None listed
Conditions
Brief summary
This study will allow to evaluate prospectivelly the possibility of outpatient PEG placement procedure in a cohort of patients with head and neck tumors with good status and low or moderate surgical anesthetic risk. PEG placement on outpatient basis will be helpful for patients, caregivers and the hospital.
Interventions
PEG placement is performed by two gastroenterologists under deep sedation performed by an anesthesiologist. The procedure takes about 15 minutes and it provides the patient a feeding tube conecting the gastric cavity to the outside for enteral nutrition. The ambulatory participant will be discharged without need for hospitalization 4 hours after the procedure. Oral analgesia for ambulatory (acetaminophen 1g every 8 hous, as needed) will be provided with a prescription provided by the gastroe
PEG placement is performed by two gastroenterologists under deep sedation performed by an anesthesiologist. The procedure takes about 15 minutes and it provides the patient a feeding tube conecting the gastric cavity to the outside for enteral nutrition. The ambulatory participant will be discharged without need for hospitalization 4 hours after the procedure. Oral analgesia for ambulatory (acetaminophen 1g every 8 hous, as needed) will be provided with a prescription provided by the gastroenterologist after patient evaluation, prior to discharge. The patient or a care-guiver will be responsible for oral analgesia administration.
Sponsors
Sandra Faias
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with head and neck tumors referenced for PEG placement ASA Class <IV Performance Scale ECOG Status <3 Have quick access to the IPO Urgency (<1h by car) within 24 hours after the procedure. Have a caregiver within the first 24 hours after the procedure at your residence. Age> 18 years and <80 years Ability to provide informed consent
Exclusion criteria
Refusal of the patient Inability to provide informed consent Need for dilation prior to PEG placement Impossibility to access the IPO Urgency in the first 24 hours after the procedure in a period less than 1h Contraindications for PEG placement (patients unable to take PEG, chronic liver disease, presence of ascites, thrombocytopenia (<50,000 platelets), coagulopathy (INR> 1.5). Associated pathology: acute myocardial infarction and / or stroke for less than 1 year; severe tachyarrhythmia under treatment for less than 6 months; cardiac stent (s) placed for less than one year with a need for discontinuation of antiplatelet agents; severe renal insufficiency (creatinine greater than or equal to 2); severe respiratory insufficiency with SaO2 less than or equal to 90% without oxygen supply.
Outcome results
None listed