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

NCT ID: NCT04072419

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2022-12-30

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)).

Conditions

Esophageal Atresia; Enhanced Recovery After Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

enhanced recovery after surgery group

1. weaning mechanical ventilation after surgery (less than 48h),

2. no post-operative chest tube and urinary catheterization)

3. Establishment of early feeding (D3 post-operative)

No interventions assigned to this group

control group

1. the time of mechanical ventilation after surgery is more than 48 hours

2. routine postoperative indwelling chest tube and urinary catheterization)

3. Establishment of feeding after D3 post-operative

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

He Qiuming

Department of Neonatal Surgery of vice director doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Women and Children's Medical Cente

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiuming He, Doctor

Role: CONTACT

qiuminghe@foxmail.com

020-38076288

Facility Contacts

Qiuming He, Doctor

Role: primary

020-38076288

Other Identifiers

GuangzhouWCMC123

Identifier Type: -

Identifier Source: org_study_id