- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542680
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
September 13, 2022 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.
Study Overview
Detailed Description
- 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.
- 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.
Study Type
Interventional
Enrollment (Anticipated)
134
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- 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:
- cognitive impairment or mental illness;
- complicated with other serious diseases;
- unwilling to participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
In the intervention group, the special cushion for semi recumbent position was used
|
In the intervention group, the special cushion for semi recumbent position was used
|
No Intervention: Group 2
Routine nursing intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reflux symptoms
Time Frame: 1 to 30 days after surgery
|
Reflux Diagnostic Questionnaire RDQ
|
1 to 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative quality of life QLQ-C30
Time Frame: 7 days after surgery
|
European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30
|
7 days after surgery
|
Postoperative quality of life QLQ-OES18
Time Frame: 7 days after surgery
|
European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18
|
7 days after surgery
|
Skin pressure injury
Time Frame: 7 to 180 days after surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 30, 2022
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
October 31, 2023
Study Registration Dates
First Submitted
August 28, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 15, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC2021C-266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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