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Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia (RR VS TR VS OR)

Z

Zunyi Medical College

Status

Active, not recruiting

Conditions

Congenital Esophageal Atresia

Treatments

Procedure: Thoracoscopic repair for EA
Procedure: Thoracotomy repair for EA
Procedure: Robotic repair for EA

Study type

Interventional

Funder types

Other

Identifiers

NCT06208449
esophageal atresia
82060100 (Other Grant/Funding Number)
ZK-2021-361 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 3 patient groups

Robotic repair group
Experimental group
Description:
the patients were lying in a left decubitus position (45° prone). 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. 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. 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. A chest drain was placed alongside the anastomosis.
Treatment:
Procedure: Robotic repair for EA
Thoracoscopic repair group
Experimental group
Description:
All procedures were performed through three ports Insufflation of the CO2 was at a flow rate of 1 L/min and a pressure of 4-6 mm Hg. The azygos vein was ligated and cut, or divided by electrocoagulation. 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.
Treatment:
Procedure: Thoracoscopic repair for EA
Thoracotomy repair
Active Comparator group
Description:
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.
Treatment:
Procedure: Thoracotomy repair for EA

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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