RecruitingNot ApplicableNCT04787939

Early Feeding After Oral Cavity Reconstruction

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

89 participants

Start Date

Mar 10, 2021

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Free Tissue Transfer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best time to start feeding patients by mouth after surgery that reconstructs the inside of the mouth using tissue from another part of the body (called free tissue transfer or flap surgery). Researchers want to find out whether feeding patients earlier after surgery is safe and leads to better recovery. **You may be eligible if...** - You are 18 or older - You are having mouth reconstruction surgery using tissue from another part of your body (free tissue transfer flap) - You speak English, Spanish, or Mandarin - You are willing and able to give written consent **You may NOT be eligible if...** - You have had previous major mouth surgery or radiation to the mouth area - You have a known history of swallowing difficulties (dysphagia) before surgery Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEarly 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.