Evaluating the feasibility of intraluminal oxygen administration at the site of the anastomosis in patients who underwent an esophagectomy; a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27654

Enrollment

Registered

2019-09-13

Start date

2020-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal carcinoma Minimally invasive esophagectomy Intrathoracic anastomosis

Interventions

Introduction of an additional nasogastric tube at the site of the anastomosis and delivery of oxygen flow

Eligibility

Inclusion criteria

Inclusion criteria: - Patients scheduled for a minimally invasive esophagectomy for esophageal cancer with an intrathoracic gastric conduit reconstruction in the UMC Groningen. - Aged 18 years or older. - Signed informed consent.

Exclusion criteria

Exclusion criteria: - Known nasopharynx abnormalities preventing nasogastric tube insertion - Salvage surgery after ‘definitive chemo-radiotherapy’ - Unable to provide informed consent - Patient being illiterate

Design outcomes

Primary

Measure	Time frame
-To assess the successful placement of the oxygen delivery tube. -To assess the tolerance and feasibility of the oxygen delivery tube for oxygen administration during the first 5 days after surgery. -To assess patients discomfort of the extra nasogastric tube.	—

Secondary

Measure	Time frame
- To explore the safety of the administration of intraluminal oxygen via an extra nasogastric tube at the site of the anastomosis in patients who underwent an esophagectomy (bleeding, gastric tube distention). - Anastomotic leak rate (normal 20%)	—

Contacts

Public ContactJan Willem Haveman

UMCG

j.w.haveman@umcg.nl0652724042

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)