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NCT Number: NCT05542680

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

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

cushion

Device

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

Primary outcomes

  1. Reflux symptoms

    Time frame: 1 to 30 days after surgery

    Reflux Diagnostic Questionnaire RDQ The Reflux Diagnostic Questionnaire includes four symptoms: heartburn, acid reflux, regurgitation, and pain behind the sternum. The frequency and severity of symptoms range from 0 to 5 points. The highest score for symptom frequency and severity is 40 points. A higher score indicates more severe reflux, and a score exceeding 12 points indicates a preliminary diagnosis of gastroesophageal reflux disease

Secondary outcomes

  1. 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

    The Quality of Life Questionnaire QLQ-C30 is a tool for assessing the quality of life of cancer patients, with 30 items divided into 15 domains. The scoring method is as follows:

    For items 29 and 30, score from 1 to 7 according to the answer options; for other items, score from 1 to 4 according to the answer options .

    Add up the scores of the items included in each domain and divide by the number of items included, to get the raw score of that domain .

    Use the range method to perform a linear transformation, converting the raw score into a standardized score between 0 and 100 .

    For functional domains and overall health status/quality of life domain, the higher the score, the better the functional status and quality of life; for symptom domains, the higher the score, the more symptoms or problems (the lower the quality of life) .

  2. 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

    QLQ-OES18 is a module for assessing the quality of life of patients with esophageal cancer, which needs to be used together with the QLQ-C30 core questionnaire, with 18 items divided into 10 domains. The scoring method is as follows:

    For all items, score from 1 to 4 according to the answer options . Add up the scores of the items included in each domain and divide by the number of items included, to get the raw score of that domain .

    Use the range method to perform a linear transformation, converting the raw score into a standardized score between 0 and 100 .

    For functional domains and overall health status/quality of life domain, the higher the score, the better the functional status and quality of life; for symptom domains, the higher the score, the more symptoms or problems (the lower the quality of life) .

  3. 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

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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