Congenital Esophageal AtresiaRR VS TR VS ORNCT06208449
Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia
A study testing Robotic repair for EA, Thoracoscopic repair for EA and Thoracotomy repair for EA in people with Congenital Esophageal Atresia, run by Zunyi Medical College at 1 site in China.
Trial summary
Thoracotomy repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Congenital Esophageal Atresia
- What is being tested?
- Robotic repair for EA, Thoracoscopic repair for EA and Thoracotomy repair for EA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 31 Dec 2025
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type C EA neonates with short esophageal gap length (less than 3 vertebral bodies), mini-invasive repair, and a successful one-stage anastomosis were included.
Who cannot join
- Patients with respiratory distress requiring assisted ventilation, long esophageal gap length, multistage surgery, other types EA (type A/B/D/E) or surgical contraindications were excluded.
- Gestational age less than 35 weeks and birth weight less than 2kg were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated hospital of zunyi medical university
Zunyi, Guizhou, 56300
About this study
Official title: Comparison of Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia
Thoracotomy repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient. thoracoscopy repair offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair. Robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair. However, there were no randomized controlled trials to verify the effectiveness of three procedures. The objection was to compare the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.
Read the detailed description
Esophageal atresia (EA) and tracheoesophageal fistula (TEF) is one of the most common congenital malformations of esophagus, with an incidence of 1/2500~1/4500. The condition can be an isolated malformation or may be associated with other congenital anomalies. Since Dr Cameron Height performed the first successful primary repair of a neonate with EA/ TEF in 1941, many advances in surgical technique and neonatal care have steadily improved survival rates of babies within the EA/TEF spectrum. Survival of infants with esophageal atresia has increased over time since the first successful repair and the overall survival exceeds 90%. Commonly, esophageal atresia is repaired via a right posterolateral thoracotomy and more recently muscle sparing thoracotomy has become an alternative to the traditional muscle cutting approach. Open repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient.
The first successful thoracoscopic surgery of a child with EA was reported in 1999. Compared to thoracotomy repair the proposed main advantage of thoracoscopic repair is that it offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair, thoracoscopic repair also offers concerns with more complicated anesthesia, limited workspace, and difficultly controlling the vascular structures. Especially, suturing within such a small, closed space has been considered a major technical difficulty.
Robotic repair was first reported by Meehan in 2009, followed by several case reports. The reported reasons for conversion mainly focused on the incompatibility between the robotic trocar\'s size and the intercostal space\'s width, and the technical challenges due to instrument collisions in the extremely limited thoracoscopic space. The intercostal space of neonates is highly narrow, and the thoracic diameter is only 8 cm. These are the two key technical issues to be addressed in this study. According to the existing robotic system setup standard for adults, the distance required between trocar ports in robots is usually at least 8 cm to ensure sufficient operating space and avoid instrument collisions. Even for the new generation of robots, this minimum distance requires 5-6 cm. Huge robotic trocars used in EA neonates fail to meet the standard for conventional operating port distances. There have study designed an asymmetric port distribution technique in which the third and eighth intercostal ports are 3 cm and 5 cm away from the camera port. The surgeons primarily manipulated the inner-articulating part of the robotic arms within the thoracic cavity, avoiding instrument collisions outside. Moreover, the setup of the trocars ensures that the robotic arms can reach the main operating area. When combined with instruments of 7 degrees of freedom, the mobilization and anastomosis of the esophagus could be completed easily, breaking through the narrow space restriction of thoracic cavity. Inserting 8-12 cm trocars into tiny intercostal space was another technical challenge. The results shown the robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair.
An international survey from 2014 highlighted the need for consensus on the optimal surgical treatment of EA. However, a detailed understanding of whether thoracoscopic repair or robotic repair offers advantages in terms of health outcomes, safety, and efficacy for providers compared to thoracotomy repair is still lacking. Several reviews are opinion-based or obscured by institutional/personal experiences. Herewith, we designed a comprehensive study and focused on evaluating the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.
- Conditions
- Congenital Esophageal Atresia
- Being tested
- Robotic repair for EA, Thoracoscopic repair for EA, Thoracotomy repair for EA
- Keywords
- robotic surgery, thoracoscopy repair, thoracotomy repair, esophageal atresia, efficacy, complications
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic repair for EAProcedure or surgery
The paitents with EA were repaired by Da Vinci robot
Thoracoscopic repair for EAProcedure or surgery
The patients with EA were repaired by thoracoscopy
Thoracotomy repair for EAProcedure or surgery
The patients with EA were repaired by traditional open thoracotomy.
| Study group | Role | What they receive |
|---|---|---|
| Robotic repair group | Experimental | 1. the patients were lying in a left decubitus position (45° prone).
2. An 8-mm trocar was inserted into the thoracic cavity at the fifth intercostal space of the right midaxillary line and used as a camera port, Another two 8-mm trocars were placed at the third intercostal space of the right midaxillary line and the eighth intercostal space of the posterior axillary line. Insufflation of the CO2 was at a flow rate of 1 L/min and a pressure of 6 mm Hg.
3. The fistula was ligated and sutured by figure-of-eight suture ligation. The proximal blind end was fully mobilized and the distal blind end was properly mobilized to prepare for anastomosis.
4. Next, the 5-0 absorbable sutures were used to perform the anastomosis posteriorly and anteriorly in an interrupted way.. Thereafter, the nasogastric tube was inserted into the stomach. followed by another 6 sutures to complete the anterior wall anastomosis.
5. A chest drain was placed alongside the anastomosis. Receives: Procedure: Robotic repair for EA |
| Thoracoscopic repair group | Experimental | 1. All procedures were performed through three ports
2. Insufflation of the CO2 was at a flow rate of 1 L/min and a pressure of 4-6 mm Hg.
3. The azygos vein was ligated and cut, or divided by electrocoagulation.
4. The fistula was then dissociated, ligated with 4-0 absorbable sutures, and divided.
5. After identifying the proximal esophageal pouch with a nasogastatic tube, the proximal and distal blind ends were mobilized to prepare for anastomosis.
6. Next, the tip of the blind ends was excised, and the anastomosis was completed with 5-0 absorbable sutures in an interrupted manner.
7. A chest drain was placed alongside the anastomosis. Receives: Procedure: Thoracoscopic repair for EA |
| Thoracotomy repair | Active comparator | Usually, the fifth intercostal space was applied using the muscular-sparing technique. Fistula ligation, proximal pouch isolation and anastomosis were performed in turn.The fistula was then dissociated, ligated with 4-0 absorbable sutures, and divided. After identifying the proximal esophageal pouch with a nasogastatic tube, the proximal and distal blind ends were mobilized to prepare for anastomosis. Next, the tip of the blind ends was excised, and the anastomosis was completed with 5-0 absorbable sutures in an interrupted manner. A chest drain was placed alongside the anastomosis. Receives: Procedure: Thoracotomy repair for EA |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak
anastomotic leak within 30-days postoperative
Measured: 1 year
anastomotic stricture
stricture requiring dilation within 1 year
Measured: 1 year
Secondary outcomes (12)
vocal cord paresis/paralysis at discharge
Vocal cord paresis/paralysis was assessed in patients with symptoms such as aspiration or change in cry prompting a bronchoscopy for confirmation.
Measured: 1 year
time to anastomotic stricture
The time from surgery to the first occurrence of esophageal stenosis requiring dilation
Measured: 2 years
number of dilations in 1 year
The number of dilations of esophageal stenosis in 1 year
Measured: 1 year
esophageal dehiscence
The number of esophageal dehiscence happened in intraoperation.
Measured: 1 year
surgical site infection
Infection of surgical incision
Measured: 1 year
sepsis
Including severe pulmonary infections and sepsis caused by pleural effusion
Measured: 2 year
The use of vasopressors
Include the use of preoperative, intraoperative, postoperative vasopressors.
Measured: 1 year
Ventilation time
Include the usage time preoperative and postoperative ventilation.
Measured: 1 year
Time to full enteral feeds
Time to full enteral feeds
Measured: 1 year
Time to extubation
the time to extubation
Measured: 1 year
Postoperative length of stay
Postoperative length of stay
Measured: 1 year
mortality
Include the alive 30-days postoperation and died within 30-days
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Guiyang Children's Hospital, Guizhou Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Binzhou Medical University
- Responsible party
- Principal investigator, zebing Zheng, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208449
- Sponsor's protocol ID
- esophageal atresia
- Other IDs
- 82060100, ZK-2021-361
- Acronym
- RR VS TR VS OR
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Huang J, Jin Z, Zhang X, Zhou Y, Chi S, Rong L, Zhang Y, Cao G, Li S, Tang ST. Comparison of robotic versus thoracoscopic repair for congenital esophageal atresia: a propensity score matching analysis. Int J Surg. 2024 Feb 1;110(2):891-901. doi: 10.1097/JS9.0000000000000889.
PubMed 37983822Yang S, Wang P, Yang Z, Li S, Liao J, Hua K, Zhang Y, Zhao Y, Gu Y, Li S, Chen Y, Huang J. Clinical comparison between thoracoscopic and thoracotomy repair of Gross type C esophageal atresia. BMC Surg. 2021 Nov 22;21(1):403. doi: 10.1186/s12893-021-01360-7.
PubMed 34809633Marquart JP, Bowder AN, Bence CM, St Peter SD, Gadepalli SK, Sato TT, Szabo A, Minneci PC, Hirschl RB, Rymeski BA, Downard CD, Markel TA, Deans KJ, Fallat ME, Fraser JD, Grabowski JE, Helmrath MA, Kabre RD, Kohler JE, Landman MP, Lawrence AE, Leys CM, Mak GZ, Port E, Saito J, Silverberg J, Slidell MB, Wright TN, Lal DR; Midwest Pediatric Surgery Consortium. Thoracoscopy versus thoracotomy for esophageal atresia and tracheoesophageal fistula: Outcomes from the Midwest Pediatric Surgery Consortium. J Pediatr Surg. 2023 Jan;58(1):27-33. doi: 10.1016/j.jpedsurg.2022.09.015. Epub 2022 Sep 24.
PubMed 36283849
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia
- ClinicalTrials.gov ID
- NCT06208449
- Acronym / sponsor ID
- RR VS TR VS OR / esophageal atresia
- Conditions
- Congenital Esophageal Atresia
- Keywords
- robotic surgery, thoracoscopy repair, thoracotomy repair, esophageal atresia, efficacy, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Collaborators
- Guiyang Children's Hospital, Guizhou Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Binzhou Medical University
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2024 (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.
Thoracotomy repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient. thoracoscopy repair offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair. Robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair. However, there were no randomized controlled trials to verify the effectiveness of three procedures. The objection was to compare the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.
Detailed description
Esophageal atresia (EA) and tracheoesophageal fistula (TEF) is one of the most common congenital malformations of esophagus, with an incidence of 1/2500~1/4500. The condition can be an isolated malformation or may be associated with other congenital anomalies. Since Dr Cameron Height performed the first successful primary repair of a neonate with EA/ TEF in 1941, many advances in surgical technique and neonatal care have steadily improved survival rates of babies within the EA/TEF spectrum. Survival of infants with esophageal atresia has increased over time since the first successful repair and the overall survival exceeds 90%. Commonly, esophageal atresia is repaired via a right posterolateral thoracotomy and more recently muscle sparing thoracotomy has become an alternative to the traditional muscle cutting approach. Open repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient.
The first successful thoracoscopic surgery of a child with EA was reported in 1999. Compared to thoracotomy repair the proposed main advantage of thoracoscopic repair is that it offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair, thoracoscopic repair also offers concerns with more complicated anesthesia, limited workspace, and difficultly controlling the vascular structures. Especially, suturing within such a small, closed space has been considered a major technical difficulty.
Robotic repair was first reported by Meehan in 2009, followed by several case reports. The reported reasons for conversion mainly focused on the incompatibility between the robotic trocar\'s size and the intercostal space\'s width, and the technical challenges due to instrument collisions in the extremely limited thoracoscopic space. The intercostal space of neonates is highly narrow, and the thoracic diameter is only 8 cm. These are the two key technical issues to be addressed in this study. According to the existing robotic system setup standard for adults, the distance required between trocar ports in robots is usually at least 8 cm to ensure sufficient operating space and avoid instrument collisions. Even for the new generation of robots, this minimum distance requires 5-6 cm. Huge robotic trocars used in EA neonates fail to meet the standard for conventional operating port distances. There have study designed an asymmetric port distribution technique in which the third and eighth intercostal ports are 3 cm and 5 cm away from the camera port. The surgeons primarily manipulated the inner-articulating part of the robotic arms within the thoracic cavity, avoiding instrument collisions outside. Moreover, the setup of the trocars ensures that the robotic arms can reach the main operating area. When combined with instruments of 7 degrees of freedom, the mobilization and anastomosis of the esophagus could be completed easily, breaking through the narrow space restriction of thoracic cavity. Inserting 8-12 cm trocars into tiny intercostal space was another technical challenge. The results shown the robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair.
An international survey from 2014 highlighted the need for consensus on the optimal surgical treatment of EA. However, a detailed understanding of whether thoracoscopic repair or robotic repair offers advantages in terms of health outcomes, safety, and efficacy for providers compared to thoracotomy repair is still lacking. Several reviews are opinion-based or obscured by institutional/personal experiences. Herewith, we designed a comprehensive study and focused on evaluating the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic repair group | Experimental | Procedure: Robotic repair for EA1. the patients were lying in a left decubitus position (45° prone). 2. An 8-mm trocar was inserted into the thoracic cavity at the fifth intercostal space of the right midaxillary line and used as a camera port, Another two 8-mm trocars were placed at the third intercostal space of the right midaxillary line and the eighth intercostal space of the posterior axillary line. Insufflation of the CO2 was at a flow rate of 1 L/min and a pressure of 6 mm Hg. 3. The fistula was ligated and sutured by figure-of-eight suture ligation. The proximal blind end was fully mobilized and the distal blind end was properly mobilized to prepare for anastomosis. 4. Next, the 5-0 absorbable sutures were used to perform the anastomosis posteriorly and anteriorly in an interrupted way.. Thereafter, the nasogastric tube was inserted into the stomach. followed by another 6 sutures to complete the anterior wall anastomosis. 5. A chest drain was placed alongside the anastomosis. |
| Thoracoscopic repair group | Experimental | Procedure: Thoracoscopic repair for EA1. All procedures were performed through three ports 2. Insufflation of the CO2 was at a flow rate of 1 L/min and a pressure of 4-6 mm Hg. 3. The azygos vein was ligated and cut, or divided by electrocoagulation. 4. The fistula was then dissociated, ligated with 4-0 absorbable sutures, and divided. 5. After identifying the proximal esophageal pouch with a nasogastatic tube, the proximal and distal blind ends were mobilized to prepare for anastomosis. 6. Next, the tip of the blind ends was excised, and the anastomosis was completed with 5-0 absorbable sutures in an interrupted manner. 7. A chest drain was placed alongside the anastomosis. |
| Thoracotomy repair | Active comparator | Procedure: Thoracotomy repair for EAUsually, the fifth intercostal space was applied using the muscular-sparing technique. Fistula ligation, proximal pouch isolation and anastomosis were performed in turn.The fistula was then dissociated, ligated with 4-0 absorbable sutures, and divided. After identifying the proximal esophageal pouch with a nasogastatic tube, the proximal and distal blind ends were mobilized to prepare for anastomosis. Next, the tip of the blind ends was excised, and the anastomosis was completed with 5-0 absorbable sutures in an interrupted manner. A chest drain was placed alongside the anastomosis. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Type C EA neonates with short esophageal gap length (less than 3 vertebral bodies), mini-invasive repair, and a successful one-stage anastomosis were included.
Key exclusion criteria (2 listed)
- Patients with respiratory distress requiring assisted ventilation, long esophageal gap length, multistage surgery, other types EA (type A/B/D/E) or surgical contraindications were excluded.
- Gestational age less than 35 weeks and birth weight less than 2kg were excluded.
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 |
|---|---|---|
| Robotic repair for EAThe paitents with EA were repaired by Da Vinci robot | Procedure or surgery | Robotic repair group |
| Thoracoscopic repair for EAThe patients with EA were repaired by thoracoscopy | Procedure or surgery | Thoracoscopic repair group |
| Thoracotomy repair for EAThe patients with EA were repaired by traditional open thoracotomy. | Procedure or surgery | Thoracotomy repair |
Primary outcome
anastomotic leak
Time frame: 1 year
anastomotic leak within 30-days postoperative
anastomotic stricture
Time frame: 1 year
stricture requiring dilation within 1 year
12 secondary outcomes
vocal cord paresis/paralysis at discharge
Time frame: 1 year
time to anastomotic stricture
Time frame: 2 years
number of dilations in 1 year
Time frame: 1 year
esophageal dehiscence
Time frame: 1 year
surgical site infection
Time frame: 1 year
sepsis
Time frame: 2 year
The use of vasopressors
Time frame: 1 year
Ventilation time
Time frame: 1 year
Time to full enteral feeds
Time frame: 1 year
Time to extubation
Time frame: 1 year
Postoperative length of stay
Time frame: 1 year
mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 37983822Zhang M, Huang J, Jin Z, Zhang X, Zhou Y, Chi S, Rong L, Zhang Y, Cao G, Li S, Tang ST. Comparison of robotic versus thoracoscopic repair for congenital esophageal atresia: a propensity score matching analysis. Int J Surg. 2024 Feb 1;110(2):891-901. doi: 10.1097/JS9.0000000000000889.
- Background: PubMed 34809633Yang S, Wang P, Yang Z, Li S, Liao J, Hua K, Zhang Y, Zhao Y, Gu Y, Li S, Chen Y, Huang J. Clinical comparison between thoracoscopic and thoracotomy repair of Gross type C esophageal atresia. BMC Surg. 2021 Nov 22;21(1):403. doi: 10.1186/s12893-021-01360-7.
- Background: PubMed 36283849Marquart JP, Bowder AN, Bence CM, St Peter SD, Gadepalli SK, Sato TT, Szabo A, Minneci PC, Hirschl RB, Rymeski BA, Downard CD, Markel TA, Deans KJ, Fallat ME, Fraser JD, Grabowski JE, Helmrath MA, Kabre RD, Kohler JE, Landman MP, Lawrence AE, Leys CM, Mak GZ, Port E, Saito J, Silverberg J, Slidell MB, Wright TN, Lal DR; Midwest Pediatric Surgery Consortium. Thoracoscopy versus thoracotomy for esophageal atresia and tracheoesophageal fistula: Outcomes from the Midwest Pediatric Surgery Consortium. J Pediatr Surg. 2023 Jan;58(1):27-33. doi: 10.1016/j.jpedsurg.2022.09.015. Epub 2022 Sep 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic repair for EA, Thoracoscopic repair for EA and Thoracotomy repair for EA in people with Congenital Esophageal Atresia, run by Zunyi Medical College 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 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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?
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?
anastomotic leak (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208449, which also lists 3 linked publications.
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 17 Jan 2024.