ColectomyNCT02596516
A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies
An observational study of Colectomy and Bile Acid and Salts, run by Meir Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colectomy, Bile Acid and Salts
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients palnned to undergo colon resection.
Who may be able to join
- Age above 18.
- Patients intended to undergo a colectomy for colonic cancer
- Patients willing and participate and able to sign an informed consent
Who cannot join
- 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
About this study
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.
- Conditions
- Colectomy, Bile Acid and Salts
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic bile acid content
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilan Kent, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596516
- Sponsor's protocol ID
- MMC-0249-15
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies
- ClinicalTrials.gov ID
- NCT02596516
- Acronym / sponsor ID
- MMC-0249-15
- Conditions
- Colectomy, Bile Acid and Salts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients palnned to undergo colon resection.
Key inclusion criteria (3 listed)
- Age above 18.
- Patients intended to undergo a colectomy for colonic cancer
- Patients willing and participate and able to sign an informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colonic bile acid content
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
Related trials for Colectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
RecruitingObservational study
Mesogastrium Metastasis in Colon Cancer
Colon Cancer
RecruitingObservational study
Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
Right Colectomy
Not yet recruitingObservational study
Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis
Right Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colectomy and Bile Acid and Salts, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic bile acid content (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.