SurgeryNCT01513421
Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection
An observational study of Surgery and Pancreatitis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill patients, this procedure allows to avoid or postpone surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Pancreatitis, Diverticulitis
- What is being tested?
- Percutaneous drainage of intra-abdominal collection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Jan 2014
- 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: In-hospital patients with infected intra-abdominal collection (primary or secondary to surgery)
Who may be able to join
- Infected intra-abdominal collection requiring a percutaneous drainage after surgery or due to a primary intra-abdominal infectious disease (e.g. diverticulitis, appendicitis)
- age over 18 years old
- intra-abdominal collections >5 cm in diameter with signs of infections on imaging
Who cannot join
- pregnancy
- age< 18 years
- signs of peritonitis
- Intensive care unit patients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Visceral surgery, CHUV
Lausanne, Canton of Vaud, 1011
Nicolas Demartines, M.D:, +41 21 314 24 00, nicolas.demartines@chuv.ch
Emmanuel Melloul, M.D., +41 21 314 24 00, emmanuel.melloul@chuv.ch
About this study
Official title: Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection: a Randomized Prospective Trial
The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill patients, this procedure allows to avoid or postpone surgery. In these settings, the percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no prospective trials has assessed the efficiency of these two modalities of drainage in cases of infected intra-abdominal collections. The investigators aimed then to prospectively analyzed the efficiency (in term of infectious control) of drainage under active vacuum pressure vs. free drainage for the treatment of infected intra-abdominal collections.
- Conditions
- Surgery, Pancreatitis, Diverticulitis, Appendicitis
- Being tested
- Percutaneous drainage of intra-abdominal collection
- Keywords
- Infected, Intra-abdominal, Collection, Drainage, Percutaneous
- Medical subject headings
- Pancreatitis, Diverticulitis, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous drainage of intra-abdominal collectionProcedure or surgery
Also called Intra-abdominal drainage, Postoperative collection
Percutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance.
Procedures perform by a board certified interventional radiologist
| Study group | Role | What they receive |
|---|---|---|
| Active vacuum pressure drainage | Not described Receives: Procedure: Percutaneous drainage of intra-abdominal collection | |
| Free drainage | Not described Receives: Procedure: Percutaneous drainage of intra-abdominal collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of drainage
Measured: 90 days after drianage
Secondary outcomes (5)
Control of infection
Measured: up to 7 days after drainage
Timing of antibiotherapy
Measured: up to 15 days after drainage
Hospital stay
Measured: up to 90 days after drainage
Morbidity related to the procedure
Measured: up to 90 days after drainage
in-hospital mortality
Measured: up to 90 days after the drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois
- Investigators
- Emmanuel Melloul, M.D., Principal investigator, Department of Visceral surgery (CHUV)Nicolas Demartines, M.D., Study chair, Department of Visceral surgery (CHUV)Alban Denys, M.D., Study chair, Department of Interventional radiology (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513421
- Sponsor's protocol ID
- 281/10
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection: a Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT01513421
- Acronym / sponsor ID
- 281/10
- Conditions
- Surgery, Pancreatitis, Diverticulitis, Appendicitis
- Keywords
- Infected, Intra-abdominal, Collection, Drainage, Percutaneous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 20 Jan 2012 (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 Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill patients, this procedure allows to avoid or postpone surgery. In these settings, the percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no prospective trials has assessed the efficiency of these two modalities of drainage in cases of infected intra-abdominal collections. The investigators aimed then to prospectively analyzed the efficiency (in term of infectious control) of drainage under active vacuum pressure vs. free drainage for the treatment of infected intra-abdominal collections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active vacuum pressure drainage | – | Procedure: Percutaneous drainage of intra-abdominal collection |
| Free drainage | – | Procedure: Percutaneous drainage of intra-abdominal collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-hospital patients with infected intra-abdominal collection (primary or secondary to surgery)
Key inclusion criteria (3 listed)
- Infected intra-abdominal collection requiring a percutaneous drainage after surgery or due to a primary intra-abdominal infectious disease (e.g. diverticulitis, appendicitis)
- age over 18 years old
- intra-abdominal collections >5 cm in diameter with signs of infections on imaging
Key exclusion criteria (4 listed)
- pregnancy
- age< 18 years
- signs of peritonitis
- Intensive care unit patients
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 |
|---|---|---|
| Percutaneous drainage of intra-abdominal collectionAlso: Intra-abdominal drainage, Postoperative collectionPercutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance. Procedures perform by a board certified interventional radiologist | Procedure or surgery | Active vacuum pressure drainage, Free drainage |
Primary outcome
time of drainage
Time frame: 90 days after drianage
5 secondary outcomes
Control of infection
Time frame: up to 7 days after drainage
Timing of antibiotherapy
Time frame: up to 15 days after drainage
Hospital stay
Time frame: up to 90 days after drainage
Morbidity related to the procedure
Time frame: up to 90 days after drainage
in-hospital mortality
Time frame: up to 90 days after the drainage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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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.
Emmanuel Melloul, M.D. principal investigator
Department of Visceral surgery (CHUV)
Nicolas Demartines, M.D. study chair
Department of Visceral surgery (CHUV)
Alban Denys, M.D. study chair
Department of Interventional radiology (CHUV)
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 Surgery and Pancreatitis, run by Centre Hospitalier Universitaire Vaudois 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 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Demartines, M.D. (+41 21 314 24 00, nicolas.demartines@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of drainage (time frame: 90 days after drianage). 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 23 Jan 2012.