Early Feeding After Oral Cavity Reconstruction

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Mar 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how soon patients can start eating after having surgery to reconstruct the mouth due to head and neck cancer. The researchers want to find out if allowing patients to eat right after surgery leads to fewer complications, specifically a type of problem called orocutaneous fistula, compared to what has been reported in other studies where patients had to wait several days before eating. The trial will include 89 patients at Mount Sinai Hospital and Mount Sinai West, and those who participate will be monitored for 30 days after their surgery for any signs of infection, issues with healing, and how well they can swallow.

To be eligible for this study, participants need to be at least 18 years old and must be able to speak English, Spanish, or Mandarin. They should also be undergoing a specific type of surgery called free tissue transfer. However, people who have had major oral surgery before, have difficulty swallowing, or have certain medical conditions will not be included. If you decide to join the trial, you will attend follow-up appointments where the medical team will check on your recovery and ask about your experiences after surgery.

Gender

ALL

Eligibility 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)