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Early Feeding After Oral Cavity Reconstruction
NCT04787939 · View on ClinicalTrials.gov ↗
Study 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 specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately after surgery to those rates published in the literature (individuals for whom oral feeding is delayed for several days after surgery). Eighty nine subjects who will undergo oral cavity reconstructive surgery will be enrolled between Mount Sinai Hospital and Mount Sinai West. Study participation will last for 30 days after surgery during which time patients will be examined for any signs or symptoms of surgical site infection or wound breakdown, have several clinical evaluations of swallow function, and be asked to report on several patient reported outcome measures.
Conditions Studied
Interventions
- BEHAVIORAL Early Feeding
Study Locations (1)
New York
- Mount Sinai Health System — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04787939
The ClinicalTrials.gov registry entry for NCT04787939 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention — of which Early Feeding is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04787939 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04787939 about?
NCT04787939 is a clinical study titled "Early Feeding After Oral Cavity Reconstruction". 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 specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately...
What is the current status of trial NCT04787939?
This trial is currently recruiting. It is a NA study. The enrollment target is 89 participants. The study started on 2021-03-10. Estimated completion is 2025-12.
What conditions does trial NCT04787939 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Free Tissue Transfer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04787939?
The interventions under investigation include: Early Feeding (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04787939?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04787939 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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