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Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients

Primary Purpose

Rehabilitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation with stoma appliance
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients undergoing elective operable colorectal resections that would require the formation of a temporary or permanent stoma. Patients who were likely to be self-sufficient in managing their stoma pouching system after surgery. Exclusion Criteria: Those who undergo emergency surgery Disoriented patients who cannot cooperate. Patients with psychiatric disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    standard postoperative education.

    preoperative rehabilitation group

    Arm Description

    These patients will receive stoma care and stoma education beginning on postoperative day1.

    The rehabilitation group will receive preoperative stoma education in addition

    Outcomes

    Primary Outcome Measures

    duration of hospital stay
    Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.

    Secondary Outcome Measures

    Assess anxiety and depression
    Assess anxiety and depression according to HADS (Hospital Anxiety and Depression Scale). 0-7 normal 8-10 border line abnormal 11-21 abnormal
    assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
    Assess the quality of life of those patients including physical, social/family, emotional, functional wellbeing, using FACT-C version 4 (Functional Assessment of Cancer Therapy-Colorectal) questionnaire. recall period past 7 days response scale 5point Likert-type scale total a FACT-C score (functional assessment of cancer therapy -colorectal) range 0-136 the higher the score the better the quality of life

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05958433
    Brief Title
    Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients
    Official Title
    Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients, A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, controlled trial aiming to assess the effects of preoperative education using stoma appliance on stoma self-care, quality of life, anxiety, and depression levels in colorectal cancer patients with a stoma.
    Detailed Description
    Colorectal cancer is third cancer worldwide after breast and lung cancer accounting for 10% of all cancer cases and 9.4% of cancer deaths. Over 2.2 million new colorectal cancer cases and 1.8 million deaths have been estimated to occur in 2020. In Egypt, it is the seventh cancer, accounting for 3.9% of all cancers, with about 5,000 new cases annually. Colorectal resections are often associated with temporary or permanent stoma formations. In the United Kingdom it is estimated that more than 20,000 new stomas are created each year, 11,800 of them were colostomies. About one-half of the stoma was permanent. The formation of a stoma is associated with psychologic morbidity, which can be reduced with preoperative and postoperative patient education and psychologic support. Living with a stoma is a challenging situation for various reasons including uncontrolled gas passage through it, diarrhea, odor, and leakage around the stoma or appliance. It would take several months for the patients to adjust to this difficult time. At that point, the patient's Quality of life becomes essential for the remaining time. Ostomy formation is one of the therapeutic procedures performed to manage bowel dysfunction due to various reasons; however, it affects quality of life of patients. World health organization defines QOL as an individual's perspective of his/her health status concerning a few aspects- physical, psychological, economic, social, and environmental. A stoma influences the physical, mental, emotional, and social life of the patient significantly. A good quality of life is essential to achieve a comprehensive approach to treating patients. A study done in China to assess stoma related quality of life using a stoma self-care agency scale and health hope index showed that patients had difficulties in work and social institutions. Additional concerns pointed out were sexuality, body image and the stoma itself. A long-term effect on the quality of life of members of the United Ostomy Association of America after 5 years of ostomy surgery was assessed using a questionnaire. Their report has shown that patients feel better as they live longer with the stoma. Research done on Iranian by ostomy society has shown that factors such as the type of ostomy, the underlying disease that had led to the stoma formation, depression after ostomy, dissatisfaction with sexual activities, a problem with the location of ostomy and change in clothing style affected the Quality of Life. Ostomies can lead to intensified distress and suffering in patients because of skin irritation (76%), pouch leakage (62%), offensive odor (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). In such circumstances, it is worthwhile to assess the quality of life in the evaluation of the outcomes of various therapeutic procedures along with their final impact on patients' lives. Quality of care and training provided to patients can be associated with their subsequent quality of life. The main aim of this study is to assess the effects of preoperative education on stoma self-care, quality of life, Anxiety, and depression levels in colorectal cancer patients with a stoma.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standard postoperative education.
    Arm Type
    Active Comparator
    Arm Description
    These patients will receive stoma care and stoma education beginning on postoperative day1.
    Arm Title
    preoperative rehabilitation group
    Arm Type
    Experimental
    Arm Description
    The rehabilitation group will receive preoperative stoma education in addition
    Intervention Type
    Behavioral
    Intervention Name(s)
    Rehabilitation with stoma appliance
    Intervention Description
    The rehabilitation group will receive preoperative stoma education in addition, a water-filled ostomy appliance (50-100 ml) will be attached 48 hours before surgery. These pouches will not be removed until surgery, and the EST nurse will teach the patients preoperatively how to manage the ostomy appliance with similar standards as described in the usual postoperative stoma care.
    Primary Outcome Measure Information:
    Title
    duration of hospital stay
    Description
    Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Assess anxiety and depression
    Description
    Assess anxiety and depression according to HADS (Hospital Anxiety and Depression Scale). 0-7 normal 8-10 border line abnormal 11-21 abnormal
    Time Frame
    9 monthes
    Title
    assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
    Description
    Assess the quality of life of those patients including physical, social/family, emotional, functional wellbeing, using FACT-C version 4 (Functional Assessment of Cancer Therapy-Colorectal) questionnaire. recall period past 7 days response scale 5point Likert-type scale total a FACT-C score (functional assessment of cancer therapy -colorectal) range 0-136 the higher the score the better the quality of life
    Time Frame
    11 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing elective operable colorectal resections that would require the formation of a temporary or permanent stoma. Patients who were likely to be self-sufficient in managing their stoma pouching system after surgery. Exclusion Criteria: Those who undergo emergency surgery Disoriented patients who cannot cooperate. Patients with psychiatric disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nora gouda, lecturer
    Phone
    01005627897
    Email
    noraatef148@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doaa Wadie, Proffesor
    Phone
    01223703067
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nelly AliEldien, proffesor
    Organizational Affiliation
    Prof. Biostatistics & Cancer Epidemiology National Cancer Institute, Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    33538338
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    Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients

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