Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the thoracic cavity and may therefore cause hypercapnia and acidosis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypercapnia during thoracoscopy | Experimental | keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates |
|
| Open surgery | Experimental | open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypercapnia during thoracoscopy | Procedure | keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood carbon dioxide measurement | Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| oxygenation of the brain | oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy | Intra-operative and 24 hours post-operatively |
Not provided
Inclusion Criteria:
Neonates with diagnosis of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia
->1.6 Kg
Conventional ventilation (no high frequency ventilation or iNO) for at least 24 hours.
FiO2 <0.4
No requirement for inotropes for at least 24 hours
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Agostino Pierro, Prof | Great Ormond Street Hospital for Children NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital for Children NHS Trust | London | WC1N 3JH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16150335 | Background | Yang EY, Allmendinger N, Johnson SM, Chen C, Wilson JM, Fishman SJ. Neonatal thoracoscopic repair of congenital diaphragmatic hernia: selection criteria for successful outcome. J Pediatr Surg. 2005 Sep;40(9):1369-75. doi: 10.1016/j.jpedsurg.2005.05.036. | |
| 16135928 | Background | Holcomb GW 3rd, Rothenberg SS, Bax KM, Martinez-Ferro M, Albanese CT, Ostlie DJ, van Der Zee DC, Yeung CK. Thoracoscopic repair of esophageal atresia and tracheoesophageal fistula: a multi-institutional analysis. Ann Surg. 2005 Sep;242(3):422-8; discussion 428-30. doi: 10.1097/01.sla.0000179649.15576.db. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Open surgery | Procedure | open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates |
|
| 15960636 | Background | Krosnar S, Baxter A. Thoracoscopic repair of esophageal atresia with tracheoesophageal fistula: anesthetic and intensive care management of a series of eight neonates. Paediatr Anaesth. 2005 Jul;15(7):541-6. doi: 10.1111/j.1460-9592.2005.01594.x. |
| 23604057 | Result | Bishay M, Giacomello L, Retrosi G, Thyoka M, Garriboli M, Brierley J, Harding L, Scuplak S, Cross KM, Curry JI, Kiely EM, De Coppi P, Eaton S, Pierro A. Hypercapnia and acidosis during open and thoracoscopic repair of congenital diaphragmatic hernia and esophageal atresia: results of a pilot randomized controlled trial. Ann Surg. 2013 Dec;258(6):895-900. doi: 10.1097/SLA.0b013e31828fab55. |
| ID | Term |
|---|---|
| C531835 | Esophageal atresia with or without tracheoesophageal fistula |
| D065630 | Hernias, Diaphragmatic, Congenital |
| D004933 | Esophageal Atresia |
| D006935 | Hypercapnia |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided