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Optimal Care of Complicated Appendicitis

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ClinicalTrials.gov Identifier: NCT03159754
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Steven W. Bruch, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Appendicitis Perforated Appendicitis Ruptured Appendicitis Complicated Appendicitis Procedure: Early Appendectomy Procedure: Interval Appendectomy Drug: Antibiotics Not Applicable

Detailed Description:
This is a single center, prospective study to compare early appendectomy vs. non-operative management of immunocompetent patients with complicated appendicitis, and then to compare interval appendectomy vs. no interval appendectomy in those managed with the initial non-operative approach. Patients who choose early appendectomy will have surgery within 24 hours of diagnosis and be discharged once they are afebrile for 24 hours, have a normal WBC count, and can tolerate a diet. They will be discharged with 5 days of oral ciprofloxacin and metronidazole and follow-up in clinic 2-4 weeks later. Patients who choose non-operative management will receive piperacillin-tazobactam with or without abscess drainage until they are afebrile 24 hours with a normal WBC count and are tolerating a diet, followed by 5 days of oral ciprofloxacin and metronidazole upon discharge. These patients will then be seen in clinic in 2-4 weeks, at which time they will be given the choice of whether or not to undergo interval appendectomy at least 8 weeks from initial presentation. Those in the interval appendectomy group will follow-up one month post-operatively. Patients in both groups will be contacted 3 months and 2 years following initial presentation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Care of Complicated Appendicitis
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Early Appendectomy Procedure: Early Appendectomy
Removal of the appendix within 24 hours of admission
Drug: Antibiotics
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other Name: Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole
Experimental: Interval Appendectomy Procedure: Interval Appendectomy
Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.
Drug: Antibiotics
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other Name: Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole
Experimental: No Appendectomy Drug: Antibiotics
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other Name: Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole



Primary Outcome Measures :
  1. Overall cost of care [ Time Frame: 2 years ]
    Total health care cost starting from time of admission


Secondary Outcome Measures :
  1. Complications [ Time Frame: 2 years ]
    Number of persons who experience any of a number of specified complications, including new/recurrent abscess, wound infection, small bowel obstruction, or need for a more larger operation

  2. Time away from activity/parents away from work [ Time Frame: 2 years ]
    Time away from activity/parents away from work measured in days

  3. Duration of antibiotic therapy [ Time Frame: 2 years ]
    Duration of antibiotic therapy measured in days

  4. Length of stay [ Time Frame: 2 years ]
    Length of hospital all hospital stays measured in days

  5. Number of percutaneous drainage procedures [ Time Frame: 2 years ]
    Number of percutaneous drainage procedures

  6. Number of radiographic imaging studies [ Time Frame: 2 years ]
    Number of radiographic imaging studies including ultrasound, CT, and MRI

  7. Quality of life [ Time Frame: 2 years ]
    Quality of life measured by PedsQL 2 years following discharge

  8. Recurrent appendicitis [ Time Frame: 2 years ]
    Number of persons who experience recurrent appendicitis requiring hospitalization



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. At least 1 of the following CT or MRI findings:

    1. Peri-appendicular abscess
    2. Extruded appendicolith
    3. Visible hole in appendiceal wall
    4. Free peritoneal air

    OR

  2. 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) *:

    1. White blood cell count (WBC) >15
    2. Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign, percussion tenderness, and/or rebound tenderness)
    3. Temperature > 38.0 C *>90% specificity for complicated appendicitis based on unpublished institutional data

Exclusion Criteria

  1. Immunocompromized state
  2. History of major abdominal operation
  3. Previous appendicitis
  4. Major comorbidities that preclude safe operation
  5. Inability to follow-up or appropriately consent
  6. Pregnant women
  7. Allergy to penicillin plus any one of the following:

    1. Hypersensitivity to ciprofloxacin and/or metronidazole
    2. Pregnant/lactating women
    3. Patients taking theophylline
    4. Patient taking tizanidine

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): NCT03159754


Contacts
Contact: Sarah E. Fox, B.A. 734-232-8005 sarasort@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sarah E. Fox, B.A.    734-232-8005    sarasort@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Steven W. Bruch, M.D. University of Michigan

Responsible Party: Steven W. Bruch, Associate Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT03159754     History of Changes
Other Study ID Numbers: HUM00103791
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Ciprofloxacin
Piperacillin
Piperacillin, tazobactam drug combination
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors