Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
NCT ID: NCT03008707
Last Updated: 2019-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
66 participants
OBSERVATIONAL
2015-11-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
Patients who undergo Laparoscopic Peritoneal Lavage
Laparoscopic Peritoneal Lavage
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
Group 2
Patients who have a laparoscopically approached sigmoidectomy
No interventions assigned to this group
Interventions
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Laparoscopic Peritoneal Lavage
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
Eligibility Criteria
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Inclusion Criteria
* Signs of localized or diffuse peritonitis
* Signs of suspected perforated diverticulitis (diagnostic imaging)
* Signed informed consent
Exclusion Criteria
* Immunodepression
* Previous multiple abdominal surgical operations
* Modified Hinchey's grade IV
18 Years
ALL
No
Sponsors
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Ospedale San Jacopo, Pistoia
UNKNOWN
S. Andrea Hospital
OTHER
Maggiore Bellaria Hospital, Bologna
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
A.O. Ospedale Papa Giovanni XXIII
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
George Papanicolaou Hospital
OTHER
Azienda Ospedaliero, Universitaria Pisana
OTHER
Responsible Party
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Dario Tartaglia
MD, PhD Candidate
Principal Investigators
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Dario Tartaglia, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero, Universitaria Pisana
Locations
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Azienda Ospedaliero, Universitaria Pisana
Pisa, Tuscany, Italy
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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n° 890
Identifier Type: -
Identifier Source: org_study_id
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