Quality of Life Clinical Trial
Official title:
Quality of Life After Colorectal Surgery: A Prospective Study of Patients Compared With Their Spouses
Verified date | February 2021 |
Source | Ankara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses. The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision [n = 33], low anterior resection [n = 33], left hemicolectomy [n = 34]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18. The QoL of patients and that of their spouses changed following surgery for colorectal cancer. These changes were more significant among male patients' spouses.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 1, 2010 |
Est. primary completion date | November 1, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. curative surgery for colorectal adenocarcinoma 2. living with a spouse 3. aged over 18 years 4. Muslim faith. Exclusion Criteria: 1) Other primary malignant tumors 4) Additional complicating or disabling disease that necessitated nursing assistance (e.g., mental illness) 5) Chemo-radiotherapy within 8 weeks prior to the interview 6) Admittance to a hospital except for stoma closure during the study period (no interview during stoma closure) 7) Major morbidity (e.g., anastomotic leakage, abdominal sepsis, stoma-related problems, and intensive care unit transfer) 8) Evidence of disease recurrence or metastasis, which was determined at the time of follow-up interviews |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cihangir Akyol |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life of patients and spouses | Medical outcomes: 36-item short form health survey (SF-36)
The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS). |
In the preoperative period | |
Primary | Quality of Life of patients and spouses | Medical outcomes: 36-item short form health survey (SF-36)
The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS). |
postoperative 15th month | |
Primary | Disability of patients and spouses | The World Health Organization disability assessment schedule II (WHODAS-II)
The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). |
In the preoperative period | |
Primary | Disability of patients and spouses | The World Health Organization disability assessment schedule II (WHODAS-II)
The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). |
postoperative 15th month |
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