NCT04253899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

3.7 years

First QC Date

January 29, 2020

Last Update Submit

April 3, 2023

Conditions

Perforated Appendicitis

Keywords

Perforated appendicitisPediatric appendicitisAppendectomyAppendiceal abscessAntibiotic Therapy

Outcome Measures

Primary Outcomes (2)

  • Determine rate and severity of complications after interval appendectomy

    12 months

  • Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis

    12 months

Secondary Outcomes (2)

  • Determine the rate of complete response after percutaneous drainage and antibiotic therapy

    12 months

  • Determine the mean surgical value (quality/cost) for each group

    12 months

Study Arms (4)

Standard pediatric group:

ACTIVE COMPARATOR

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

Procedure: Appendectomy

Experimental pediatric group:

EXPERIMENTAL

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

Other: Observation

Standard adult group:

ACTIVE COMPARATOR

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

Procedure: Appendectomy

Experimental adult group:

EXPERIMENTAL

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

Other: Observation

Interventions

AppendectomyPROCEDURE

Interval Appendectomy

Standard adult group:Standard pediatric group:
ObservationOTHER

observation and follow up

Experimental adult group:Experimental pediatric group:

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marshall University School of Medicine

Huntington, West Virginia, 25701, United States

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

AppendectomyObservation

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeMethodsInvestigative Techniques

Study Officials

  • Juan Sanabria, MD MSc FACS

    Marshall University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Sanabria, MD MSc FACS

CONTACT

216 647 8399sanabriaj@marshall.edu

Michael Abdelmasseh, MD

CONTACT

abdelmasseh@marshall.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

February 20, 2020

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)