Optimal Care of Complicated Appendicitis

Appendicitis Clinical Trial

Official title:

Optimal Care of Complicated Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159754
• Other study ID #: HUM00103791
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2017
• Est. completion date: March 26, 2020

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

{{{While 40 participants were enrolled as intended, and some data was collected from them, a combination of staff turnover and subsequent resource constraints did not permit the analysis originally intended. Thus, results data is shown comparing the early appendectomy participants against the other two arms combined.}}}}

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Complicated Appendicitis
• Perforated Appendicitis
• Ruptured Appendicitis

Intervention

Procedure:
• Early Appendectomy
Removal of the appendix within 24 hours of admission
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 larger operation	During index/initial hospitalization (generally not more than 5-6 weeks)
Secondary	Parents Away From Work	Parents away from work measured in days is presented here. The intention was to collect "missed activity days" for children as well as missed parent work days. However, the question to capture this information referred to school and was determined to be too inconsistent with the way the question may have been interpreted when the survey was given to code reliably.	During index/initial hospitalization (generally not more than 5-6 weeks)
Secondary	Duration of Antibiotic Therapy	Duration of antibiotic therapy measured in days	During index/initial hospitalization (generally not more than 5-6 weeks)
Secondary	Length of Stay	Length of all hospital stays measured in days	During index/initial hospitalization (generally not more than 5-6 weeks)
Secondary	Number of Percutaneous Drainage Procedures	Number of persons with differing numbers of percutaneous drainage procedures	During index/initial hospitalization (generally not more than 5-6 weeks)
Secondary	Number of Radiographic Imaging Studies	Number of radiographic imaging studies including ultrasound, CT, and MRI	During index/initial hospitalization (generally not more than 5-6 weeks)
Secondary	Quality of Life (PedsQL)	Original QOL outcome measure listed was: Quality of life measured by PedsQL 2 years following discharge. Two year data collected was insufficient to allow for any analysis. One month GI QOL data collected, also listed in the protocol, is shown below. GI QoL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. Peds QL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life.	1 month; for GI QOL; 2 years for Peds QL
Secondary	Recurrent Appendicitis	Number of persons who experience recurrent appendicitis requiring hospitalization. Because the early appendectomy arm participant by definition have no appendix to infect after surgery, they are not shown below.	2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.)