Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
STELLA
1 other identifier
observational
66
1 country
1
Brief 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). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
September 25, 2019
CompletedSeptember 25, 2019
August 1, 2019
3.2 years
December 29, 2016
June 7, 2019
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Short-term Morbidity
30 days
Short-term Mortality
30 days
Optimal Sepsis Control
30 days
Post-operative Re-interventions Rate
15 days
Secondary Outcomes (4)
Mean Postoperative Time
1 day
Average Length of Postoperative Hospital Stay
30 day
Recurrent Colonic Diverticulitis Rate
6 months
Incisional Hernia Rate
6 months
Study Arms (2)
Group 1
Patients who undergo Laparoscopic Peritoneal Lavage
Group 2
Patients who have a laparoscopically approached sigmoidectomy
Interventions
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
Patients with complicated acute diverticulitis
You may qualify if:
- Acute abdominal pain,
- Signs of localized or diffuse peritonitis
- Signs of suspected perforated diverticulitis (diagnostic imaging)
- Signed informed consent
You may not qualify if:
- Septic shock
- Immunodepression
- Previous multiple abdominal surgical operations
- Modified Hinchey's grade IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Ospedaliero, Universitaria Pisanalead
- Ospedale San Jacopo, Pistoiacollaborator
- S. Andrea Hospitalcollaborator
- Maggiore Bellaria Hospital, Bolognacollaborator
- IRCCS Azienda Ospedaliero-Universitaria di Bolognacollaborator
- A.O. Ospedale Papa Giovanni XXIIIcollaborator
- Hospitales Universitarios Virgen del Rocíocollaborator
- George Papanicolaou Hospitalcollaborator
Study Sites (1)
Azienda Ospedaliero, Universitaria Pisana
Pisa, Tuscany, 56021, Italy
Results Point of Contact
- Title
- Dario Tartaglia
- Organization
- University of Pusa
Study Officials
- PRINCIPAL INVESTIGATOR
Dario Tartaglia, MD
Azienda Ospedaliero, Universitaria Pisana
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD Candidate
Study Record Dates
First Submitted
December 29, 2016
First Posted
January 2, 2017
Study Start
November 1, 2015
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
September 25, 2019
Results First Posted
September 25, 2019
Record last verified: 2019-08