Early Feeding After Oral Cavity Reconstruction

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Free Tissue Transfer
• Intervention / Treatment: Behavioral: Early Feeding

Detailed Description

In this single-arm non-inferiority study, the study team will aim to evaluate the safety of early feeding in patients with oral cavity reconstruction who are allowed to eat by mouth on post-operative day 1. Traditionally, surgeons have opted to delay the time to oral feeding in oral cavity reconstruction because of concern that an early oral diet may stress intraoral suture lines and lead to the development of salivary leaks. However, evidence from small studies evaluating oral feeding timing in patients who underwent total laryngectomy suggests that there is no increased risk associated with early oral feeding. As such, the study team will aim to determine whether early feeding on postoperative day 1 is non-inferior with respect to the development of orocutaneous fistula to the standard care as described in the literature. There are roughly 50-60 oral cavity reconstructive surgeries performed at Mount Sinai each year - as such it is not feasible to recruit two study arms for direct comparison.

In addition to salivary leak rates, the study team will report outcomes related to the cohort's wound healing, length of time in the hospital, length of time requiring an enteral tube feeds, swallow evaluation information, and the results of patient reported outcomes measures.

• Study Type: Interventional
• Enrollment (Estimated): 89
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocco Ferrandino, MD; Phone Number: (212) 844-8775; Email: Rocco.ferrandino@mountsinai.org
• Study Contact Backup: Name: Catharine Kappauf, MD; Email: catharine.kappauf@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Health System
      • Contact: Mohemmed Khan, MD; Phone Number: 212-844-8775; Email: mohemmed.khan@mountsinai.org
      • Principal Investigator: Mohemmed Khan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Feeding Arm; Early Feeding Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Orocutaneous Fistula	Orocutaneous Salivary Fistula Formation - An orocutaneous fistula or salivary leak is a wound complication that results when saliva or other liquids leak from the mouth through the skin of the face or neck. The subject's oral cavity and neck will be monitored in the standard fashion for development of orocutaneous fistula. The oral cavity will be monitored daily for signs of wound breakdown. The neck will be examined for redness, tenderness to palpation, or increased swelling. Additionally, systemic signs of fistula formation will be monitored such as leukocytosis and fever.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection	Surgical site infection is defined clinically as fever, erythema, swelling or purulent drainage from the surgical site requiring topical or systemic treatment.	30 days
Incidence of Wound Dehiscence	Wound dehiscence is defined as the breakdown at the surgical site with or without intervention.	30 days
Rate of PO tolerance	The proportion of patients that are cleared for a diet by the speech language pathology team.	30 days
Incidence of Aspiration pneumonia	Aspiration pneumonia is defined clinically based on vital signs, respiratory secretions, and chest x-ray findings indicating pneumonia requiring antibiotic treatment.	30 days
Length of hospital stay	Length of hospital stay is defined as the days from admission to discharge.	30 days
Jaw range of motion	Bedside swallow evaluation outcomes include jaw Jaw Range of Motion opening which will be measured in millimeters using the Therabite measuring tool and fingers, ranges from 0, indicating <1, to 5, indicating 3 or greater.	30 days
Tongue range of motion	Bedside swallow evaluation outcomes include tongue range of motion. Tongue Range of Motion Scale will be measured in millimeters, with a range of 100-0, 100 indicating full tongue range of motion and 0 indication no tongue movement.	30 days
MD Anderson Dysphagia Index (MDADI)	MD Anderson Dysphagia Index (MDADI) is a survey designed to assess a subject's perception of his or her swallowing ability. Patient responds to questionnaire that best reflects their current experience, ranges from Strongly Agree to Strongly Disagree. The scores range from a minimum of 0 to a max of 100, with higher scores indicating higher functioning.	30 Days
Performance Status Scale for Head and Neck Cancer (PSS-HN)	Performance Status Scale for Head and Neck Cancer (PSS-HN) is a survey aimed at evaluating performance and function with regard to eating, speaking, and eating in public. Subscales provide a range of 100 - No restrictions and full understandability to 0 - Full restrictions and no understandability. Subscales are scored individually with higher scores indicating better performance.	30 Days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mohemmed Khan, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Oral Cavity Cancer; Oral Cavity Reconstruction; Early Postoperative Feeding; Orocutaneous Fistula; Salivary Leak
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HSM 20-01801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No