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NCT04279080 Clinical Trial

LARS in Ovarian Cancer Patients

Low Anterior Resection Syndrome Clinical Trial

Official title:
Low Anterior Resection Syndrome (LARS) in Ovarian Cancer Patients - a Multi-centre Comparative Analysis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04279080
Other study ID # 1201/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2003
Est. completion date December 31, 2018

Study information
Verified date February 2020
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Therefore, the study was designed to assess LARS in advanced epithelial ovarian cancer (EOC) patients, who underwent rectal resection and to compare it with a female rectal cancer cohort.

Methods:

A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen. None of the patients received pre- or postoperative radiotherapy. LARS was defined by using the validated LARS score and its severity was divided into "no", "minor" and "major LARS".

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- low anterior resection because of ovarian or rectal cancer

Exclusion Criteria:

- neoadjuvant or adjuvant radiotherapy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• low anterior resection syndrome evaluation
evaluation of postoperative functional bowel outcome

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Outcome
Type Measure Description Time frame Safety issue
Primary functional bowel outcome after low anterior resection low anterior resection syndrome score, questionnaire via telephone call or personal contact 1 year
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