Status:
RECRUITING
Early Feeding After Oral Cavity Reconstruction
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Head and Neck Cancer
Free Tissue Transfer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to s...
Detailed Description
In this single-arm non-inferiority study, the study team will aim to evaluate the safety of early feeding in patients with oral cavity reconstruction who are allowed to eat by mouth on post-operative ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients receiving free tissue transfer regardless of the indication for oral cavity reconstruction will be included.
- Age ≥ 18 years.
- English, Spanish, and Chinese (Mandarin) speaking patients
- Ability to understand and the willingness to sign a written informed consent.
- Exclusion Criteria
- Patients having undergone prior major oral cavity surgery or radiation to the oral cavity (also known as surgical salvage patients).
- Patients with a known history of dysphagia or with current enteral feeding needs
- Patients with a history of traumatic brain injury, stroke, or dementia
- Patients unable to understand the research protocol and/or provide informed consent. The consent will be translated into English, Spanish, and Chinese (Mandarin). Given patient demographics at Mount Sinai Hospital, this will include the overwhelming majority of patients.
- Patients under the age of 18
- Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.
- Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, pregnant women, prisoners, pregnant women)
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04787939
Start Date
March 10 2021
End Date
December 1 2025
Last Update
April 12 2024
Active Locations (1)
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1
Mount Sinai Health System
New York, New York, United States, 10029