Acute DiverticulitisSTELLANCT03008707
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
An observational study of Acute Diverticulitis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Laparoscopic Peritoneal Lavage
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with complicated acute diverticulitis
Who may be able to join
- Acute abdominal pain,
- Signs of localized or diffuse peritonitis
- Signs of suspected perforated diverticulitis (diagnostic imaging)
- Signed informed consent
Who cannot join
- Septic shock
- Immunodepression
- Previous multiple abdominal surgical operations
- Modified Hinchey's grade IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study
Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD
Read the detailed description
In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. Recently, three important prospective randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions, as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in the short-term. To our knowledge, no international guidelines promote the use of LPL in complicated acute diverticulitis. We believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. The aim of the study is to collect and analyze the multicentric data of the LPL and LS and give a substantial contribution to the scientific community about this very debated topic.
- Conditions
- Acute Diverticulitis
- Being tested
- Laparoscopic Peritoneal Lavage
- Keywords
- Laparoscopic peritoneal lavage, laparoscopic sigmoidectomy, complicated acute diverticulitis, D004238
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Peritoneal LavageProcedure or surgery
LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who undergo Laparoscopic Peritoneal Lavage Receives: Procedure: Laparoscopic Peritoneal Lavage | |
| Group 2 | Patients who have a laparoscopically approached sigmoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Morbidity
Measured: 30 days
Short-term Mortality
Measured: 30 days
Optimal Sepsis Control
Measured: 30 days
Post-operative Re-interventions Rate
Measured: 15 days
Secondary outcomes (4)
Mean Postoperative Time
Measured: 1 day
Average Length of Postoperative Hospital Stay
Measured: 30 day
Recurrent Colonic Diverticulitis Rate
Measured: 6 months
Incisional Hernia Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startNov 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Jacopo, Pistoia, S. Andrea Hospital, Maggiore Bellaria Hospital, Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, A.O. Ospedale Papa Giovanni XXIII, Hospitales Universitarios Virgen del Rocío, George Papanicolaou Hospital
- Responsible party
- Principal investigator, Dario Tartaglia, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Dario Tartaglia, MD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008707
- Sponsor's protocol ID
- n° 890
- Acronym
- STELLA
- Status last verified
- Aug 2019
- First submitted
- 29 Dec 2016
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03008707
- Acronym / sponsor ID
- STELLA / n° 890
- Conditions
- Acute Diverticulitis
- Keywords
- Laparoscopic peritoneal lavage, laparoscopic sigmoidectomy, complicated acute diverticulitis, D004238
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- Ospedale San Jacopo, Pistoia, S. Andrea Hospital, Maggiore Bellaria Hospital, Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, A.O. Ospedale Papa Giovanni XXIII, Hospitales Universitarios Virgen del Rocío, George Papanicolaou Hospital
- Study start
- Nov 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD
Detailed description
In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. Recently, three important prospective randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions, as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in the short-term. To our knowledge, no international guidelines promote the use of LPL in complicated acute diverticulitis. We believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. The aim of the study is to collect and analyze the multicentric data of the LPL and LS and give a substantial contribution to the scientific community about this very debated topic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Laparoscopic Peritoneal LavagePatients who undergo Laparoscopic Peritoneal Lavage |
| Group 2 | – | –Patients who have a laparoscopically approached sigmoidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complicated acute diverticulitis
Key inclusion criteria (4 listed)
- Acute abdominal pain,
- Signs of localized or diffuse peritonitis
- Signs of suspected perforated diverticulitis (diagnostic imaging)
- Signed informed consent
Key exclusion criteria (4 listed)
- Septic shock
- Immunodepression
- Previous multiple abdominal surgical operations
- Modified Hinchey's grade IV
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 |
|---|---|---|
| Laparoscopic Peritoneal LavageLPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites | Procedure or surgery | Group 1 |
Primary outcome
Short-term Morbidity
Time frame: 30 days
Short-term Mortality
Time frame: 30 days
Optimal Sepsis Control
Time frame: 30 days
Post-operative Re-interventions Rate
Time frame: 15 days
4 secondary outcomes
Mean Postoperative Time
Time frame: 1 day
Average Length of Postoperative Hospital Stay
Time frame: 30 day
Recurrent Colonic Diverticulitis Rate
Time frame: 6 months
Incisional Hernia Rate
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Diverticulitis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
RecruitingObservational study
Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
Intra Abdominal Infections, Appendicitis Acute
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.
Dario Tartaglia, MD principal investigator
Azienda Ospedaliero, Universitaria Pisana
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 Acute Diverticulitis, run by Azienda Ospedaliero, Universitaria Pisana 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 4 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 25 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Short-term Morbidity (time frame: 30 days). The study lists 4 primary outcomes in all. 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 25 Sep 2019.