Lung Transplant RecipientsNCT02132078
Epidemiology of Diverticulitis in Lung Transplant Recipients
An observational study of Lung Transplant Recipients and Diverticulitis, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess incidence, treatment modalities and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) in order to establish improved treatment strategies in this high risk patient collective. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Transplant Recipients, Diverticulitis
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1992to Dec 2013
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We want to retrospectively analyse our prospective database of lung transplant recipients at our institution between 1992 and 2013 with diverticulitis episodes.
Who may be able to join
- Lung transplant recipient
- Diverticulitis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral- and Transplant Surgery, University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Long-term Follow-up of Lung Transplant Recipients With Diverticulitis
The purpose of this study is to assess incidence, treatment modalities and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) in order to establish improved treatment strategies in this high risk patient collective.
Read the detailed description
Sigmoid diverticulitis is common and potentially problematic in immunosuppressed patients. The choice between conservative and surgical treatment for uncomplicated diverticulitis remains unclear, as well as the value of the Hartmann's procedure (HP) for complicated diverticulitis.
Our aim is to assess incidence, treatment options and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) by retrospectively analysing our prospective database of around 400 lung transplant recipients transplanted between 1992 and 2013.
- Conditions
- Lung Transplant Recipients, Diverticulitis
- Keywords
- Lung transplant recipients, diverticulitis, immunosuppression
- Medical subject headings
- Diverticulitis
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 |
|---|---|---|
| Lung transplant recipients with uncomplicated diverticulitis | Retrospective data analysis of treatment, outcome and recurrency-rate | |
| Lung transplant recipients with complicated diverticulitis | Retrospective data analysis of treatment, outcome and recurrency-rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of Diverticulitis in Lung Transplant Recipients
Our aim is to assess incidence, treatment options and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) by retrospectively analysing a prospective database of around 400 LTRs transplanted between 1992 and 2013.
Measured: January 1992- December 2013 (22 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 1992
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nocito Antonio, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132078
- Sponsor's protocol ID
- LTR_Diverticulitis
- Status last verified
- May 2014
- First submitted
- 4 May 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Lung Transplant Recipients With Diverticulitis
- ClinicalTrials.gov ID
- NCT02132078
- Acronym / sponsor ID
- LTR_Diverticulitis
- Conditions
- Lung Transplant Recipients, Diverticulitis
- Keywords
- Lung transplant recipients, diverticulitis, immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 1992
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 May 2014 (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.
The purpose of this study is to assess incidence, treatment modalities and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) in order to establish improved treatment strategies in this high risk patient collective.
Detailed description
Sigmoid diverticulitis is common and potentially problematic in immunosuppressed patients. The choice between conservative and surgical treatment for uncomplicated diverticulitis remains unclear, as well as the value of the Hartmann's procedure (HP) for complicated diverticulitis.
Our aim is to assess incidence, treatment options and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) by retrospectively analysing our prospective database of around 400 lung transplant recipients transplanted between 1992 and 2013.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung transplant recipients with uncomplicated diverticulitis | – | –Retrospective data analysis of treatment, outcome and recurrency-rate |
| Lung transplant recipients with complicated diverticulitis | – | –Retrospective data analysis of treatment, outcome and recurrency-rate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We want to retrospectively analyse our prospective database of lung transplant recipients at our institution between 1992 and 2013 with diverticulitis episodes.
Key inclusion criteria (2 listed)
- Lung transplant recipient
- Diverticulitis
Key exclusion criteria (1 listed)
- none
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
Epidemiology of Diverticulitis in Lung Transplant Recipients
Time frame: January 1992- December 2013 (22 years)
Our aim is to assess incidence, treatment options and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) by retrospectively analysing a prospective database of around 400 LTRs transplanted between 1992 and 2013.
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 6 May 2014.
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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 Lung Transplant Recipients and Diverticulitis, run by University of Zurich 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?
The sponsor lists 2 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: finished, as of the sponsor's last update on 6 May 2014. 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?
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?
Epidemiology of Diverticulitis in Lung Transplant Recipients (time frame: January 1992- December 2013 (22 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 6 May 2014.