Diverticulum, ColonREMADNCT03325829
Registro Malattia Diverticolare (Registry of Diverticular Disease)
An observational study of Diverticulum, Colon and Diverticulitis, run by Gruppo Italiano Malattia Diverticolare.
Trial summary
To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulum, Colon, Diverticulitis
- How many people
- 1,217 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2020
- How long will I take part?
- 5 Years
- 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
- Adult, Older adult
Study population: Adult patients with colonic diverticula
Who may be able to join
- All consecutive patients satisfying the following inclusion criteria are recruited:
- Acceptance to sign the Informed Consent form
- Age >18
- Instrumental evidence (endoscopic or radiological) of diverticula in the colon.
Who cannot join
- Refusal to sign the Informed Consent form
- Inability to comply with the study procedures
About this study
Official title: Diverticular Disease Register (REMAD)
To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population.
Read the detailed description
Diverticulosis and diverticular disease present a high prevalence rate in the world population, especially in the Western world. Diverticulosis of the colon is an extremely common condition in industrialized countries and its prevalence rate increases with age, and exceeds 60% in patients aged over eighty. Although the course of diverticulosis is normally free of symptoms and complications, about 15% of patients develop symptoms often undistinguishable from those of the irritable bowel syndrome, such as abdominal pain, bowel disorders and bloating. About 5% of patients with diverticular disease develop an episode of uncomplicated acute diverticulitis with abdominal symptoms accompanied in some cases by systemic symptoms, such as fever or malaise and laboratory evidence of activation of the inflammatory process. In a minority of these cases, the patient suffers major complications such as the development of abscesses, fistulae, haemorrhage or stenosis (1).
The pathogenesis of diverticulosis and diverticular disease remains unclear. Genetic predisposition, risk factors (2), relationships with the irritable bowel syndrome (3-5), a low-fibre diet, involvement of intestinal microbiota and the mucosal immune activation (6-7) remain elements whose significance is yet to be confirmed. The management, medical and surgical approach and the prevention of relapses of diverticular disease remain above all empirical and supported by few controlled clinical studies (8-9). This scenario of uncertainty may result in waste and diagnostic/therapeutic pathways not always suitable for a disease with such a high prevalence rate. On the basis of these considerations, there is a need to collect systematic information useful for determining aetiopathogenetic aspects and outcomes with greater accuracy.
OBJECTIVES OF THE STUDY
The purpose of the study is to structure a national register on an IT platform useful for determining:
- The clinical aspects of diverticulosis/ diverticular disease
- The risk factors of diverticulosis/ diverticular disease
- The risk of complications of diverticular disease and the factors of risk and protection against complications.
- The management of medical and surgical treatments
- Conditions
- Diverticulum, Colon, Diverticulitis
- Keywords
- Registry, Diverticular Disease, Diverticulitis, Uncomplicated Diverticular Disease
- Medical subject headings
- Diverticulum, Colon, Diverticulitis, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colonic diverticula | No interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors of diverticulosis/ diverticular disease
Evaluation of demographic and clinical characteristics, including comorbidities and co-treatment, able to characterize the subgroups of patients with diverticular disease
Measured: Five years
Secondary outcomes (1)
Risk of complications of diverticular disease and the factors of risk and protection against complications
To evaluate risk factors for occurrence and recurrence of diverticulitis
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startApr 2015
- Primary completionJun 2015
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diverticulum, ColonStudies 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
- 1,217 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattia Diverticolare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROSARIO CUOMO, Gruppo Italiano Malattia Diverticolare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325829
- Sponsor's protocol ID
- REMAD Registry
- Acronym
- REMAD
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Annibale B, Lahner E, Maconi G, Usai P, Marchi S, Bassotti G, Barbara G, Cuomo R. Clinical features of symptomatic uncomplicated diverticular disease: a multicenter Italian survey. Int J Colorectal Dis. 2012 Sep;27(9):1151-9. doi: 10.1007/s00384-012-1488-5. Epub 2012 May 10.
PubMed 22573184Cuomo R, Barbara G, Andreozzi P, Bassotti G, Casetti T, Grassini M, Ierardi E, Maconi G, Marchi S, Sarnelli G, Savarino V, Usai P, Vozzella L, Annibale B. Symptom patterns can distinguish diverticular disease from irritable bowel syndrome. Eur J Clin Invest. 2013 Nov;43(11):1147-55. doi: 10.1111/eci.12152. Epub 2013 Sep 2.
PubMed 23992370Annibale B, Maconi G, Lahner E, De Giorgi F, Cuomo R. Efficacy of Lactobacillus paracasei sub. paracasei F19 on abdominal symptoms in patients with symptomatic uncomplicated diverticular disease: a pilot study. Minerva Gastroenterol Dietol. 2011 Mar;57(1):13-22.
PubMed 21372765Maconi G, Barbara G, Bosetti C, Cuomo R, Annibale B. Treatment of diverticular disease of the colon and prevention of acute diverticulitis: a systematic review. Dis Colon Rectum. 2011 Oct;54(10):1326-38. doi: 10.1097/DCR.0b013e318223cb2b.
PubMed 21904150Zullo A, Hassan C, Maconi G, Manes G, Tammaro G, De Francesco V, Annibale B, Ficano L, Buri L, Gatto G, Lorenzetti R, Campo SM, Ierardi E, Pace F, Morini S. Cyclic antibiotic therapy for diverticular disease: a critical reappraisal. J Gastrointestin Liver Dis. 2010 Sep;19(3):295-302.
PubMed 20922195Carabotti M, Marasco G, Sbarigia C, Cuomo R, Barbara G, Pace F, Sarnelli G, Annibale B; at behalf of REMAD group. Site and duration of abdominal pain discriminate symptomatic uncomplicated diverticular disease from previous diverticulitis patients. Intern Emerg Med. 2024 Aug;19(5):1235-1245. doi: 10.1007/s11739-024-03588-6. Epub 2024 Apr 27.
PubMed 38671294Cremon C, Carabotti M, Cuomo R, Pace F, Andreozzi P, Barbaro MR, Annibale B, Barbara G. Italian nationwide survey of pharmacologic treatments in diverticular disease: Results from the REMAD registry. United European Gastroenterol J. 2019 Jul;7(6):815-824. doi: 10.1177/2050640619845990. Epub 2019 Apr 20.
PubMed 31316786
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diverticular Disease Register (REMAD)
- ClinicalTrials.gov ID
- NCT03325829
- Acronym / sponsor ID
- REMAD / REMAD Registry
- Conditions
- Diverticulum, Colon, Diverticulitis
- Keywords
- Registry, Diverticular Disease, Diverticulitis, Uncomplicated Diverticular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,217 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattia DiverticolareUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2020 (estimated)
- First posted
- 30 Oct 2017 (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.
To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population.
Detailed description
Diverticulosis and diverticular disease present a high prevalence rate in the world population, especially in the Western world. Diverticulosis of the colon is an extremely common condition in industrialized countries and its prevalence rate increases with age, and exceeds 60% in patients aged over eighty. Although the course of diverticulosis is normally free of symptoms and complications, about 15% of patients develop symptoms often undistinguishable from those of the irritable bowel syndrome, such as abdominal pain, bowel disorders and bloating. About 5% of patients with diverticular disease develop an episode of uncomplicated acute diverticulitis with abdominal symptoms accompanied in some cases by systemic symptoms, such as fever or malaise and laboratory evidence of activation of the inflammatory process. In a minority of these cases, the patient suffers major complications such as the development of abscesses, fistulae, haemorrhage or stenosis (1).
The pathogenesis of diverticulosis and diverticular disease remains unclear. Genetic predisposition, risk factors (2), relationships with the irritable bowel syndrome (3-5), a low-fibre diet, involvement of intestinal microbiota and the mucosal immune activation (6-7) remain elements whose significance is yet to be confirmed. The management, medical and surgical approach and the prevention of relapses of diverticular disease remain above all empirical and supported by few controlled clinical studies (8-9). This scenario of uncertainty may result in waste and diagnostic/therapeutic pathways not always suitable for a disease with such a high prevalence rate. On the basis of these considerations, there is a need to collect systematic information useful for determining aetiopathogenetic aspects and outcomes with greater accuracy.
OBJECTIVES OF THE STUDY
The purpose of the study is to structure a national register on an IT platform useful for determining:
- The clinical aspects of diverticulosis/ diverticular disease
- The risk factors of diverticulosis/ diverticular disease
- The risk of complications of diverticular disease and the factors of risk and protection against complications.
- The management of medical and surgical treatments
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colonic diverticula | – | –No interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with colonic diverticula
Key inclusion criteria (4 listed)
- Acceptance to sign the Informed Consent form
- Age >18
- Instrumental evidence (endoscopic or radiological) of diverticula in the colon.
Key exclusion criteria (2 listed)
- Refusal to sign the Informed Consent form
- Inability to comply with the study procedures
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
Risk factors of diverticulosis/ diverticular disease
Time frame: Five years
Evaluation of demographic and clinical characteristics, including comorbidities and co-treatment, able to characterize the subgroups of patients with diverticular disease
1 secondary outcome
Risk of complications of diverticular disease and the factors of risk and protection against complications
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Background: PubMed 22573184Annibale B, Lahner E, Maconi G, Usai P, Marchi S, Bassotti G, Barbara G, Cuomo R. Clinical features of symptomatic uncomplicated diverticular disease: a multicenter Italian survey. Int J Colorectal Dis. 2012 Sep;27(9):1151-9. doi: 10.1007/s00384-012-1488-5. Epub 2012 May 10.
- Background: PubMed 23992370Cuomo R, Barbara G, Andreozzi P, Bassotti G, Casetti T, Grassini M, Ierardi E, Maconi G, Marchi S, Sarnelli G, Savarino V, Usai P, Vozzella L, Annibale B. Symptom patterns can distinguish diverticular disease from irritable bowel syndrome. Eur J Clin Invest. 2013 Nov;43(11):1147-55. doi: 10.1111/eci.12152. Epub 2013 Sep 2.
- Background: PubMed 21372765Annibale B, Maconi G, Lahner E, De Giorgi F, Cuomo R. Efficacy of Lactobacillus paracasei sub. paracasei F19 on abdominal symptoms in patients with symptomatic uncomplicated diverticular disease: a pilot study. Minerva Gastroenterol Dietol. 2011 Mar;57(1):13-22.
- Background: PubMed 21904150Maconi G, Barbara G, Bosetti C, Cuomo R, Annibale B. Treatment of diverticular disease of the colon and prevention of acute diverticulitis: a systematic review. Dis Colon Rectum. 2011 Oct;54(10):1326-38. doi: 10.1097/DCR.0b013e318223cb2b.
- Background: PubMed 20922195Zullo A, Hassan C, Maconi G, Manes G, Tammaro G, De Francesco V, Annibale B, Ficano L, Buri L, Gatto G, Lorenzetti R, Campo SM, Ierardi E, Pace F, Morini S. Cyclic antibiotic therapy for diverticular disease: a critical reappraisal. J Gastrointestin Liver Dis. 2010 Sep;19(3):295-302.
- Derived from this study: PubMed 38671294Carabotti M, Marasco G, Sbarigia C, Cuomo R, Barbara G, Pace F, Sarnelli G, Annibale B; at behalf of REMAD group. Site and duration of abdominal pain discriminate symptomatic uncomplicated diverticular disease from previous diverticulitis patients. Intern Emerg Med. 2024 Aug;19(5):1235-1245. doi: 10.1007/s11739-024-03588-6. Epub 2024 Apr 27.
- Derived from this study: PubMed 31316786Cremon C, Carabotti M, Cuomo R, Pace F, Andreozzi P, Barbaro MR, Annibale B, Barbara G. Italian nationwide survey of pharmacologic treatments in diverticular disease: Results from the REMAD registry. United European Gastroenterol J. 2019 Jul;7(6):815-824. doi: 10.1177/2050640619845990. Epub 2019 Apr 20.
Related trials for Diverticulum, Colon
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
RecruitingObservational study
Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Zenker Diverticulum, Polyp of Colon
RecruitingObservational study
Quality of Life and Surgery in Diverticular Disease
Diverticulitis Colon, Quality of Life
RecruitingObservational study
Single-Stapled Technique for Colorectal Anastomosis
Colorectal Cancer, Colorectal Anastomosis
Active, not recruitingObservational study
The Diverticulitis Study
Colonic Diverticulitis, Colorectal 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 Diverticulum, Colon and Diverticulitis, run by Gruppo Italiano Malattia Diverticolare.
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 4 inclusion and 2 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 30 Oct 2017. 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?
Risk factors of diverticulosis/ diverticular disease (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325829, which also lists 7 linked publications.
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 30 Oct 2017.