Colonic DiverticulitisDDRNCT04907383
Prospective Evaluation of Quality of Life in Patients With Acute Colonic Diverticular Disease
An observational study of Colonic Diverticulitis, run by Niguarda Hospital at 1 site in Italy.
Trial summary
A multicenter prospective observational study. Aim of the study is to identify the clinical parameters correlating with favorable outcomes in patients undergoing surgery or medical treatment for diverticular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diverticulitis
- What is being tested?
- quality of life
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 1 Dec 2023
- How long will I take part?
- 1 Year
- 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: All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection. All patients diagnosed with left-side colonic diverticulitis who are treated in one of the participating hospitals will be asked to participate in this cohort study. The sample size will be that obtained at the end of the 5 years of recruitment. From January 2010 to December 2019, a mean number of 26 patients per year have been operated on for diverticular disease among each of the centers involved in the study. Thus, giving a total recruiting capacity of 78 patients per year, nearly 400 patients are expected to be enrolled in a 5 years' time period.
Who may be able to join
- imaging-proven colonic diverticular disease
- patient aged > 18 years old
- Written informed consent obtained
- A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible
- Patients undergoing surgical or medical treatment will be enrolled in the registry and undergo a 36-months follow up period.
Who cannot join
- < 18 yo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Quality of Life in Patients With Acute Colonic Diverticular Disease: Diverticular Disease Registry DDR Trial
A multicenter prospective observational study. Aim of the study is to identify the clinical parameters correlating with favorable outcomes in patients undergoing surgery or medical treatment for diverticular disease. The primary aim is be the assessment of quality of life of theses patients according to the GIQLY score at 1 year from the enrollment in the registry. Patients will be enrolled in a prospective study and followed for 36 months after the diagnosis of acute diverticulitis. All participating centres are tertiary hospitals located in Europe .
Read the detailed description
All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection.
Inclusion criteria: 1) imaging-proven colonic diverticular disease 2) patient aged > 18 years old; 3) Written informed consent obtained. 4) A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible Demographic and functional data will be recorded during the first surgical visit, together with a complete clinical examination. Data regarding the symptoms of presentation and quality of life will be collected and categorized. Comorbidity Index adjusted for age will be calculated for every patient, while those >70 years old will be assessed for frailty risk using the modified Frailty Index (mFI) described by Robinson et al. Relevant medications will be listed.
Setting, (emergency room vs outpatients clinic), need for admission, treatment, emergency surgery vs delayed elective surgery vs only medical management (including percutaneous drain placement) will be recorded.
Intraoperative parameters will be recorded in the registry both for emergency procedures and elective procedures, including several technical aspects such as level of inferior mesenteric artery ligtion, type of energy device used, number and type of stapler cartridge, size of circular stapler,. Use of the laparoscopy technique, conversion rate, peritoneal lavage, surgical second look will be recorded.
Histopathological examination will be recorded in terms of length of the specimen, the presence of microscopic or macroscopic abscesses, the presence of Crohn's like reaction or of lymphocyte infiltration and the eventual presence of unknown cancer.
Post-operative complications will be reported according to the Clavien-Dindo classification 15. Length of stay and post-discharge complications will be evaluated and recorded. Application of Enhanced recovery protocols will be considered only for at least 80% of the designed colo-rectal items will be satisfied.
One investigator in each center will be responsible for the follow up data. Functional follow up will be done yearly according to the GIQLY, FSFI, IIEF, ICIQ, IPSS questionnaires.
Data will be prospectively collected using a REDCAP database by the site principal investigator for each hospital. Quarterly meetings will be set between the study coordinators and the participating centers. A data manager (GP) will regularly control the quality of the data provided
- Conditions
- Colonic Diverticulitis
- Being tested
- quality of life
- Keywords
- Diverticular disease, Acute diverticulitis, Emergency surgery, Prospective observational study
- Medical subject headings
- Diverticulitis, Colonic, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeOther
QoL assessment
| Study group | Role | What they receive |
|---|---|---|
| Diverticular disease | All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection.
Inclusion criteria: 1) imaging-proven colonic diverticular disease 2) patient aged > 18 years old; 3) Written informed consent obtained. 4) A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible Receives: Other: quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gastrointestinal Quality of Life Index (GIQLI)
The primary aim is the assessment of the quality of life of these patients according to the GIQLI score at 1 year from the enrollment in the study.
The GIQLI5 is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Why it stopped: poor recruitment status
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 Colonic 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
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Ferrari, MD, Principal investigator, ASST GOM Niguarda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907383
- Sponsor's protocol ID
- 233-22042021
- Acronym
- DDR
- Status last verified
- Mar 2024
- First submitted
- 25 May 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sassun R, Vignati B, Montroni I, Hawkins AT, Magistro C, Crippa J, Ferrari GC, Achilli P, Cocozza E, Costanzi A, Bertoglio CL, Roufael F, Maggioni D, Foppa C, Borroni G, Spinelli A, Mari G; AIMS Academy Clinical Research Network. Surgical and clinical predictors of successful Hartmann reversal procedure after perforated diverticulitis. Surg Endosc. 2026 Jun 8. doi: 10.1007/s00464-026-12937-9. Online ahead of print.
PubMed 42260170Origi M, Achilli P, Calini G, Costanzi A, Monteleone M, Montroni I, Maggioni D, Cocozza E, Megna S, Totis M, Tamini N, Ziccarelli A, Filippone G, Ferrari G, Crippa J, Spinelli A, Mari GM; AIMS Academy Clinical Research Network. The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study. Int J Surg Protoc. 2021 Aug 30;25(1):194-200. doi: 10.29337/ijsp.157. eCollection 2021.
PubMed 34541429
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Quality of Life in Patients With Acute Colonic Diverticular Disease: Diverticular Disease Registry DDR Trial
- ClinicalTrials.gov ID
- NCT04907383
- Acronym / sponsor ID
- DDR / 233-22042021
- Conditions
- Colonic Diverticulitis
- Keywords
- Diverticular disease, Acute diverticulitis, Emergency surgery, Prospective observational study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor recruitment status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 May 2021 (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.
A multicenter prospective observational study. Aim of the study is to identify the clinical parameters correlating with favorable outcomes in patients undergoing surgery or medical treatment for diverticular disease. The primary aim is be the assessment of quality of life of theses patients according to the GIQLY score at 1 year from the enrollment in the registry. Patients will be enrolled in a prospective study and followed for 36 months after the diagnosis of acute diverticulitis. All participating centres are tertiary hospitals located in Europe .
Detailed description
All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection.
Inclusion criteria: 1) imaging-proven colonic diverticular disease 2) patient aged > 18 years old; 3) Written informed consent obtained. 4) A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible Demographic and functional data will be recorded during the first surgical visit, together with a complete clinical examination. Data regarding the symptoms of presentation and quality of life will be collected and categorized. Comorbidity Index adjusted for age will be calculated for every patient, while those >70 years old will be assessed for frailty risk using the modified Frailty Index (mFI) described by Robinson et al. Relevant medications will be listed.
Setting, (emergency room vs outpatients clinic), need for admission, treatment, emergency surgery vs delayed elective surgery vs only medical management (including percutaneous drain placement) will be recorded.
Intraoperative parameters will be recorded in the registry both for emergency procedures and elective procedures, including several technical aspects such as level of inferior mesenteric artery ligtion, type of energy device used, number and type of stapler cartridge, size of circular stapler,. Use of the laparoscopy technique, conversion rate, peritoneal lavage, surgical second look will be recorded.
Histopathological examination will be recorded in terms of length of the specimen, the presence of microscopic or macroscopic abscesses, the presence of Crohn's like reaction or of lymphocyte infiltration and the eventual presence of unknown cancer.
Post-operative complications will be reported according to the Clavien-Dindo classification 15. Length of stay and post-discharge complications will be evaluated and recorded. Application of Enhanced recovery protocols will be considered only for at least 80% of the designed colo-rectal items will be satisfied.
One investigator in each center will be responsible for the follow up data. Functional follow up will be done yearly according to the GIQLY, FSFI, IIEF, ICIQ, IPSS questionnaires.
Data will be prospectively collected using a REDCAP database by the site principal investigator for each hospital. Quarterly meetings will be set between the study coordinators and the participating centers. A data manager (GP) will regularly control the quality of the data provided
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diverticular disease | – | Other: quality of lifeAll consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection. Inclusion criteria: 1) imaging-proven colonic diverticular disease 2) patient aged > 18 years old; 3) Written informed consent obtained. 4) A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic diverticulitis will be enrolled in the registry. Patients will be identified through their medical record numbers. One investigator in each center will obtain written informed consent from each patient and keep the patients updated on data collection. All patients diagnosed with left-side colonic diverticulitis who are treated in one of the participating hospitals will be asked to participate in this cohort study. The sample size will be that obtained at the end of the 5 years of recruitment. From January 2010 to December 2019, a mean number of 26 patients per year have been operated on for diverticular disease among each of the centers involved in the study. Thus, giving a total recruiting capacity of 78 patients per year, nearly 400 patients are expected to be enrolled in a 5 years' time period.
Key inclusion criteria (5 listed)
- imaging-proven colonic diverticular disease
- patient aged > 18 years old
- Written informed consent obtained
- A colonoscopy showing diverticular disease will be required during the follow-up or before surgical treatment if possible
- Patients undergoing surgical or medical treatment will be enrolled in the registry and undergo a 36-months follow up period.
Key exclusion criteria (1 listed)
- < 18 yo
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 |
|---|---|---|
| quality of lifeQoL assessment | Other | Diverticular disease |
Primary outcome
The Gastrointestinal Quality of Life Index (GIQLI)
Time frame: 1 year
The primary aim is the assessment of the quality of life of these patients according to the GIQLI score at 1 year from the enrollment in the study. The GIQLI5 is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Results and safety
The study was stopped early (reason given: poor recruitment status). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 42260170Sassun R, Vignati B, Montroni I, Hawkins AT, Magistro C, Crippa J, Ferrari GC, Achilli P, Cocozza E, Costanzi A, Bertoglio CL, Roufael F, Maggioni D, Foppa C, Borroni G, Spinelli A, Mari G; AIMS Academy Clinical Research Network. Surgical and clinical predictors of successful Hartmann reversal procedure after perforated diverticulitis. Surg Endosc. 2026 Jun 8. doi: 10.1007/s00464-026-12937-9. Online ahead of print.
- Derived from this study: PubMed 34541429Origi M, Achilli P, Calini G, Costanzi A, Monteleone M, Montroni I, Maggioni D, Cocozza E, Megna S, Totis M, Tamini N, Ziccarelli A, Filippone G, Ferrari G, Crippa J, Spinelli A, Mari GM; AIMS Academy Clinical Research Network. The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study. Int J Surg Protoc. 2021 Aug 30;25(1):194-200. doi: 10.29337/ijsp.157. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Giovanni Ferrari, MD principal investigator
ASST GOM Niguarda
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 Colonic Diverticulitis, run by Niguarda Hospital 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Mar 2024. 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 was stopped early (reason given: poor recruitment status). 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?
The Gastrointestinal Quality of Life Index (GIQLI) (time frame: 1 year). 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 NCT04907383, 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 21 Mar 2024.