DiverticulitisGISDICNCT01276886
Italian Study Group on Complicated Diverticulosis
An observational study of Diverticulitis, run by Gruppo Italiano per lo Studio della Diverticolite Complicata at 1 site in Italy.
Trial summary
Patients were recruited over a four year period from 1996 to 1999. Those admitted in the years 1996 and 1997 were retrospectively accrued from the clinical records, while patients treated between 1998 and 1999 patients were entered on the database prospectively on admission. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diverticulitis
- What is being tested?
- antibiotic and Colonic resection with or without stoma
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 1996to Dec 1999
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) either alone or in combination and/or by operative findings
Who may be able to join
- All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of:
- abdominal pain,
- leukocytosis (>11x109)
- fever >38°C and confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema)
- The CT criteria for the diagnosis included at least one of:
- a localized thickening (≥4 mm) of the colonic wall
Show all 22Show fewer
- signs of inflammation of the pericolic fat
- abscess
- extraluminal air
- extraluminal contrast
- The ultrasound criteria included at least two of:
- bowel wall thickening (>4 mm)
- diverticular inflammation
- pericolic fat edema
- intramural or pericolic inflammatory mass
- intramural fistula
- Water soluble contrast enema criteria included at least two of:
- segmental luminal narrowing
- a tethered mucosa
- a mass effect
- extravasation of contrast
- the presence of extraluminal air
Who cannot join
- inflammatory bowel disease
- irritable bowel syndrome
- colorectal cancer
- diseases precluding adequate follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Italian Study Group on Complicated Diverticulosis: The Natural History of Left-sided Acute Diverticulitis
Patients were recruited over a four year period from 1996 to 1999. Those admitted in the years 1996 and 1997 were retrospectively accrued from the clinical records, while patients treated between 1998 and 1999 patients were entered on the database prospectively on admission.
Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) either alone or in combination and/or by operative findings, entered the study. The CT criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or extraluminal contrast. The criteria for ultrasound included at least two of the following signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema, intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with or without a mass effect or extravasation of contrast and/or the presence of extraluminal air.
Read more
Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome, colorectal cancer or diseases precluding adequate follow up, were excluded from the study.
Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided abscess drainage) or surgically according to the local policy of each center.
Follow up Follow up was carried out according to local policy. The following data were collected: persistence or recurrence of chronic symptoms attributable to complicated diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment and outcome.
Recurrence was defined as a new episode of AD requiring hospitalization that occurred at least 2 months after complete resolution of the index episode which resulted in inclusion in the study. If surgery was performed, the timing, type of procedure, Hinchey stage and complications were recorded.
Data collection A standardized flow sheet was used to collect data on medical history, diagnostic work up, type of treatment and follow up to create a dedicated database. Gender, age, date of hospital admission and discharge, diagnosis on admission and discharge, co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal failure), symptoms experienced before admission and their duration, history of diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were recorded. Where surgery was performed, the date and type of procedure, the operative findings including Hinchey's classification (16) and details of the operation (incision, extension of resection, type of anastomosis, covering stoma, drains), pathology report, and postoperative complications occurring within 30 days, were all recorded.
End points The primary endpoint was to assess the rate of recurrence of AD requiring hospitalization during the follow-up period. Additional endpoints were to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up.
- Conditions
- Diverticulitis
- Being tested
- antibiotic, Colonic resection with or without stoma
- Keywords
- Left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging., CT criteria: localized thickening (≥4 mm) of the colonic wall and signs of inflammation of the pericolic fat, abscess and/or extraluminal air and/or contrast., US criteria: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema, intramural or pericolic inflammatory mass, intramural fistula., WSCE criteria: segmental luminal narrowing and a tethered mucosa with or without a mass effect or extravasation of contrast and/or extraluminal air.
- Medical subject headings
- Diverticulitis, Leukocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibioticDrug
Colonic resection with or without stomaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Acute Diverticulitis | Not described Receives: Drug: antibiotic; Procedure: Colonic resection with or without stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the rate of recurrence of acute diverticulitis requiring hospitalization during the follow-up period
Measured: 10 years
Secondary outcomes (1)
to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 1996
- Primary completionDec 1999
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies 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
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per lo Studio della Diverticolite Complicata
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276886
- Sponsor's protocol ID
- GISDIC-1
- Acronym
- GISDIC
- Status last verified
- Dec 2010
- First submitted
- 12 Jan 2011
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Study Group on Complicated Diverticulosis: The Natural History of Left-sided Acute Diverticulitis
- ClinicalTrials.gov ID
- NCT01276886
- Acronym / sponsor ID
- GISDIC / GISDIC-1
- Conditions
- Diverticulitis
- Keywords
- Left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging., CT criteria: localized thickening (≥4 mm) of the colonic wall and signs of inflammation of the pericolic fat, abscess and/or extraluminal air and/or contrast., US criteria: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema, intramural or pericolic inflammatory mass, intramural fistula., WSCE criteria: segmental luminal narrowing and a tethered mucosa with or without a mass effect or extravasation of contrast and/or extraluminal air.
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Gruppo Italiano per lo Studio della Diverticolite ComplicataUniversity, hospital or other
- Study start
- Jan 1996
- Primary completion
- Dec 1999 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 13 Jan 2011 (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.
Patients were recruited over a four year period from 1996 to 1999. Those admitted in the years 1996 and 1997 were retrospectively accrued from the clinical records, while patients treated between 1998 and 1999 patients were entered on the database prospectively on admission.
Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) either alone or in combination and/or by operative findings, entered the study. The CT criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or extraluminal contrast. The criteria for ultrasound included at least two of the following signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema, intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with or without a mass effect or extravasation of contrast and/or the presence of extraluminal air.
Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome, colorectal cancer or diseases precluding adequate follow up, were excluded from the study.
Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided abscess drainage) or surgically according to the local policy of each center.
Follow up Follow up was carried out according to local policy. The following data were collected: persistence or recurrence of chronic symptoms attributable to complicated diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment and outcome.
Recurrence was defined as a new episode of AD requiring hospitalization that occurred at least 2 months after complete resolution of the index episode which resulted in inclusion in the study. If surgery was performed, the timing, type of procedure, Hinchey stage and complications were recorded.
Data collection A standardized flow sheet was used to collect data on medical history, diagnostic work up, type of treatment and follow up to create a dedicated database. Gender, age, date of hospital admission and discharge, diagnosis on admission and discharge, co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal failure), symptoms experienced before admission and their duration, history of diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were recorded. Where surgery was performed, the date and type of procedure, the operative findings including Hinchey's classification (16) and details of the operation (incision, extension of resection, type of anastomosis, covering stoma, drains), pathology report, and postoperative complications occurring within 30 days, were all recorded.
End points The primary endpoint was to assess the rate of recurrence of AD requiring hospitalization during the follow-up period. Additional endpoints were to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Diverticulitis | – | Drug: antibiotic, Procedure: Colonic resection with or without stoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) either alone or in combination and/or by operative findings
Key inclusion criteria (22 listed)
- All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of:
- abdominal pain,
- leukocytosis (>11x109)
- fever >38°C and confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema)
- a localized thickening (≥4 mm) of the colonic wall
Key exclusion criteria (4 listed)
- inflammatory bowel disease
- irritable bowel syndrome
- colorectal cancer
- diseases precluding adequate follow up
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 |
|---|---|---|
| antibiotic | Drug | Acute Diverticulitis |
| Colonic resection with or without stoma | Procedure or surgery | Acute Diverticulitis |
Primary outcome
to assess the rate of recurrence of acute diverticulitis requiring hospitalization during the follow-up period
Time frame: 10 years
1 secondary outcome
to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up
Time frame: 10 years
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 24 Jan 2011.
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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 Diverticulitis, run by Gruppo Italiano per lo Studio della Diverticolite Complicata at 1 site in Italy.
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 22 inclusion and 4 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 24 Jan 2011. 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 Italy. 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?
to assess the rate of recurrence of acute diverticulitis requiring hospitalization during the follow-up period (time frame: 10 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 24 Jan 2011.