It is feasible to introduce the nasogastric tube for oxygen administration during the first 5 days after surgery
Bron
Verkorte titel
Aandoening
Esophageal carcinoma
Minimally invasive esophagectomy
Intrathoracic anastomosis
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
- 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.
Achtergrond van het onderzoek
Rationale: Anastomotic leakage is a severe complication after esophagectomy and causes high morbidity and mortality. Unfortunately, anastomotic leakage still occurs in 20% of patients after an esophagectomy. The leakage of the anastomosis is frequently caused by local ischemia of the gastric conduit postoperative. Various methods have been tested in order to decrease the occurrence of anastomotic leakage. None of these methods has been successful in reducing the occurrence in a major manner. There is however a potential novel solution to this problem, which is the intraluminal administration of oxygen at the site of the anastomosis. This intraluminal oxygen diffuses into mucosa to prevent ischemia, and also stimulates tissue regeneration. This study is the first step to come to a safe intraluminal oxygen delivery device intended to reduce anastomotic leakage.
Objective: To explore the feasibility of intraluminal oxygen administration at the site of the anastomosis in patients who underwent an esophagectomy using a nasogastric tube for the first 5 days after surgery.
Study design: Pilot feasibility study.
Study population: 13 patients ≥ 18 years old scheduled for a minimal invasive esophagectomy with an intrathoracic anastomosis in the UMCG.
Intervention: Introduction of an additional nasogastric tube at the site of the anastomosis and delivery of oxygen flow.
Main study parameters/endpoints: successful placement of the interventional nasogastric tube during surgery. Tolerance and discomfort of the patient for the additional nasogastric tube used for the oxygen administration, during the first 5 days after surgery.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The subjects can have benefit participating in this study by having a reduced chance of an anastomotic leakage. There are potential risks present, but it is expected that these risks are surmountable or reversible, mainly because the volume of oxygen delivery is very small. Furthermore, this study is intended as stepping stone to develop safe intraluminal oxygen delivery device intended to reduce anastomotic leakage, not limited to leakages after esophagectomies.
Doel van het onderzoek
It is feasible to introduce the nasogastric tube for oxygen administration during the first 5 days after surgery
Onderzoeksopzet
Follow-up: 3 months
Onderzoeksproduct en/of interventie
Introduction of an additional nasogastric tube at the site of the anastomosis and delivery of oxygen flow
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Known nasopharynx abnormalities preventing nasogastric tube insertion
- Salvage surgery after ‘definitive chemo-radiotherapy’
- Unable to provide informed consent
- Patient being illiterate
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8026 |
Ander register | METc UMCG : 2019/385 |