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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Congenital Esophageal Atresia
• Intervention / Treatment: Procedure: Robotic repair for EA; Procedure: Thoracoscopic repair for EA; Procedure: Thoracotomy repair for EA

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Zunyi, Guizhou, China, 56300
      • Affiliated Hospital of Zunyi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic repair group; 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.	Procedure: Robotic repair for EA; The paitents with EA were repaired by Da Vinci robot
Experimental: Thoracoscopic repair group; 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.	Procedure: Thoracoscopic repair for EA; The patients with EA were repaired by thoracoscopy
Active Comparator: Thoracotomy repair; 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.	Procedure: Thoracotomy repair for EA; The patients with EA were repaired by traditional open thoracotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic leak	anastomotic leak within 30-days postoperative	1 year
anastomotic stricture	stricture requiring dilation within 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
time to anastomotic stricture	The time from surgery to the first occurrence of esophageal stenosis requiring dilation	2 years
number of dilations in 1 year	The number of dilations of esophageal stenosis in 1 year	1 year
esophageal dehiscence	The number of esophageal dehiscence happened in intraoperation.	1 year
surgical site infection	Infection of surgical incision	1 year
sepsis	Including severe pulmonary infections and sepsis caused by pleural effusion	2 year
The use of vasopressors	Include the use of preoperative, intraoperative, postoperative vasopressors.	1 year
Ventilation time	Include the usage time preoperative and postoperative ventilation.	1 year
Time to full enteral feeds	Time to full enteral feeds	1 year
Time to extubation	the time to extubation	1 year
Postoperative length of stay	Postoperative length of stay	1 year
mortality	Include the alive 30-days postoperation and died within 30-days	1 year

Collaborators and Investigators

• Sponsor: Zunyi Medical College
• Collaborators: Guizhou Provincial People's Hospital; Binzhou Medical University; Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology; Guiyang Children's Hospital

Publications and helpful links

General Publications

• Zhang M, Huang J, Zhong W, 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. 2023 Nov 17. doi: 10.1097/JS9.0000000000000889. Online ahead of print.
• Yang 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.
• Marquart 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: complications; efficacy; robotic surgery; esophageal atresia; thoracoscopy repair; thoracotomy repair
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Esophageal Diseases; Digestive System Abnormalities; Esophageal Atresia
• Other Study ID Numbers: esophageal atresia; 82060100 (Other Grant/Funding Number: National Natural Science Foundation of China); ZK-2021-361 (Other Grant/Funding Number: Basic Research Project of Guizhou Province China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No