Early Feeding After Oral Cavity Reconstruction

NCT ID: NCT04787939

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Head and Neck Cancer; Free Tissue Transfer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early Feeding Arm

Early Feeding Group

Group Type: EXPERIMENTAL

Early Feeding

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Mohemmed Khan

Assistant Professor, Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohemmed Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Health System

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rocco Ferrandino, MD

Role: CONTACT

Rocco.ferrandino@mountsinai.org

(212) 844-8775

Catharine Kappauf, MD

Role: CONTACT

catharine.kappauf@mountsinai.org

Facility Contacts

Mohemmed Khan, MD

Role: primary

mohemmed.khan@mountsinai.org

212-844-8775

Other Identifiers

HSM 20-01801

Identifier Type: -

Identifier Source: org_study_id