Minimizing Pathologic Aspiration in Patients Undergoing Esophageal and Lung Resections for Cancer

NCT04251312 | Completed

• 1 other identifier: 2019-0327
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to reduce pathologic aspiration and pneumonia in the perioperative period by providing an oral care and oral hygiene education to patients preoperatively. Patients enrolled in the study will be given a dysphagia screening questionnaire, an oral care package and oral hygiene education. Patients who screen positive for dysphagia will be referred to Speech Pathology for evaluation. The rate of postoperative pneumonia will be determined for those who participate in the study and will be compared to retrospective patient data from our institution.

Conditions

Esophageal Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of pneumonia

  Number of participants who develop postoperative pneumonia in the interventional arm compared to the number of patients retrospectively reviewed who received no intervention

  6 months

Study Arms (1)

Preoperative dental hygiene education

EXPERIMENTAL

Patients who are scheduled for elective esophageal or lung resections who consent to participate will undergo oral hygiene education and be given an oral hygiene packet. An oral hygiene assessment using the Plaque Assessment tool will be conducted in the clinic. A Dysphagia Screening Tool questionnaire will also be administered. Patients who screen positive for dysphagia will be referred to Speech Pathology for evaluation but for the study purposes, the only data collected from the evaluation will be whether or not the participant received this intervention. A repeat dental exam will occur on the day of surgery. Patients will be followed for 30 days post operatively.

Other: Oral Hygiene Education and Oral Hygiene Packets

Interventions

Oral Hygiene Education and Oral Hygiene Packets OTHER

Patients will be educated on oral hygiene and will be given packets containing toothpaste, mouth rinse, floss and a toothbrush

Preoperative dental hygiene education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective esophageal or lung resections for cancer at our institution

You may not qualify if:

• None

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (3)

• Semenkovich TR, Frederiksen C, Hudson JL, Subramanian M, Kollef MH, Patterson GA, Kreisel D, Meyers BF, Kozower BD, Puri V. Postoperative Pneumonia Prevention in Pulmonary Resections: A Feasibility Pilot Study. Ann Thorac Surg. 2019 Jan;107(1):262-270. doi: 10.1016/j.athoracsur.2018.08.008. Epub 2018 Oct 3.

  PMID: 30291834 RESULT

• Soutome S, Yanamoto S, Funahara M, Hasegawa T, Komori T, Yamada SI, Kurita H, Yamauchi C, Shibuya Y, Kojima Y, Nakahara H, Oho T, Umeda M. Effect of perioperative oral care on prevention of postoperative pneumonia associated with esophageal cancer surgery: A multicenter case-control study with propensity score matching analysis. Medicine (Baltimore). 2017 Aug;96(33):e7436. doi: 10.1097/MD.0000000000007436.

  PMID: 28816937 RESULT

• Hernan MA, Robins JM. Estimating causal effects from epidemiological data. J Epidemiol Community Health. 2006 Jul;60(7):578-86. doi: 10.1136/jech.2004.029496.

  PMID: 16790829 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jacob Moremen, M.D.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardio-Thoracic Surgery

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 31, 2020
• Study Start: January 14, 2020
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)