Optimal Care of Complicated Appendicitis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03159754

Enrollment

Registered

2017-05-19

Start date

2017-06-29

Completion date

2020-03-26

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Complicated Appendicitis, Perforated Appendicitis, Ruptured Appendicitis

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.}}}}

Interventions

PROCEDUREEarly Appendectomy

Removal of the appendix within 24 hours of admission

PROCEDUREInterval Appendectomy

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

DRUGAntibiotics

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Cost of Care	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

Measure	Time frame	Description
Parents Away From Work	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.
Duration of Antibiotic Therapy	During index/initial hospitalization (generally not more than 5-6 weeks)	Duration of antibiotic therapy measured in days
Length of Stay	During index/initial hospitalization (generally not more than 5-6 weeks)	Length of all hospital stays measured in days
Complications	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
Number of Radiographic Imaging Studies	During index/initial hospitalization (generally not more than 5-6 weeks)	Number of radiographic imaging studies including ultrasound, CT, and MRI
Quality of Life (PedsQL)	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.
Recurrent Appendicitis	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.
Number of Percutaneous Drainage Procedures	During index/initial hospitalization (generally not more than 5-6 weeks)	Number of persons with differing numbers of percutaneous drainage procedures

Countries

United States

Participant flow

Participants by arm

Arm	Count
Early Appendectomy Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	24
Interval Appendectomy Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	12
No Appendectomy Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	4
Total	40

Baseline characteristics

Characteristic	Total	No Appendectomy	Interval Appendectomy	Early Appendectomy
Age, Customized 13-17 years	11 Participants	1 Participants	1 Participants	9 Participants
Age, Customized 5-7 years	12 Participants	2 Participants	6 Participants	4 Participants
Age, Customized 8-12 years	17 Participants	1 Participants	5 Participants	11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	0 Participants	1 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants	4 Participants	11 Participants	21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Other American Indian or Alaska Native	2 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Other Asian	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Other Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Other More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Other Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Other Unknown or Not Reported	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Other White	35 Participants	3 Participants	12 Participants	20 Participants
Region of Enrollment United States	40 Participants	4 Participants	12 Participants	24 Participants
Sex: Female, Male Female	12 Participants	0 Participants	3 Participants	9 Participants
Sex: Female, Male Male	28 Participants	4 Participants	9 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 24	0 / 12	0 / 4
other Total, other adverse events	10 / 24	5 / 12	2 / 4
serious Total, serious adverse events	3 / 24	2 / 12	0 / 4

Outcome results

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.

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.

Population: No cost data for any participants was able to be procured. Thus this outcome could not be achieved or analyzed in any fashion.

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