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Completed

NCT Number: NCT03159754

Optimal Care of Complicated Appendicitis

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.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.}}}}

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early appendectomy

Procedure

Removal of the appendix within 24 hours of admission

interval appendectomy

Procedure

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

Antibiotics

Drug

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

Other names: Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole

Primary outcomes

  1. Overall Cost of Care

    Time frame: 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.

    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.

Secondary outcomes

  1. Complications

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

    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

  2. Parents Away From Work

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

    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.

  3. Duration of Antibiotic Therapy

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

    Duration of antibiotic therapy measured in days

  4. Length of Stay

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

    Length of all hospital stays measured in days

  5. Number of Percutaneous Drainage Procedures

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

    Number of persons with differing numbers of percutaneous drainage procedures

  6. Number of Radiographic Imaging Studies

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

    Number of radiographic imaging studies including ultrasound, CT, and MRI

  7. Quality of Life (PedsQL)

    Time frame: 1 month; for GI QOL; 2 years for Peds QL

    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.

  8. Recurrent Appendicitis

    Time frame: 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.)

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 19, 2017
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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