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Surgery
Observation for Appendicitis
N/A
Recruiting
Led By Juan Sanabria, MD MSc FACS
Research Sponsored by Marshall University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for appendicitis that may be less invasive than surgery. Patients with appendicitis will be treated with antibiotics and, if they improve, will be discharged and monitored. If they do not improve, they will stay in the hospital for more treatment.
Eligible Conditions
- Appendicitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2016 Phase 3 trial • 356 Patients • NCT0004899731%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Mood alteration-depression
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Experimental pediatric group:Experimental Treatment1 Intervention
patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Group II: Experimental adult group:Experimental Treatment1 Intervention
Patients ≥18 yo with acute perforated appendicitis and observation (n=25)
Group III: Standard pediatric group:Active Control1 Intervention
patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Group IV: Standard adult group:Active Control1 Intervention
patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
Find a Location
Who is running the clinical trial?
Marshall UniversityLead Sponsor
20 Previous Clinical Trials
4,062 Total Patients Enrolled
Juan Sanabria, MD MSc FACS5.01 ReviewsPrincipal Investigator - Marshall University School of Medicine
Marshall University
1 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have appendicitis that has not caused your appendix to burst.You have septic shock.You have had your appendix removed in the past.You have a weakened immune system.People of any age and gender can participate.You have an abscess that is still developing.
Research Study Groups:
This trial has the following groups:- Group 1: Standard pediatric group:
- Group 2: Experimental pediatric group:
- Group 3: Standard adult group:
- Group 4: Experimental adult group:
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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