LARS in Ovarian Cancer Patients | NCT04279080

Studies
LARS in Ovarian Cancer Patients

NCT04279080

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Feb 20, 2020Actual

Enrollment

125Actual

Phase

Not provided

Conditions

Low Anterior Resection Syndrome

Interventions

low anterior resection syndrome evaluation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2003Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Feb 16, 2020

First Submission Date that Met QC Criteria

Feb 18, 2020

First Posted Date

Feb 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2020

Last Update Posted Date

Feb 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Felix Harpain, Principle Investigator, M.D., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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".

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		rectal cancer patients	Other: low anterior resection syndrome evaluation
2		ovarian cancer patients	Other: low anterior resection syndrome evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low anterior resection syndrome evaluation	Other	evaluation of postoperative functional bowel outcome	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional bowel outcome after low anterior resection	low anterior resection syndrome score, questionnaire via telephone call or personal contact	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

low anterior resection because of ovarian or rectal cancer

Exclusion Criteria:

neoadjuvant or adjuvant radiotherapy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000094123	Low Anterior Resection Syndrome

Ancestor Terms

ID	Term
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided