Early feeding after surgery for oral cavity reconstruction
Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial
This study is testing if letting patients eat right after oral cavity surgery is safe and helps them recover better compared to waiting to eat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 89 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04787939 on ClinicalTrials.gov |
What this trial studies
This prospective single-arm non-inferiority trial evaluates the safety and outcomes of allowing patients to eat immediately after oral cavity reconstructive surgery. The study compares the rates of orocutaneous fistula in patients who begin oral feeding on postoperative day 1 to those reported in existing literature where feeding is delayed. Eighty-nine subjects will be enrolled at Mount Sinai Hospital and Mount Sinai West, with follow-up assessments for surgical site infections, swallow function, and patient-reported outcomes over a 30-day period post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older undergoing free tissue transfer for oral cavity reconstruction who can provide informed consent.
Not a fit: Patients with prior major oral cavity surgery, dysphagia, or those requiring enteral feeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and better quality of life for patients undergoing oral cavity reconstruction.
How similar studies have performed: Previous studies on early oral feeding after total laryngectomy have shown no increased risk, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York
- Mount Sinai Health System — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mohemmed Khan, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Rocco Ferrandino, MD
- Email: Rocco.ferrandino@mountsinai.org
- Phone: (212) 844-8775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.