Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838248
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-04-03
Brief Title:
Complex and Simple Appendicitis REstrictive or Liberal Post-operative Antibiotic eXposure CASA RELAX
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Complex and Simple Appendicitis REstrictive or Liberal Post-operative Antibiotic eXposure CASA RELAX Using Desirability of Outcome Ranking DOOR and Response Adjusted for Duration of Antibiotic Risk RADAR
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASA-RELAX
Brief Summary:
This prospective trial will randomize patients who have had an appendectomy to two different durations of antibiotic therapy depending on the status of the appendicitis For simple appendicitis patients will be randomized to peri-operative antibiotics or 24 hours duration For complex appendicitis patients will be randomized to 24 hours or 4 days duration Data will be collected prospectively and test the hypothesis that shorter durations of antibiotics will be non-inferior to the longer durations
Detailed Description:
All patients will be recruited into the study and these patients will be randomized in permuted blocks of 4 to 6 to one of two arms Each arm will have two treatments which will be given to the patient depending on the case nature acute or complicated Comparisons in DOOR outcome will be compared only within the case nature strata by treatment since the stratification criteria makes comparisons between strata not feasible In order to attempt to retrieve the expected rates of DOOR outcomes from a Randomized Controlled Trial RCT propensity score matching via the MatchIt algorithm was utilized The issue being mitigated is that our patients were part of an observation where treatment was a byproduct of patient characteristics which would introduce selection into treatment bias and our direct estimates of DOOR outcomes would not be valid for powering an RCT AAST clinical grade body mass index age Charlson Comorbidity Index CCI and prior operations were used in the matching 11 matching was utilized resulting in 479 match pairs from the MUSTANG dataset and diagnostics for matches were explored and it suggested that good matches were obtained Below are the rates from the matched set one observation was added to every cell to ensure that there were no zero probabilities in the assumptions The investigators will recruit patients until a sufficient number of complicated cases to be sufficiently powered for our comparison on treatment within the complicated strata Since the investigators expect fewer than 50 to be complicated cases a larger sample size should be available for analysis in the acute simple arm Thus the clinical trial will be powered for an even larger effect size for simple appendicitis and if a statistically significant difference is not found it is very likely that if there is a difference it would not be clinically meaningful Also since each analysis will depend on a mutually exclusive set of patients the investigators can consider these to be independent samples for which no adjustment for multiple testing is required Difference in DOOR score will be tested restrictive versus liberal strategies via proportional odds regression accounting for enrollment site and age strata The primary endpoint will be analyzed using an intention-to treat analysis In case a significant difference is discovered the investigators plan to calculate the Fragility Index to determine the fragility of the study results Significance will be determined at an alpha of 005 All analyses will be performed in R version 361 using the clusrank package Potential subjects will be identified by the clinical team Acute Care Surgery during the course of usual clinical care and the clinical team will inform the subjects about the study and seek their verbal approval to being approached by the study research team The patient will then be approached by the research team in the emergency department pre-operative holding area or hospital ward for detailed discussion about the study and for informed consent as outlined in the consent procedures below If the subject consents to participate and agrees to be randomized randomization will take place and the subject will be assigned to one of the two study groups restricted or liberal If the subject consents to participate but declines to be randomized we will seek to enroll the patient in an observational arm the clinician will decide the duration of post-operative antibiotic therapy and data will be collected from the subjects medical records and through a telephone call at approximately 1 month after hospital discharge It is not possible to obtain consent to participate in this study on another day because if the patient has simple acute appendicitis 80 of cases they are usually discharged home immediately after surgery or within 12 hours of surgery For complicated appendicitis patients 20 the restrictive arm is randomized to only 1 day of post-operative antibiotics and obtaining consent the following day would be too late to assign the subject to this arm Recruitment will not involve restrictions on socio-demographic factors including gender or ethnic characteristics Recruitment will be devoid of any procedures which could be constructed as coercive Study researchers and clinicians will stress that participation is voluntary that patients are not obliged to participate and that the decision not to participate in the study will not affect patient care All subjects will be contacted by telephone at approximately 1 month or later after the index operation and will be assigned to 7 mutually exclusive hierarchical ie ordinal categories in decreasing order of desirability
1 Cure no adverse effects
2 Infectiousantibiotic complication requiring antibiotic treatment only only or no specific treatment
3 Infectiousantibiotic complication requiring Emergency Department visit
4 Infectiousantibiotic complication requiring hospital readmission
5 Infectiousantibiotic complication requiring percutaneous drainage
6 Infectiousantibiotic complication requiring operative intervention
7 Death Study subjects will be assigned unique study numbers that will be used in all study documents No actual names will be used in the study Only the researchers will know the actual names of the subjects Study database and documents will be stored in a locked research office at William G Cheadles office in the ambulatory care building within the Department of Surgery with key access only and will only be accessible to the researchers A copy of the de-identified data will be stored on REDCap
1 Cure no adverse effects
2 Infectiousantibiotic complication requiring antibiotic treatment only only or no specific treatment
3 Infectiousantibiotic complication requiring Emergency Department visit
4 Infectiousantibiotic complication requiring hospital readmission
5 Infectiousantibiotic complication requiring percutaneous drainage
6 Infectiousantibiotic complication requiring operative intervention
7 Death Study subjects will be assigned unique study numbers that will be used in all study documents No actual names will be used in the study Only the researchers will know the actual names of the subjects Study database and documents will be stored in a locked research office at William G Cheadles office in the ambulatory care building within the Department of Surgery with key access only and will only be accessible to the researchers A copy of the de-identified data will be stored on REDCap
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None