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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05542680
Collaborator
(none)
134
2
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cushion
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

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

No Intervention: Group 2

Routine nursing intervention

Outcome Measures

Primary Outcome Measures

  1. Reflux symptoms [1 to 30 days after surgery]

    Reflux Diagnostic Questionnaire RDQ

Secondary Outcome Measures

  1. Postoperative quality of life QLQ-C30 [7 days after surgery]

    European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30

  2. Postoperative quality of life QLQ-OES18 [7 days after surgery]

    European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18

  3. Skin pressure injury [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  3. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05542680
Other Study ID Numbers:
  • NCC2021C-266
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022