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

NCT ID: NCT04251312

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2021-12-29

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.

Detailed Description

Aspiration by high risk esophageal and lung cancer patients with either preexisting or post-therapy/post-operative dysphagia leads to morbidity (pneumonia) and mortality following surgery. 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

Study Design

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

Study Groups

Preoperative dental hygiene education

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.

Group Type: EXPERIMENTAL

Oral Hygiene Education and Oral Hygiene Packets

Intervention Type: OTHER

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

Interventions

Oral Hygiene Education and Oral Hygiene Packets

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

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

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jacob Moremen

Assistant Professor of Cardio-Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob Moremen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 30291834 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28816937 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16790829 (View on PubMed)

Other Identifiers

2019-0327

Identifier Type: -

Identifier Source: org_study_id