NCT04279080

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".

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

16 years

First QC Date

February 16, 2020

Last Update Submit

February 18, 2020

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

  • functional bowel outcome after low anterior resection

    low anterior resection syndrome score, questionnaire via telephone call or personal contact

    1 year

Study Arms (2)

1

rectal cancer patients

Other: low anterior resection syndrome evaluation

2

ovarian cancer patients

Other: low anterior resection syndrome evaluation

Interventions

low anterior resection syndrome evaluationOTHER

evaluation of postoperative functional bowel outcome

12

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • low anterior resection because of ovarian or rectal cancer

You may not qualify if:

  • neoadjuvant or adjuvant radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, M.D.

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 20, 2020

Study Start

January 1, 2003

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02