NCT02139475

Brief Summary

The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Through this, ultimately in patients with a history of colorectal cancer who have high risk of colorectal cancer, it could be possible to detect cancerous lesions early and increase the survival rate. This study is based on observational study Subjects are the patients with colorectal cancer surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical records on the basis of information collected at the point of the colonoscopy performed Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient compliance and satisfaction are measured.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 29, 2019

Status Verified

December 1, 2017

Enrollment Period

3.2 years

First QC Date

May 13, 2014

Last Update Submit

March 27, 2019

Conditions

Keywords

bowel cleansing, colorectal cancer surgery

Outcome Measures

Primary Outcomes (1)

  • Boston bowel preparation scale (BBPS)

    In this scale, the colon is divided in three segments: the right side (including cecum and ascending colon), the transverse colon (including the flexures) and the left sided colon, which includes the descending colon, sigmoid and rectum. Mucosal view should be scored after cleansing maneuvers like suctioning or washing have been performed. For all three sections cleansing is assessed and given a score ranging from 0 to 3. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. BBPS score ≥6 in considered an adequate bowel preparation.

    1 hour

Study Arms (1)

Colonoscopy

patients undergoing colonoscopy after colorectal cancer surgery

Procedure: Colonoscopy

Interventions

ColonoscopyPROCEDURE
Colonoscopy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing colonoscopy after colorectal cancer surgery

You may qualify if:

  • age ≥ 20
  • patients who underwent colorectal cancer surgery
  • patients who underwent follow-up colonoscopy as a conventional medical procedures

You may not qualify if:

  • age \< 20
  • patients who have ileus or bowel obstruction
  • patients in pregnant status
  • Patients who did not consent to research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 15, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 29, 2019

Record last verified: 2017-12

Locations