major and minor leaks	one month after surgery
Primary	Number of participants with post-operative recurrent fistula	Comparison of the morbidity of recurrent fistula between ERAS group and control group	two years after surgery
Primary	Number of participants with post-operative anastomotic strictures	Comparison of the morbidity of anastomotic strictures between ERAS group and control. Anastomotic strictures defined as there are symptoms which require intervention.	two years after surgery
Primary	Total number of participants with post-operative complications	Vocal cord dysfunction, Surgical site infection, Chylothorax, Gastroesophageal reflux, pleural effusion and other complications	two years after surgery
Secondary	length of stay	length of hospital stay	up to 24 weeks
Secondary	Length of nutritional support in hospital	Length of nutritional support in hospital	up to 24 weeks