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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01181557
Other study ID # INT-D176768
Secondary ID
Status Completed
Phase N/A
First received April 1, 2010
Last updated August 12, 2010
Start date September 2008
Est. completion date December 2009

Study information

Verified date July 2008
Source Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Rectal cancer

Exclusion Criteria:

- Age younger than 18 years

- History of psychiatric illness

- Preoperative radiotherapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Milan

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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