|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03008707 |
|
Date of registration:
|
29/12/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
STELLA |
|
Scientific title:
|
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study |
|
Date of first enrolment:
|
November 2015 |
|
Target sample size:
|
66 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03008707 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Dario Tartaglia, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Azienda Ospedaliero, Universitaria Pisana |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Acute abdominal pain,
- Signs of localized or diffuse peritonitis
- Signs of suspected perforated diverticulitis (diagnostic imaging)
- Signed informed consent
Exclusion Criteria:
- Septic shock
- Immunodepression
- Previous multiple abdominal surgical operations
- Modified Hinchey's grade IV
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Diverticulitis
|
|
Intervention(s)
|
|
Procedure: Laparoscopic Peritoneal Lavage
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
Incisional Hernia Rate
[Time Frame: 6 months]
|
|
Average Length of Postoperative Hospital Stay
[Time Frame: 30 day]
|
|
Recurrent Colonic Diverticulitis Rate
[Time Frame: 6 months]
|
|
Mean Postoperative Time
[Time Frame: 1 day]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|