Azygos Vein Preservation Versus DisconnectionEArAzygousvpNCT05957562
Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair
A study testing EA/TOF primary repair with Azygos vein preservation and EA/TOF primary repair with Azygos vein sacrifice (disconnection) in people with Azygos Vein Preservation Versus Disconnection and Tracheo-Esophageal Fistula With Atresia of Esophagus, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.
Trial summary
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus, Leak, Anastomotic
- What is being tested?
- EA/TOF primary repair with Azygos vein preservation and EA/TOF primary repair with Azygos vein sacrifice (disconnection)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2020to 9 Apr 2023
- Phase
- Interventional
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all neonates suitable for primary repair of Esophageal Atresia and tracheoesophageal fistula
Who cannot join
- long gap esophageal atresia (> 3 cm)
- esophageal atresia without tracheoesophageal fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.
Read the detailed description
Since the first successful repair of esophageal atresia/tracheoesophageal fistula was performed approximately eight decades ago, surgeons have made considerable technical advances in solving intraoperative surgical challenges and reducing postoperative complications. According to some surgeons, the advantage of maintaining the Azygos vein makes this modification attractive. This study aimed to explore the benefits of retaining the Azygos vein during surgery for Esophageal Atresia with tracheoesophageal fistula, to emphasize its advantages in terms of reducing anastomotic leak, stricture, and other postoperative outcomes.
Patients and Methods: This prospective randomized study was conducted between April 2020 and April 2023. The study included all newborns with (EA \& TEF) eligible for primary repair, patients were randomly assigned to either Group A or Group B. (Group A) patients who underwent Azygos vein preservation during TEF repair, whereas the remaining patients (Group B) had Azygos vein disconnection.
Statistical analysis: The Statistical Package for Social Sciences (SPSS) (version 23.0, IBM Corp IBM Corp., Armonk, NY, USA) was used for statistical analysis. The chi-square test (X2) was used to compare qualitative data in the groups, while an independent-sample t-test was used to compare quantitative data between groups. The degree of confidence was set at 95%. The p-value was considered significant at a level of 0.05.
Discussion: will focus on advantages of azygous vein preservation on intactness of esophageal anastomosis, retaining the venous drainage of the bronchial system, and chest wall. Points of discussion will include effects of Azygous vein preservation on incidence of postoperative pneumonitis, anastomotic leakage and stricture rate, and mortality rate. The results obtained from this study will be compared between both groups and with those reported in the literature.
Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
- Conditions
- Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus, Leak, Anastomotic, Stricture Esophagus, Pneumonitis; Postoperative
- Being tested
- EA/TOF primary repair with Azygos vein preservation, EA/TOF primary repair with Azygos vein sacrifice (disconnection)
- Keywords
- Esophageal Atresia,, Tracheoesophageal fistula,, Preservation of the Azygos vein,, Division of Azygos vein,, Pediatrics
- Medical subject headings
- Esophageal atresia with or without tracheoesophageal fistula, Anastomotic Leak, Esophageal Stenosis, Pneumonia, Esophageal Atresia, Tracheoesophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA/TOF primary repair with Azygos vein preservationProcedure or surgery
primary repair of EA/TOF with either azygous vein preservation or disconnection (to assess the effects and expected benefits of the former technique on viability of the repair and decrease of postoperative early complications and mortality rate)
EA/TOF primary repair with Azygos vein sacrifice (disconnection)Procedure or surgery
primary repair of EA/TOF with either azygous vein preservation or disconnection (to assess the effects and expected benefits of the former technique on viability of the repair and decrease of postoperative early complications and mortality rate)
| Study group | Role | What they receive |
|---|---|---|
| EA/TOF primary repair with Azygos vein preservation | Active comparator | primary esophagoesophagostomy with azygous vein preservation technique and will be done for 32 neonates with EA/TOF amenable for primary repair Receives: Procedure: EA/TOF primary repair with Azygos vein preservation |
| EA/TOF primary repair with Azygos vein sacrifice (disconnection) | Active comparator | primary esophagoesophagostomy with azygous vein disconnection ordinary technique and will be done for 32 neonates with EA/TOF suitable for primary repair Receives: Procedure: EA/TOF primary repair with Azygos vein sacrifice (disconnection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gap between the pouches after mobilization
missed distance between the mobilized esophageal pouches in centimeters
Measured: 2 years
operative time
operative time in minutes
Measured: 2 years
early postoperative pneumonia
postoperative pneumonitis in number
Measured: 35 months
early postoperative anastomotic leak
anastomotic leakage rate in number
Measured: 35 months
early postoperative anastomotic stricture
anastomotic stricture rate in number
Measured: 35 months
mortality
mortality rate in number
Measured: 35 months
Secondary outcomes (4)
gestational age
gestational age in weeks
Measured: 2 years
sex
patient's gender in number
Measured: 2 years
associated congenital anomalies
associated congenital anomalies in number
Measured: 2 years
associated anomalies
associated congenital anomalies in percentage of cases
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start10 Apr 2020
- Primary completion6 Oct 2022
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azygos Vein Preservation Versus DisconnectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled study conducted to assess the technical feasibility and surgical outcomes of one stage surgical repair, either with Azygos vein preservation or with Azygous vein disconnection, in newborns diagnosed with Esophageal Atresia and tracheoesophageal fistula. It includes 64 neonates with TOF/EA who will be randomly divided (using the sealed closed envelope method) into two equal groups, each group will include 34 neonatal patients
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Muhammad Abdelhafez Mahmoud, MD, Al-Azhar University
- Investigators
- Ahmed Elshamy, MD, Study chair, Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957562
- Sponsor's protocol ID
- AlAzharEArepairAzygouspreserve
- Acronym
- EArAzygousvp
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during the current study are available from the corresponding author but could not be sent owing to the medicolegal aspect of the hospital policy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05957562
- Acronym / sponsor ID
- EArAzygousvp / AlAzharEArepairAzygouspreserve
- Conditions
- Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus, Leak, Anastomotic, Stricture Esophagus, Pneumonitis; Postoperative
- Keywords
- Esophageal Atresia,, Tracheoesophageal fistula,, Preservation of the Azygos vein,, Division of Azygos vein,, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 24 Jul 2023 (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.
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.
Detailed description
Since the first successful repair of esophageal atresia/tracheoesophageal fistula was performed approximately eight decades ago, surgeons have made considerable technical advances in solving intraoperative surgical challenges and reducing postoperative complications. According to some surgeons, the advantage of maintaining the Azygos vein makes this modification attractive. This study aimed to explore the benefits of retaining the Azygos vein during surgery for Esophageal Atresia with tracheoesophageal fistula, to emphasize its advantages in terms of reducing anastomotic leak, stricture, and other postoperative outcomes.
Patients and Methods: This prospective randomized study was conducted between April 2020 and April 2023. The study included all newborns with (EA \& TEF) eligible for primary repair, patients were randomly assigned to either Group A or Group B. (Group A) patients who underwent Azygos vein preservation during TEF repair, whereas the remaining patients (Group B) had Azygos vein disconnection.
Statistical analysis: The Statistical Package for Social Sciences (SPSS) (version 23.0, IBM Corp IBM Corp., Armonk, NY, USA) was used for statistical analysis. The chi-square test (X2) was used to compare qualitative data in the groups, while an independent-sample t-test was used to compare quantitative data between groups. The degree of confidence was set at 95%. The p-value was considered significant at a level of 0.05.
Discussion: will focus on advantages of azygous vein preservation on intactness of esophageal anastomosis, retaining the venous drainage of the bronchial system, and chest wall. Points of discussion will include effects of Azygous vein preservation on incidence of postoperative pneumonitis, anastomotic leakage and stricture rate, and mortality rate. The results obtained from this study will be compared between both groups and with those reported in the literature.
Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This randomized controlled study conducted to assess the technical feasibility and surgical outcomes of one stage surgical repair, either with Azygos vein preservation or with Azygous vein disconnection, in newborns diagnosed with Esophageal Atresia and tracheoesophageal fistula. It includes 64 neonates with TOF/EA who will be randomly divided (using the sealed closed envelope method) into two equal groups, each group will include 34 neonatal patients
| Arm | Type | Receives |
|---|---|---|
| EA/TOF primary repair with Azygos vein preservation | Active comparator | Procedure: EA/TOF primary repair with Azygos vein preservationprimary esophagoesophagostomy with azygous vein preservation technique and will be done for 32 neonates with EA/TOF amenable for primary repair |
| EA/TOF primary repair with Azygos vein sacrifice (disconnection) | Active comparator | Procedure: EA/TOF primary repair with Azygos vein sacrifice (disconnection)primary esophagoesophagostomy with azygous vein disconnection ordinary technique and will be done for 32 neonates with EA/TOF suitable for primary repair |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all neonates suitable for primary repair of Esophageal Atresia and tracheoesophageal fistula
Key exclusion criteria (2 listed)
- long gap esophageal atresia (> 3 cm)
- esophageal atresia without tracheoesophageal fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EA/TOF primary repair with Azygos vein preservationprimary repair of EA/TOF with either azygous vein preservation or disconnection (to assess the effects and expected benefits of the former technique on viability of the repair and decrease of postoperative early complications and mortality rate) | Procedure or surgery | EA/TOF primary repair with Azygos vein preservation |
| EA/TOF primary repair with Azygos vein sacrifice (disconnection)primary repair of EA/TOF with either azygous vein preservation or disconnection (to assess the effects and expected benefits of the former technique on viability of the repair and decrease of postoperative early complications and mortality rate) | Procedure or surgery | EA/TOF primary repair with Azygos vein sacrifice (disconnection) |
Primary outcome
gap between the pouches after mobilization
Time frame: 2 years
missed distance between the mobilized esophageal pouches in centimeters
operative time
Time frame: 2 years
operative time in minutes
early postoperative pneumonia
Time frame: 35 months
postoperative pneumonitis in number
early postoperative anastomotic leak
Time frame: 35 months
anastomotic leakage rate in number
early postoperative anastomotic stricture
Time frame: 35 months
anastomotic stricture rate in number
mortality
Time frame: 35 months
mortality rate in number
4 secondary outcomes
gestational age
Time frame: 2 years
sex
Time frame: 2 years
associated congenital anomalies
Time frame: 2 years
associated anomalies
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during the current study are available from the corresponding author but could not be sent owing to the medicolegal aspect of the hospital policy.
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.
Ahmed Elshamy, MD study chair
Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA/TOF primary repair with Azygos vein preservation and EA/TOF primary repair with Azygos vein sacrifice (disconnection) in people with Azygos Vein Preservation Versus Disconnection and Tracheo-Esophageal Fistula With Atresia of Esophagus, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jul 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gap between the pouches after mobilization (time frame: 2 years). The study lists 6 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 24 Jul 2023.