Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52912
Enrollment
19
Registered
2019-11-11
Start date
2020-11-26
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

esophageal cancer

Interventions

Introduction of an additional nasogastric tube at the site of the anastomosis. In 3 patients assessment of the pressure in the esophagus. In the next 10 patients oxygen delivery through the nasogastri

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients with esophageal cancer scheduled for a minimal invasive esophageal resection with an intrathoracic anastomosis - 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

MeasureTime frame
- To assess the successful placement of the intervention nasogastric oxygen delivery tube. - To assess the tolerance and feasibility of the intervention nasogastric oxygen delivery tube for oxygen administration during the first 5 days after surgery. - To assess the amount of discomfort patients have of the extra nasogastric tube. - To monitor the intraluminal pressure via the oxygen delivery tube and keep it under 20 mmHg

Secondary

MeasureTime 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). - To what extent does the administration of intraluminal oxygen at the site of the anastomosis effect theanastomotic leak rate in patients who underwent an esophagectomy?(normal rate 20%)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)