NCT02596516

Brief Summary

The aim of this study is to evaluate whether there is a difference in the bile acid content in the bowel in patients after right versus left colectomy. There is compelling evidence that patients under going resection of the right colon versus left coolon have a lower polyp detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of patients undergoing left and right colectomies; prior to their surgery and again three and six months aftet the surgery. The investigators plan to compare the content of the different bile acids and to compare the content between the two groups.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

November 2, 2015

Last Update Submit

November 5, 2015

Conditions

ColectomyBile Acid and Salts

Outcome Measures

Primary Outcomes (1)

  • Colonic bile acid content

    two years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients palnned to undergo colon resection.

You may qualify if:

  • Age above 18.
  • Patients intended to undergo a colectomy for colonic cancer
  • Patients willing and participate and able to sign an informed consent

You may not qualify if:

  • Age under 18.
  • Patients with Inflammatory Bowel Disease (Crohn's, Ulcerative colitis).
  • Patients refusing to participate or are unable to understand or sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 4, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

December 1, 2020

Last Updated

November 6, 2015

Record last verified: 2015-11