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

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

Study Overview

• Status: Unknown
• Conditions: Enhanced Recovery After Surgery; Esophageal Atresia

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)).

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Qiuming He, Doctor; Phone Number: 020-38076288; Email: qiuminghe@foxmail.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Guangzhou Women and Children's Medical Cente
    • Contact: Qiuming He, Doctor; Phone Number: 020-38076288
    • Principal Investigator: Qiuming He, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes congenital esophageal atresia with type C present to Guangzhou Women and Children's Medical Center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
enhanced recovery after surgery group; weaning mechanical ventilation after surgery (less than 48h),; no post-operative chest tube and urinary catheterization); Establishment of early feeding (D3 post-operative)
control group; the time of mechanical ventilation after surgery is more than 48 hours; routine postoperative indwelling chest tube and urinary catheterization); Establishment of feeding after D3 post-operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	length of hospital stay	up to 24 weeks
Length of nutritional support in hospital	Length of nutritional support in hospital	up to 24 weeks

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 31, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: enhanced recovery after surgery; esophageal atresia; perioperative management
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Esophageal Diseases; Digestive System Abnormalities; Esophageal Atresia
• Other Study ID Numbers: GuangzhouWCMC123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No