RECRUITINGINTERVENTIONAL

Early Feeding After Oral Cavity Reconstruction

Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form. 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 willing to sign a consent form. 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

BEHAVIORAL

Early Feeding

Subjects will be permitted to drink liquids by mouth on the first day after surgery. Outcomes related to their care, wound healing, and quality of life will be followed for 30 days after surgery.

Locations (1)

Mount Sinai Health System

New York, New York, United States