A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

Study Overview
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Brief Summary
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The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia. Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.

Detailed Description
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Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy. Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients

Official Title
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Prospective Evaluation of Quality of Life in Patient With Rectal Cancer

Conditions
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Rectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectal cancer Exclusion Criteria: Age younger than 18 years History of psychiatric illness Preoperative radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rectal cancer with stoma<br>rectal cancer submitted to rectal anterior resection with stomia (RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month after stoma reconversion | |
| rectal cancer without stoma<br>rectal cancer submitted to rectal anterior resection (RAR) Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later | |
| anterior resection of rectum<br>patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma | Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS. | three month: first admission in hospital preoperative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma | Two cohort in postoperative time (three months after surgical procedure): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS. | Three months postoperative time | 
| Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma | Two cohort in postoperative time (six months after postoperative time): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS. | Six months after postoperative time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life