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

NCT05542680 | Completed

• 1 other identifier: NCC2021C-266
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
2. 2.to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Reflux symptoms

  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

  1 to 30 days after surgery

Secondary Outcomes (3)

• Postoperative quality of life QLQ-C30

  7 days after surgery

• Postoperative quality of life QLQ-OES18

  7 days after surgery

• Skin pressure injury

  7 to 180 days after surgery

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: cushion

Group 2

NO INTERVENTION

Routine nursing intervention

Interventions

cushion DEVICE

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

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• cognitive impairment or mental illness;
• complicated with other serious diseases;
• unwilling to participate in this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Denture Liners

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 15, 2022
• Study Start: September 30, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 30, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)