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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05542680
Other study ID # NCC2021C-266
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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