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The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253899
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Juan Sanabria, Marshall University

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.


Condition or disease Intervention/treatment Phase
Perforated Appendicitis Procedure: Appendectomy Other: Observation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: Standard pediatric group:
patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Procedure: Appendectomy
Interval Appendectomy

Experimental: Experimental pediatric group:
patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Other: Observation
observation and follow up

Active Comparator: Standard adult group:
patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
Procedure: Appendectomy
Interval Appendectomy

Experimental: Experimental adult group:
Patients ≥18 yo with acute perforated appendicitis and observation (n=25)
Other: Observation
observation and follow up




Primary Outcome Measures :
  1. Determine rate and severity of complications after interval appendectomy [ Time Frame: 12 months ]
  2. Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Determine the rate of complete response after percutaneous drainage and antibiotic therapy [ Time Frame: 12 months ]
  2. Determine the mean surgical value (quality/cost) for each group [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253899


Contacts
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Contact: Juan Sanabria, MD MSc FACS 216 647 8399 sanabriaj@marshall.edu
Contact: Michael Abdelmasseh, MD abdelmasseh@marshall.edu

Locations
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United States, West Virginia
Marshall University School of Medicine Recruiting
Huntington, West Virginia, United States, 25701
Contact: Juan Sanabria, MD MSc FACS    216-647-8399    sanabriaj@marshall.edu   
Sponsors and Collaborators
Marshall University
Investigators
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Principal Investigator: Juan Sanabria, MD MSc FACS Marshall University School of Medicine
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Responsible Party: Juan Sanabria, Professor of Surgery, Marshall University
ClinicalTrials.gov Identifier: NCT04253899    
Other Study ID Numbers: 1504002-3
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Sanabria, Marshall University:
Perforated appendicitis
Pediatric appendicitis
Appendectomy
Appendiceal abscess
Antibiotic Therapy
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases