DiverticulitisNCT01015378
Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study
An observational study of Diverticulitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Aim: This is a longitudinal cohort study to assess long-term clinical outcome of patients who were admitted in our institution for a first episode of uncomplicated sigmoid diverticulitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- laparoscopid sigmoid resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Jan 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cohort study is designed in order to detect recurrent episodes of diverticulitis in a population of patients who were previously admitted in our institution for a first episode. 4.1. Study population The cohort will consist in the population of patients with CT-scan demonstrated, endoscopy-proven sigmoid diverticulitis who will be admitted in the Department of Surgery of the University Hospital Geneva from January 1st, 2010 to December 31st, 2019. At baseline, participants are between the ages of 18 and 90, and medical information will be updated every year until the end of follow-up, which is December 31st, 2020.
4.2. Inclusion criteria
- Informed consent
- A first episode of uncomplicated diverticulitis (see definitions), which was documented with CT scan, required hospital admission, and was successfully managed with intravenous antibiotics Or
- A first episode of complicated diverticulitis (Hinchey I or II - see definition), requiring CT scan-guided percutaneous drainage, and successfully managed without surgery in a patient either unfit for, or refusing to undergo elective sigmoid resection Exclusion criteria
- Age < 18 or > 90
- Associated condition of the colon or rectum (cancer, IBD, polyps)
- Patient unable to communicate in French, English or German
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Geneva
Geneva, 1211
Beatrice Konrad, beatrice.mugnier-konrad@hcuge.ch
Pascal Gervaz, MD
About this study
Aim: This is a longitudinal cohort study to assess long-term clinical outcome of patients who were admitted in our institution for a first episode of uncomplicated sigmoid diverticulitis.
Methods: All patients who were diagnosed with a first episode of sigmoid diverticulitis will be evaluated for inclusion in the study, pending informed consent. Those patients who have evidence of complicated diverticulitis (fistula, abscess) will receive a recommendation to undergo elective sigmoid resection, while those who have a simple attack will be recruited in the cohort. Follow-up will be performed at yearly intervals through telephone interview with the patient. The duration of study is expected to last 10 years (2010-2020), with >50 new patients/year, for a total of >500 patients.
Read more
Endpoints:
- the occurrence of a second episode of diverticulitis
- severity and outcome of recurrent diverticulitis
- evolution in digestive symptoms and quality of life (QoL)
- need for subsequent elective or emergency sigmoid resection
Rationale: This study will help in determining the risk/benefit of the current approach for this common condition, which is to manage patients conservatively with antibiotics and adopt a wait-and-see attitude. Specifically, the following events will be assessed quantitatively:
- the rate of relapse in an urban community.
- the burden of this common disease on QoL and digestive function
- the percentage of patients who may need emergency surgery
Read the detailed description
Colonic diverticulosis is an increasingly common condition in the Western societies; in our country, a third of the population is affected by the 6th decade and two-thirds by the 9th decade. Fortunately, a majority of patients with diverticulosis remain asymptomatic; diverticulitis, the most common presentation of diverticular disease, has an estimated incidence of 10 patients per 100,000/year.
The diagnosis of sigmoid diverticulitis is usually suspected clinically in a patient presenting with acute lower abdominal pain, associated with an inflammatory syndrome with elevated CRP and/or leukocytes count. The preferred imaging modality to establish definitive diagnosis is computerized tomography (CT) scan with triple (oral, intravenous and intra-rectal) administration of contrast. CT scan may also influence management by demonstrating whether sigmoid diverticulitis is simple (phlegmonous, showing an infiltration of pericolic fat and a thickening of intestinal wall) or complicated (abscess, fistula or peritonitis).
A majority of patients present with simple diverticulitis, and will be conservatively and successfully managed with antibiotics alone. Full colonoscopy is performed eventually, in order to rule out an associated condition, most notably cancer and Crohn's disease. Colonic diverticular disease is usually restricted to the sigmoid colon, and conservative treatment with antibiotics is indicated in cases of a first attack of uncomplicated diverticulitis, the rationale being that a majority of patients treated for a first episode of acute inflammation will eventually recover and have no further problems.
Elective sigmoidectomy is currently recommended in the following clinical situations:
- Patients who had two episodes of uncomplicated diverticulitis.
- Patients who had one episode of complicated (perforated) diverticulitis, with either pericolic of pelvic abscesses (Hinchey stage I and II respectively), fistula formation and/or stenosis.
These guidelines, however, reflect expert consensus rather than scientific evidence; currently, there is no way to predict for each patient the risk for developing subsequent complications and recurrences. Thus, the important question is to determine whether a conservative approach is not simply delaying definitive treatment and expose patients to additional complications and alterations in quality of life.
- OBJECTIVES
The main objective of this study is to assess the natural history of sigmoid diverticulitis in a cohort of patients living in an urban community, who had radiological and endoscopic evidence of diverticular disease, who benefited initially from adequate antibiotherapy, received dietary counselling, and were followed for a long period of time. In order to do that, we will assess prospectively the following variables:
3.1. Primary endpoints
- Annual rate of recurrent diverticulitis
- Severity and timing of recurrent episodes
- Quality of Life and gastrointestinal symptoms assessed with the GIQLI questionnaire
3.2. Secondary endpoints
- Risk for undergoing emergency surgery
- Surgical morbidity/mortality
- Conditions
- Diverticulitis
- Being tested
- laparoscopid sigmoid resection
- Keywords
- Recurrent sigmoid diverticulitis, diverticulitis, Colon, sigmoid, recurrence
- Medical subject headings
- Diverticulitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopid sigmoid resectionProcedure or surgery
A second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests
| Study group | Role | What they receive |
|---|---|---|
| Diverticulitis of the sigmoid colon - first episode | Not described Receives: Procedure: laparoscopid sigmoid resection |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2012 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015378
- Sponsor's protocol ID
- CODIGE
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Scarpa CR, Buchs NC, Poncet A, Konrad-Mugnier B, Gervaz P, Morel P, Ris F. Short-term Intravenous Antibiotic Treatment in Uncomplicated Diverticulitis Does Not Increase the Risk of Recurrence Compared to Long-term Treatment. Ann Coloproctol. 2015 Apr;31(2):52-6. doi: 10.3393/ac.2015.31.2.52. Epub 2015 Apr 30.
PubMed 25960972Buchs NC, Konrad-Mugnier B, Jannot AS, Poletti PA, Ambrosetti P, Gervaz P. Assessment of recurrence and complications following uncomplicated diverticulitis. Br J Surg. 2013 Jun;100(7):976-9; discussion 979. doi: 10.1002/bjs.9119. Epub 2013 Apr 17.
PubMed 23592303
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study
- ClinicalTrials.gov ID
- NCT01015378
- Acronym / sponsor ID
- CODIGE
- Conditions
- Diverticulitis
- Keywords
- Recurrent sigmoid diverticulitis, diverticulitis, Colon, sigmoid, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 Nov 2009 (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.
Aim: This is a longitudinal cohort study to assess long-term clinical outcome of patients who were admitted in our institution for a first episode of uncomplicated sigmoid diverticulitis.
Methods: All patients who were diagnosed with a first episode of sigmoid diverticulitis will be evaluated for inclusion in the study, pending informed consent. Those patients who have evidence of complicated diverticulitis (fistula, abscess) will receive a recommendation to undergo elective sigmoid resection, while those who have a simple attack will be recruited in the cohort. Follow-up will be performed at yearly intervals through telephone interview with the patient. The duration of study is expected to last 10 years (2010-2020), with >50 new patients/year, for a total of >500 patients.
Endpoints:
- the occurrence of a second episode of diverticulitis
- severity and outcome of recurrent diverticulitis
- evolution in digestive symptoms and quality of life (QoL)
- need for subsequent elective or emergency sigmoid resection
Rationale: This study will help in determining the risk/benefit of the current approach for this common condition, which is to manage patients conservatively with antibiotics and adopt a wait-and-see attitude. Specifically, the following events will be assessed quantitatively:
- the rate of relapse in an urban community.
- the burden of this common disease on QoL and digestive function
- the percentage of patients who may need emergency surgery
Detailed description
Colonic diverticulosis is an increasingly common condition in the Western societies; in our country, a third of the population is affected by the 6th decade and two-thirds by the 9th decade. Fortunately, a majority of patients with diverticulosis remain asymptomatic; diverticulitis, the most common presentation of diverticular disease, has an estimated incidence of 10 patients per 100,000/year.
The diagnosis of sigmoid diverticulitis is usually suspected clinically in a patient presenting with acute lower abdominal pain, associated with an inflammatory syndrome with elevated CRP and/or leukocytes count. The preferred imaging modality to establish definitive diagnosis is computerized tomography (CT) scan with triple (oral, intravenous and intra-rectal) administration of contrast. CT scan may also influence management by demonstrating whether sigmoid diverticulitis is simple (phlegmonous, showing an infiltration of pericolic fat and a thickening of intestinal wall) or complicated (abscess, fistula or peritonitis).
A majority of patients present with simple diverticulitis, and will be conservatively and successfully managed with antibiotics alone. Full colonoscopy is performed eventually, in order to rule out an associated condition, most notably cancer and Crohn's disease. Colonic diverticular disease is usually restricted to the sigmoid colon, and conservative treatment with antibiotics is indicated in cases of a first attack of uncomplicated diverticulitis, the rationale being that a majority of patients treated for a first episode of acute inflammation will eventually recover and have no further problems.
Elective sigmoidectomy is currently recommended in the following clinical situations:
- Patients who had two episodes of uncomplicated diverticulitis.
- Patients who had one episode of complicated (perforated) diverticulitis, with either pericolic of pelvic abscesses (Hinchey stage I and II respectively), fistula formation and/or stenosis.
These guidelines, however, reflect expert consensus rather than scientific evidence; currently, there is no way to predict for each patient the risk for developing subsequent complications and recurrences. Thus, the important question is to determine whether a conservative approach is not simply delaying definitive treatment and expose patients to additional complications and alterations in quality of life.
- OBJECTIVES
The main objective of this study is to assess the natural history of sigmoid diverticulitis in a cohort of patients living in an urban community, who had radiological and endoscopic evidence of diverticular disease, who benefited initially from adequate antibiotherapy, received dietary counselling, and were followed for a long period of time. In order to do that, we will assess prospectively the following variables:
3.1. Primary endpoints
- Annual rate of recurrent diverticulitis
- Severity and timing of recurrent episodes
- Quality of Life and gastrointestinal symptoms assessed with the GIQLI questionnaire
3.2. Secondary endpoints
- Risk for undergoing emergency surgery
- Surgical morbidity/mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diverticulitis of the sigmoid colon - first episode | – | Procedure: laparoscopid sigmoid resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort study is designed in order to detect recurrent episodes of diverticulitis in a population of patients who were previously admitted in our institution for a first episode. 4.1. Study population The cohort will consist in the population of patients with CT-scan demonstrated, endoscopy-proven sigmoid diverticulitis who will be admitted in the Department of Surgery of the University Hospital Geneva from January 1st, 2010 to December 31st, 2019. At baseline, participants are between the ages of 18 and 90, and medical information will be updated every year until the end of follow-up, which is December 31st, 2020.
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 |
|---|---|---|
| laparoscopid sigmoid resectionA second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests | Procedure or surgery | Diverticulitis of the sigmoid colon - first episode |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
- Derived from this study: PubMed 25960972Scarpa CR, Buchs NC, Poncet A, Konrad-Mugnier B, Gervaz P, Morel P, Ris F. Short-term Intravenous Antibiotic Treatment in Uncomplicated Diverticulitis Does Not Increase the Risk of Recurrence Compared to Long-term Treatment. Ann Coloproctol. 2015 Apr;31(2):52-6. doi: 10.3393/ac.2015.31.2.52. Epub 2015 Apr 30.
- Derived from this study: PubMed 23592303Buchs NC, Konrad-Mugnier B, Jannot AS, Poletti PA, Ambrosetti P, Gervaz P. Assessment of recurrence and complications following uncomplicated diverticulitis. Br J Surg. 2013 Jun;100(7):976-9; discussion 979. doi: 10.1002/bjs.9119. Epub 2013 Apr 17.
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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.
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 Diverticulitis, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Jun 2010. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015378, which also lists 2 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 25 Jun 2010.