Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517264
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Clinical Trial on the Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics Compared to Treatment With Antibiotics ADIANA TRIAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADIANA
Brief Summary:
The objective of this clinical trial to evaluate the effectiveness and safety of outpatient treatment without antibiotics compared to outpatient treatment with antibiotics in patients with acute uncomplicated diverticulitis
The hypotheses are
Null Hypothesis H0 Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is neither safe nor effective and is inferior to outpatient management with antibiotics
Alternative Hypothesis H1 Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is safe effective and not inferior to outpatient management with antibiotics
We compare the rate of complications therapeutic failure clinical worsening and readmission and recurrence between patients who on an outpatient basis are administered antibiotics and those who are not
The patient diagnosed with acute uncomplicated diverticulitis who meets the inclusion criteria is evaluated and examined by a general surgeon After informing himher about the pathology the study will be explained and heshe will be invited to freely participate in it After accepting and signing the informed consent form the patient will be included in the study and will be randomly assigned to one of the two treatment arms outpatient treatment with antibiotics group A or without antibiotics group B
The hypotheses are
Null Hypothesis H0 Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is neither safe nor effective and is inferior to outpatient management with antibiotics
Alternative Hypothesis H1 Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is safe effective and not inferior to outpatient management with antibiotics
We compare the rate of complications therapeutic failure clinical worsening and readmission and recurrence between patients who on an outpatient basis are administered antibiotics and those who are not
The patient diagnosed with acute uncomplicated diverticulitis who meets the inclusion criteria is evaluated and examined by a general surgeon After informing himher about the pathology the study will be explained and heshe will be invited to freely participate in it After accepting and signing the informed consent form the patient will be included in the study and will be randomly assigned to one of the two treatment arms outpatient treatment with antibiotics group A or without antibiotics group B
Detailed Description:
The surgeon must reassess the patient at 72 hours with a complete history of the new clinical status physical examination and blood tests with the same parameters This visit will check treatment adherence and early clinical response If the patient shows unfavorable progress or clear clinical deterioration a new imaging test will be considered and the assigned therapeutic option will be considered a failure Follow-up will be completed with a face-to-face consultation one month after the episode and another face-to-face or telematic at six months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None