Optimal Care of Complicated Appendicitis

NCT03159754 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00103791
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Three common treatments for complicated appendicitis are

• appendectomy (removal of the appendix) right away
• appendectomy several weeks after the diagnosis
• treating the appendicitis without performing an appendectomy This study seeks to determine which of these three approaches is most cost-effective in children with complicated appendicitis.

Conditions

Appendicitis; Perforated Appendicitis; Ruptured Appendicitis; Complicated Appendicitis

Outcome Measures

Primary Outcomes (1)

• Overall Cost of Care

  Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time.

  The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies.

Secondary Outcomes (8)

• Complications

  During index/initial hospitalization (generally not more than 5-6 weeks)

• Parents Away From Work

  During index/initial hospitalization (generally not more than 5-6 weeks)

• Duration of Antibiotic Therapy

  During index/initial hospitalization (generally not more than 5-6 weeks)

• Length of Stay

  During index/initial hospitalization (generally not more than 5-6 weeks)

• Number of Percutaneous Drainage Procedures

  During index/initial hospitalization (generally not more than 5-6 weeks)

Study Arms (3)

Early Appendectomy

EXPERIMENTAL

Procedure: Early Appendectomy; Drug: Antibiotics

Interval Appendectomy

EXPERIMENTAL

Procedure: Interval Appendectomy; Drug: Antibiotics

No Appendectomy

EXPERIMENTAL

Drug: Antibiotics

Interventions

Early Appendectomy PROCEDURE

Removal of the appendix within 24 hours of admission

Early Appendectomy

Interval Appendectomy PROCEDURE

Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.

Interval Appendectomy

Antibiotics DRUG

Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.

Also known as: Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole

Early Appendectomy; Interval Appendectomy; No Appendectomy

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At least 1 of the following CT or MRI findings:
• Peri-appendicular abscess
• Extruded appendicolith
• Visible hole in appendiceal wall
• Free peritoneal air
• CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3 of the following (with CT) or 2 of 3 of the following (with MRI) \*:
• White blood cell count (WBC) \>15
• Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign, percussion tenderness, and/or rebound tenderness)
• Temperature \> 38.0 C \*\>90% specificity for complicated appendicitis based on unpublished institutional data

You may not qualify if:

• Immunocompromized state
• History of major abdominal operation
• Previous appendicitis
• Major comorbidities that preclude safe operation
• Inability to follow-up or appropriately consent
• Pregnant women
• Allergy to penicillin plus any one of the following:
• Hypersensitivity to ciprofloxacin and/or metronidazole
• Pregnant/lactating women
• Patients taking theophylline
• Patient taking tizanidine

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Anti-Bacterial Agents; Piperacillin, Tazobactam Drug Combination; Piperacillin; Tazobactam; Ciprofloxacin; Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Steven Bruch, MD
• Organization: University of Michigan

sbruch@umich.edu

7349368464

Study Officials

• Steven W. Bruch, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: June 29, 2017
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Locations

US (1)