Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia

NCT06208449 | Unknown DMC

• 3 other identifiers: esophageal atresia82060100ZK-2021-361
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Congenital Esophageal Atresia

Keywords

robotic surgery; thoracoscopy repair; thoracotomy repair; esophageal atresia; efficacy; complications

Outcome Measures

Primary Outcomes (2)

• anastomotic leak

  anastomotic leak within 30-days postoperative

  1 year

• anastomotic stricture

  stricture requiring dilation within 1 year

  1 year

Secondary Outcomes (12)

• vocal cord paresis/paralysis at discharge

  1 year

• time to anastomotic stricture

  2 years

• number of dilations in 1 year

  1 year

• esophageal dehiscence

  1 year

• surgical site infection

  1 year

Study Arms (3)

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.

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.

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.

Procedure: Thoracotomy repair for EA

Interventions

Robotic repair for EA PROCEDURE

The paitents with EA were repaired by Da Vinci robot

Robotic repair group

Thoracoscopic repair for EA PROCEDURE

The patients with EA were repaired by thoracoscopy

Thoracoscopic repair group

Thoracotomy repair for EA PROCEDURE

The patients with EA were repaired by traditional open thoracotomy.

Thoracotomy repair

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zunyi Medical College: lead
• Guiyang Children's Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Binzhou Medical University: collaborator

Study Sites (1)

Affiliated hospital of zunyi medical university

Zunyi, Guizhou, 56300, China

Location

Related Publications (3)

• 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.

  PMID: 37983822 BACKGROUND

• 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.

  PMID: 34809633 BACKGROUND

• 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.

  PMID: 36283849 BACKGROUND

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 17, 2024
• Study Start: January 15, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)