Peritonitis Caused by Perforated Left-sided Colon DiverticulitisPhase 2/3NCT01239927
Hartmann vs R/A in Peritonitis by Perforated Diverticulitis
A Phase 2/3 study testing Primary sigmoid resection with end colostomy (Hartmann) and Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA) in people with Peritonitis Caused by Perforated Left-sided Colon Diverticulitis, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
Trial summary
This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritonitis Caused by Perforated Left-sided Colon Diverticulitis
- What is being tested?
- Primary sigmoid resection with end colostomy (Hartmann) and Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2000to Jul 2010
- Phase
- Phase 2/3
- 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
Who may be able to join
- Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.
This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.
- Being tested
- Primary sigmoid resection with end colostomy (Hartmann), Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)
- Keywords
- diverticulitis, hartmann, anastomosis
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary sigmoid resection with end colostomy (Hartmann)Procedure or surgery
Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality and morbidity after emergency surgery
Measured: 30-day
Secondary outcomes (1)
30-day mortality and morbidity after elective restoration of intestinal transit
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJan 2000
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritonitis Caused by Perforated Left-sided Colon 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Bergamaschi, MD, Study chair, Division of Colon & Rectal Surgery State University of New York Stony Brook, New YorkGian Andrea Binda, Study director, EO Ospedali Galliera, Genova, ItalyAlberto Serventi, Principal investigator, EO Ospedali Galliera, Genova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239927
- Sponsor's protocol ID
- PRTHRAPDP
- Status last verified
- Jul 2010
- First submitted
- 12 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01239927
- Acronym / sponsor ID
- PRTHRAPDP
- Keywords
- diverticulitis, hartmann, anastomosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Nov 2010 (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.
This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Primary sigmoid resection with end colostomy (Hartmann) | Procedure or surgery | – |
| Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA) | Procedure or surgery | – |
Primary outcome
30-day mortality and morbidity after emergency surgery
Time frame: 30-day
1 secondary outcome
30-day mortality and morbidity after elective restoration of intestinal transit
Time frame: 30 day
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 15 Nov 2010.
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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.
Roberto Bergamaschi, MD study chair
Division of Colon & Rectal Surgery State University of New York Stony Brook, New York
Gian Andrea Binda study director
EO Ospedali Galliera, Genova, Italy
Alberto Serventi principal investigator
EO Ospedali Galliera, Genova, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Primary sigmoid resection with end colostomy (Hartmann) and Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA) in people with Peritonitis Caused by Perforated Left-sided Colon Diverticulitis, run by Ente Ospedaliero Ospedali Galliera 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 1 inclusion and 0 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 15 Nov 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
30-day mortality and morbidity after emergency surgery (time frame: 30-day). 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 15 Nov 2010.