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The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Primary Purpose

Perforated Appendicitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appendectomy
Observation
Sponsored by
Marshall University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Appendicitis focused on measuring Perforated appendicitis, Pediatric appendicitis, Appendectomy, Appendiceal abscess, Antibiotic Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women of all ages.
  • Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
  • Formal consent for the present study must be signed by the patient or his/her parents
  • Patients with initial presentation of a phlegmon (abscess in evolution)

Exclusion Criteria:

  • Patients with non-perforated appendicitis
  • Presentation with initially non-perforated appendicitis but found perforation at surgery
  • Patient with septic shock
  • Patients who had previous appendectomy
  • Current treatment of malignancy
  • Immunocompromised patients
  • Positive pregnancy test
  • No consent for the study

Sites / Locations

  • Marshall University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Standard pediatric group:

Experimental pediatric group:

Standard adult group:

Experimental adult group:

Arm Description

patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)

patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)

patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)

Patients ≥18 yo with acute perforated appendicitis and observation (n=25)

Outcomes

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 rate of complete response after percutaneous drainage and antibiotic therapy
Determine the mean surgical value (quality/cost) for each group

Full Information

First Posted
January 29, 2020
Last Updated
April 3, 2023
Sponsor
Marshall University
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1. Study Identification

Unique Protocol Identification Number
NCT04253899
Brief Title
The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations
Official Title
The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshall University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment. A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Appendicitis
Keywords
Perforated appendicitis, Pediatric appendicitis, Appendectomy, Appendiceal abscess, Antibiotic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard pediatric group:
Arm Type
Active Comparator
Arm Description
patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Arm Title
Experimental pediatric group:
Arm Type
Experimental
Arm Description
patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Arm Title
Standard adult group:
Arm Type
Active Comparator
Arm Description
patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
Arm Title
Experimental adult group:
Arm Type
Experimental
Arm Description
Patients ≥18 yo with acute perforated appendicitis and observation (n=25)
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Intervention Description
Interval Appendectomy
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
observation and follow up
Primary Outcome Measure Information:
Title
Determine rate and severity of complications after interval appendectomy
Time Frame
12 months
Title
Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Determine the rate of complete response after percutaneous drainage and antibiotic therapy
Time Frame
12 months
Title
Determine the mean surgical value (quality/cost) for each group
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women of all ages. Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis. Formal consent for the present study must be signed by the patient or his/her parents Patients with initial presentation of a phlegmon (abscess in evolution) Exclusion Criteria: Patients with non-perforated appendicitis Presentation with initially non-perforated appendicitis but found perforation at surgery Patient with septic shock Patients who had previous appendectomy Current treatment of malignancy Immunocompromised patients Positive pregnancy test No consent for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Sanabria, MD MSc FACS
Phone
216 647 8399
Email
sanabriaj@marshall.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Abdelmasseh, MD
Email
abdelmasseh@marshall.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Sanabria, MD MSc FACS
Organizational Affiliation
Marshall University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marshall University School of Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Sanabria, MD MSc FACS
Phone
216-647-8399
Email
sanabriaj@marshall.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

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