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

Primary Purpose

Esophageal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cushion
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group 1

    Group 2

    Arm Description

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

    Routine nursing intervention

    Outcomes

    Primary Outcome Measures

    Reflux symptoms
    Reflux Diagnostic Questionnaire RDQ

    Secondary Outcome Measures

    Postoperative quality of life QLQ-C30
    European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30
    Postoperative quality of life QLQ-OES18
    European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18
    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

    Full Information

    First Posted
    August 28, 2022
    Last Updated
    September 13, 2022
    Sponsor
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05542680
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    October 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    134 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    In the intervention group, the special cushion for semi recumbent position was used
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Arm Description
    Routine nursing intervention
    Intervention Type
    Device
    Intervention Name(s)
    cushion
    Intervention Description
    In the intervention group, the special cushion for semi recumbent position was used
    Primary Outcome Measure Information:
    Title
    Reflux symptoms
    Description
    Reflux Diagnostic Questionnaire RDQ
    Time Frame
    1 to 30 days after surgery
    Secondary Outcome Measure Information:
    Title
    Postoperative quality of life QLQ-C30
    Description
    European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30
    Time Frame
    7 days after surgery
    Title
    Postoperative quality of life QLQ-OES18
    Description
    European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18
    Time Frame
    7 days after surgery
    Title
    Skin pressure injury
    Description
    The staging standard of pressure injury published by the national pressure sore Advisory Committee of the United States was applied to skin pressure injury
    Time Frame
    7 to 180 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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