Clinical trial NCT04787939: Early Feeding After Oral Cavity Reconstruction
Official title: Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Free Tissue Transfer
Keywords: Oral Cavity Cancer
Oral Cavity Reconstruction
Early Postoperative Feeding
Orocutaneous Fistula
Salivary Leak
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a single arm non-inferiority study evaluating wound healing outcomes (orocutaneous fistula, salivary leak, wound dehiscence) in subjects undergoing free tissue transfer for oral cavity reconstruction who are permitted to drink liquids by mouth on postoperative day 1. Outcomes are tracked and assessed over a 30 day period postoperatively.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Incidence of Orocutaneous Fistula
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of Surgical Site Infection
timeFrame: 30 days
measure: Incidence of Wound Dehiscence
timeFrame: 30 days
measure: Rate of PO tolerance
timeFrame: 30 days
measure: Incidence of Aspiration pneumonia
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Jaw range of motion
timeFrame: 30 days
measure: Tongue range of motion
timeFrame: 30 days
measure: MD Anderson Dysphagia Index (MDADI)
timeFrame: 30 Days
measure: Performance Status Scale for Head and Neck Cancer (PSS-HN)
timeFrame: 30 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mohemmed Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: