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Optimal Care of Complicated Appendicitis

Primary Purpose

Appendicitis, Perforated Appendicitis, Ruptured Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Appendectomy
Interval Appendectomy
Antibiotics
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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90% specificity for complicated appendicitis based on unpublished institutional data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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Early Appendectomy

Interval Appendectomy

No Appendectomy

Arm Description

Outcomes

Primary Outcome Measures

Overall cost of care
Total health care cost starting from time of admission

Secondary Outcome Measures

Complications
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
Time away from activity/parents away from work
Time away from activity/parents away from work measured in days
Duration of antibiotic therapy
Duration of antibiotic therapy measured in days
Length of stay
Length of hospital all hospital stays measured in days
Number of percutaneous drainage procedures
Number of percutaneous drainage procedures
Number of radiographic imaging studies
Number of radiographic imaging studies including ultrasound, CT, and MRI
Quality of life
Quality of life measured by PedsQL 2 years following discharge
Recurrent appendicitis
Number of persons who experience recurrent appendicitis requiring hospitalization

Full Information

First Posted
May 17, 2017
Last Updated
October 31, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03159754
Brief Title
Optimal Care of Complicated Appendicitis
Official Title
Optimal Care of Complicated Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
May 13, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Perforated Appendicitis, Ruptured Appendicitis, Complicated Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Appendectomy
Arm Type
Experimental
Arm Title
Interval Appendectomy
Arm Type
Experimental
Arm Title
No Appendectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Early Appendectomy
Intervention Description
Removal of the appendix within 24 hours of admission
Intervention Type
Procedure
Intervention Name(s)
Interval Appendectomy
Intervention Description
Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Other Intervention Name(s)
Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole
Intervention Description
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Primary Outcome Measure Information:
Title
Overall cost of care
Description
Total health care cost starting from time of admission
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complications
Description
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
Time Frame
During index/initial hospitalization (generally not more than 5-6 weeks)
Title
Time away from activity/parents away from work
Description
Time away from activity/parents away from work measured in days
Time Frame
During index/initial hospitalization (generally not more than 5-6 weeks)
Title
Duration of antibiotic therapy
Description
Duration of antibiotic therapy measured in days
Time Frame
During index/initial hospitalization (generally not more than 5-6 weeks)
Title
Length of stay
Description
Length of hospital all hospital stays measured in days
Time Frame
During index/initial hospitalization (generally not more than 5-6 weeks)
Title
Number of percutaneous drainage procedures
Description
Number of percutaneous drainage procedures
Time Frame
During index/initial hospitalization (generally not more than 5-6 weeks)
Title
Number of radiographic imaging studies
Description
Number of radiographic imaging studies including ultrasound, CT, and MRI
Time Frame
During index/initial hospitalization (generally not more than 5-6 weeks)
Title
Quality of life
Description
Quality of life measured by PedsQL 2 years following discharge
Time Frame
2 years
Title
Recurrent appendicitis
Description
Number of persons who experience recurrent appendicitis requiring hospitalization
Time Frame
2 years????????????

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria At least 1 of the following CT or MRI findings: Peri-appendicular abscess Extruded appendicolith Visible hole in appendiceal wall Free peritoneal air OR 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 Exclusion Criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven W. Bruch, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Optimal Care of Complicated Appendicitis

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