Diverticulosis, ColonicNCT05384925
Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
An observational study of Diverticulosis, Colonic and Abdominal Adhesion, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Background \& Aims: Abnormal colonic pressure profiles have been associated with an increased risk of colonic diverticulosis. A surgical history is a known risk factor for abdominal adhesions, and these may lead to increased intraluminal colonic pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulosis, Colonic, Abdominal Adhesion, Diverticulitis
- What is being tested?
- comparison
- How many people
- 359 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Apr 2020to 1 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients 18 years of age and older presenting for a colonoscopy at Shamir Medical Center between 2020 and 2021
Who may be able to join
- patients > 18 years old who are going through colonoscopy in shamir medical center for any reason
Who cannot join
- inadequate preparation (Boston Bowel Preparation Quality Scale <6);
- previous colonic resection based on history and colonoscopy;
- previous colon cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Background \& Aims:
Abnormal colonic pressure profiles have been associated with an increased risk of colonic diverticulosis. A surgical history is a known risk factor for abdominal adhesions, and these may lead to increased intraluminal colonic pressure. We assessed whether previous abdominal surgery is associated with colonic diverticulosis or diverticulitis.
Methods:
The investigators analyzed data from a prospective study of patients undergoing colonoscopy for different indications from 2020 through 2021. Patients completed a structured questionnaire concerning previous abdominal surgeries, dietary and lifestyle exposures including smoking and alcohol use, and co-morbidities.
- Conditions
- Diverticulosis, Colonic, Abdominal Adhesion, Diverticulitis
- Being tested
- comparison
- Medical subject headings
- Diverticulosis, Colonic, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparisonOther
abdominal surgery as a risk factor for diverticulosis
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between prior abdominal surgery and the development of diverticulosis
the investigators are willing to see if prior abdominal surgery raise the patient's risk of developing future diverticulosis. The investigators use questionere to collect data from patients. The final measurements will be calculatrd with spss software
Measured: in the end of the study (estimated in 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start12 Apr 2020
- Primary completion22 May 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulosis, ColonicStudies 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
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eran Ariam, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384925
- Sponsor's protocol ID
- 0107-20
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
- ClinicalTrials.gov ID
- NCT05384925
- Acronym / sponsor ID
- 0107-20
- Conditions
- Diverticulosis, Colonic, Abdominal Adhesion, Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 20 May 2022 (actual)
- 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.
Background \& Aims:
Abnormal colonic pressure profiles have been associated with an increased risk of colonic diverticulosis. A surgical history is a known risk factor for abdominal adhesions, and these may lead to increased intraluminal colonic pressure. We assessed whether previous abdominal surgery is associated with colonic diverticulosis or diverticulitis.
Methods:
The investigators analyzed data from a prospective study of patients undergoing colonoscopy for different indications from 2020 through 2021. Patients completed a structured questionnaire concerning previous abdominal surgeries, dietary and lifestyle exposures including smoking and alcohol use, and co-morbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients 18 years of age and older presenting for a colonoscopy at Shamir Medical Center between 2020 and 2021
Key inclusion criteria (1 listed)
- patients > 18 years old who are going through colonoscopy in shamir medical center for any reason
Key exclusion criteria (3 listed)
- inadequate preparation (Boston Bowel Preparation Quality Scale <6);
- previous colonic resection based on history and colonoscopy;
- previous colon cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparisonabdominal surgery as a risk factor for diverticulosis | Other | – |
Primary outcome
correlation between prior abdominal surgery and the development of diverticulosis
Time frame: in the end of the study (estimated in 1 year)
the investigators are willing to see if prior abdominal surgery raise the patient's risk of developing future diverticulosis. The investigators use questionere to collect data from patients. The final measurements will be calculatrd with spss software
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulosis, Colonic and Abdominal Adhesion, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation between prior abdominal surgery and the development of diverticulosis (time frame: in the end of the study (estimated in 1 year)). 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 26 May 2022.