Clinical trial NCT05542680: Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
Official title: Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reflux symptoms
timeFrame: 1 to 30 days after surgery
Secondary outcomes:
measure: Postoperative quality of life QLQ-C30
timeFrame: 7 days after surgery
measure: Postoperative quality of life QLQ-OES18
timeFrame: 7 days after surgery
measure: Skin pressure injury
timeFrame: 7 to 180 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
References: