NCT03211715

Brief Summary

In contemporary era of rectal cancer treatment, development of surgical technique and tool, adaptation of chemoradiation therapy, as well as multidisciplinary approach have led increased survival as well as rate of sphincter preservation. However, poor anorectal function, such as fecal incontinence and/or urgency, has also been increased. Such anorectal dysfunction is named as low anterior resection syndrome, and its rate has been reported in 40 to 90% in rectal cancer patients who received sphincter preserving surgery. Low anterior resection syndrome is known to debilitate quality of life in survivors of rectal cancer. Previously, several studies attempted to evaluate the low anterior resection syndrome via questionnaires and scoring system. Adapting the low anterior resection syndrome score system created in Denmark, this study investigates the validity of the scoring system in Korean language.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Status
unknown

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

First Submitted

Initial submission to the registry

June 20, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

July 19, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

June 20, 2017

Last Update Submit

July 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life in association to the severity of bowel dysfunction

    The change in the quality of life will be evaluated based on the questionnaire in regard to bowel dysfunction

    3 months follow-up, 6 months follow-up, 1 year follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, beyond 5 year follow-up

Interventions

Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rectal cancer patients who underwent sphincter preserving surgery from Jan. 2009 to Dec. 2016 will be included. Patients who are in use of stoma despite of preserved sphincter, are with recurrent disease, or in systemic metastasis, who underwent emergency surgery will not be included.

You may qualify if:

  • age 20-80
  • surgery undertook from Jan. 2009 to Dec. 2016
  • diagnosed with adenocarcinoma
  • curative intent of surgery
  • planned surgery
  • sphincter saving surgery

You may not qualify if:

  • patients with stage IV
  • emergency surgery
  • patients with recurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.

    PMID: 24819098BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Hyungjin Kim, MD, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 20, 2017

First Posted

July 7, 2017

Study Start

July 19, 2017

Primary Completion

July 19, 2018

Study Completion

December 31, 2018

Last Updated

July 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share