Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05542680
• Other study ID #: NCC2021C-266
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: August 2022
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".

2. to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.

Description:

1. Make application-oriented achievement transformation products to provide new special semi recumbent auxiliary tools for patients with esophageal cancer after operation. Summarize the clinical experience and evidence, sign the project cooperation intention agreement with the manufacturer with production qualification, connect with the professional designer of the manufacturer and refine and improve the design scheme; The angle range, materials, fabrics and connection methods of the semi reclining cushion are closely combined with the clinical treatment and patient needs to meet the effectiveness, comfort and practicality of the patient's application; To produce semi reclining cushion products to provide semi reclining cushion for patients after esophageal cancer surgery that can be adjusted from multiple angles and take into account the skin protection function, which is conducive to preventing and alleviating reflux symptoms, improving the quality of life and reducing the risk of skin stress injury.

2. Implement and evaluate the effectiveness of the special semi reclining cushion after esophageal cancer surgery, apply the product to patients after esophageal cancer surgery, and evaluate the effect.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: October 31, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

1. transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".

2. to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer. 1. patients with pathologically confirmed esophageal cancer who underwent thoracoscopic resection and neck anastomosis;

2. age = 18 years old; 3. able to read and fill in the questionnaire independently.

Exclusion criteria:

1. cognitive impairment or mental illness;

2. complicated with other serious diseases;

3. unwilling to participate in this study.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Device:
• cushion
In the intervention group, the special cushion for semi recumbent position was used

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflux symptoms	Reflux Diagnostic Questionnaire RDQ	1 to 30 days after surgery
Secondary	Postoperative quality of life QLQ-C30	European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30	7 days after surgery
Secondary	Postoperative quality of life QLQ-OES18	European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18	7 days after surgery
Secondary	Skin pressure injury	The staging standard of pressure injury published by the national pressure sore Advisory Committee of the United States was applied to skin pressure injury	7 to 180 days after surgery