Optimal Care of Complicated Appendicitis

NCT ID: NCT03159754

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2020-03-26

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.

{{{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.}}}}

Conditions

Appendicitis; Perforated Appendicitis; Ruptured Appendicitis; Complicated Appendicitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Appendectomy

Group Type: EXPERIMENTAL

Early Appendectomy

Intervention Type: PROCEDURE

Removal of the appendix within 24 hours of admission

Antibiotics

Intervention Type: DRUG

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

Interval Appendectomy

Group Type: EXPERIMENTAL

Interval Appendectomy

Intervention Type: PROCEDURE

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

Antibiotics

Intervention Type: DRUG

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

No Appendectomy

Group Type: EXPERIMENTAL

Antibiotics

Intervention Type: DRUG

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

Interventions

Early Appendectomy

Removal of the appendix within 24 hours of admission

Intervention Type: PROCEDURE

Interval Appendectomy

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

Intervention Type: PROCEDURE

Antibiotics

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

Intervention Type: DRUG

Other Intervention Names

Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Steven W. Bruch

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven W. Bruch, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00103791

Identifier Type: -

Identifier Source: org_study_id