Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787939
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2021-03-04
Brief Title:
Early Feeding After Oral Cavity Reconstruction
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Early Feeding After Free Flap Reconstruction of Oral Cavity Defects A Single Arm Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cohorts 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
In addition to salivary leak rates the study team will report outcomes related to the cohorts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None