Esophageal AtresiaERASforCEANCT04072419
Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period
An observational study of Esophageal Atresia and Enhanced Recovery After Surgery, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Esophageal Atresia, Enhanced Recovery After Surgery
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes congenital esophageal atresia with type C present to Guangzhou Women and Children's Medical Center
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Cente
Guangzhou
Qiuming He, Doctor, 020-38076288
Qiuming He, Doctor
About this study
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
Read the 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)).
- Keywords
- esophageal atresia, enhanced recovery after surgery, perioperative management
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: two years after surgery
Secondary outcomes (2)
length of stay
length of hospital stay
Measured: up to 24 weeks
Length of nutritional support in hospital
Length of nutritional support in hospital
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startSep 2019 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Qiuming, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072419
- Sponsor's protocol ID
- GuangzhouWCMC123
- Acronym
- ERASforCEA
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period
- ClinicalTrials.gov ID
- NCT04072419
- Acronym / sponsor ID
- ERASforCEA / GuangzhouWCMC123
- Keywords
- esophageal atresia, enhanced recovery after surgery, perioperative management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes congenital esophageal atresia with type C present to Guangzhou Women and Children's Medical Center
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 recurrent fistula
Time frame: two years after surgery
Comparison of the morbidity of recurrent fistula between ERAS group and control group
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.
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
2 secondary outcomes
length of stay
Time frame: up to 24 weeks
Length of nutritional support in hospital
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia and Enhanced Recovery After Surgery, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiuming He, Doctor (020-38076288, qiuminghe@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with post-operative anastomotic leak (time frame: one month after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.