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

NCT ID: NCT01181557

Last Updated: 2010-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

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

Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rectal cancer with stoma

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

No interventions assigned to this group

rectal cancer without stoma

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

No interventions assigned to this group

anterior resection of rectum

patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Rectal cancer

Exclusion Criteria

* Age younger than 18 years
* History of psychiatric illness
* Preoperative radiotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role lead

Responsible Party

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Principal Investigators

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alberto vannelli, MD

Role: STUDY_DIRECTOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Milan, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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INT-D176768

Identifier Type: -

Identifier Source: org_study_id

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