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

NCT04072419 | Unknown DMC

• 1 other identifier: GuangzhouWCMC123
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Atresia; Enhanced Recovery After Surgery

Keywords

esophageal atresia; enhanced recovery after surgery; perioperative management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• length of stay

  up to 24 weeks

• Length of nutritional support in hospital

  up to 24 weeks

Study Arms (2)

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)

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

Eligibility Criteria

• Age: 1 Hour - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women and Children's Medical Cente

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Qiuming He, Doctor

CONTACT

020-38076288; qiuminghe@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neonatal Surgery of vice director doctor

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

CN (1)