Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT04787939

Conditions

Head and Neck Cancer

Free Tissue Transfer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early Feeding

Study Details

Brief 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

Head and Neck Cancer

Free Tissue Transfer

Study ID

NCT04787939

Start date

Mar 10, 2021

Status verified date

Apr, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

89 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Early Feeding Arm

Early Feeding Group

Interventions

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.

Primary outcome measure

  • Incidence of Orocutaneous Fistula [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Rocco Ferrandino, MD

(212) 844-8775Rocco.ferrandino@mountsinai.org

Catharine Kappauf, MD

catharine.kappauf@mountsinai.org

Locations

Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

Contacts

Mohemmed Khan, MD

212-844-8775mohemmed.khan@mountsinai.org

Principal Investigator:

Mohemmed Khan, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Keywords

  • Oral Cavity Cancer
  • Oral Cavity Reconstruction
  • Early Postoperative Feeding
  • Orocutaneous Fistula
  • Salivary Leak

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2024-04-12.