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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 12 months
Awards & highlights

Study 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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine rate and severity of complications after interval appendectomy
Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
Secondary outcome measures
Determine the mean surgical value (quality/cost) for each group
Determine the rate of complete response after percutaneous drainage and antibiotic therapy

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997
31%
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%
Mood alteration-depression
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)

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

Appendectomy (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04253899 — N/A
Appendicitis Research Study Groups: Standard pediatric group:, Experimental pediatric group:, Standard adult group:, Experimental adult group:
Appendicitis Clinical Trial 2023: Appendectomy Highlights & Side Effects. Trial Name: NCT04253899 — N/A
Appendectomy (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04253899 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations
Juan Sanabria 2020. "The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04253899.
All > Appendicitis
~20 spots leftby Apr 2025
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