Restricted Duration of SOC Antibiotic Use for Appendicitis

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Appendicitis
Restricted Duration of SOC Antibiotic Use - Other
Eligibility
18+
All Sexes
Eligible conditions
Appendicitis

Study Summary

This study is evaluating whether decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Restricted Duration of SOC Antibiotic Use will improve 3 primary outcomes in patients with Appendicitis. Measurement will happen over the course of Up to 40 days after appendicitis surgery.

Day 30
Incidence of Infectious/Antibiotic Complications
Number of participant deaths
Day 40
Number of participants with no antibiotic related adverse effects

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Liberal Post-Operative Antibiotics Group
Restricted Post-Operative Antibiotics Group

This trial requires 2275 total participants across 2 different treatment groups

This trial involves 2 different treatments. Restricted Duration Of SOC Antibiotic Use is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Restricted Post-Operative Antibiotics Group
Other
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
Liberal Post-Operative Antibiotics Group
Other
Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after appendicitis surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 30 days after appendicitis surgery for reporting.

Who is running the study

Principal Investigator
D. D. Y.
Prof. Daniel Dante Yeh, Professor
University of Miami

Closest Location

University of Miami - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years
Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis
Working telephone number or reliable method to contact patient after hospital discharge

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for appendicitis?

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Appendectomy remains the benchmark treatment for acute appendicitis, and is currently the standard of care for all degrees of disease. Surgery is also used for children with non-septic appendicitis, but its indications for children with septic appendicitis are in dispute. Other treatments are used for uncomplicated appendicitis in children with medical contraindications for surgery.

Unverified Answer

Can appendicitis be cured?

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Appendicitis cannot be cured; the pain will come back if the condition is not treated aggressively, as appendicitis is not only painful, but also dangerous and may result in sepsis and/or perforation of the appendix. Untreated appendicitis can cause a protracted illness, including chronic pelvic pain and infertility problems. This condition can lead to a lower quality of life, as the person feels that his life is limited and can be frustrated by the illness. Aspects of the cure, such as antibiotic-based or surgery-based treatment are of interest to the patient. The patient will decide how the illness is treated.

Unverified Answer

How many people get appendicitis a year in the United States?

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Almost 100,000 children in the United States are diagnosed with appendicitis each year. Appendicitis is among the most common cause of abdominal pain in children. Primary care physicians, surgeons, and pediatricians must be informed that appendix is a common cause of abdominal pain in children.

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What are the signs of appendicitis?

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Patients in whom these signs are present should have laparoscopy as a definitive investigation, since this reduces cost and discomfort and avoids the need for formal treatment of both appendicitis and diverticular disease.

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What is appendicitis?

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It is estimated that appendectomy is performed approximately 12.5 million times-a rate of 17.7%. Appendicitis is the most common presentation of abdominal pain in children and adolescents. Although the exact incidence of appendiceal disease is difficult to gauge due to the lack of reporting, appendicitis occurs more frequently in boys than girls and affects the right appendicular region approximately four times more often than the left. The incidence of acute appendicitis in older children and adults is about equal. Appendicitis is most common in the peritoneal lining, a situation known as appendiceal suppuration and is characterized by high fever, local tenderness, and general somatic and psychiatric complaints.

Unverified Answer

What causes appendicitis?

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Appendicitis can be prevented by the oral administration of acetaminophen before surgery. The use of antibiotics before surgery may not be necessary after children are weaned from breast milk. Complications of acute appendicitis may occur particularly in children who have had a previous episode.

Unverified Answer

Who should consider clinical trials for appendicitis?

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Consideration of clinical trials could improve the treatment and outcome of patients with appendicitis compared with traditional treatment, which usually consists of aspirin and nonsteroidal anti-inflammatory drugs.

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What is the average age someone gets appendicitis?

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In our study, 58% of patients had an adult. In this selected group, all patients with appendicitis were treated with conservative treatment regardless of the clinical presentation. Findings from a recent study of this study suggest surgeons should not be limiting their use of conservative treatment for appendicitis to patients under 65 years of age if there is no clinical signs of high-grade appendicitis.

Unverified Answer

What are the latest developments in restricted duration of soc antibiotic use for therapeutic use?

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A review of recent publications demonstrated the usefulness of using short courses of antibiotics, a strategy that is widely practised and proven to be safe. A limited duration of antibiotic use is safe in uncomplicated appendicitis. Further studies, carried out in a large homogeneous cohort, are needed to establish the applicability of the strategy and will help the optimal durations in all the clinical situations, including the children, where antibiotics are still recommended.

Unverified Answer

Has restricted duration of soc antibiotic use proven to be more effective than a placebo?

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Recent findings showed no difference in outcome and an increased rate of side effects and cost of antibiotics to those who received the active therapy for two days. On the basis of the results of this study, the recommendations for the use of antibiotics in appendicitis cannot be changed, but a restriction in duration from the previous recommendation of five days to two days seems optimal.

Unverified Answer

What is the latest research for appendicitis?

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The latest research for appendicitis is in the form of recent trends in the incidence of the disease. It is clear that the incidence of appendicitis in the US is rising, which may be due to a number of factors, including increased use of healthcare insurance, increased awareness of the illness, and changes in the way physicians and patients seek treatment for appendicitis.\n

Unverified Answer

Have there been other clinical trials involving restricted duration of soc antibiotic use?

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There have been several previous clinical trials in an effort to determine the duration of soc antibiotics use that yielded conflicting recommendations. Most researchers have determined that soc antibiotics should last 15 days before prescribing them for prophylaxis. With the current knowledge of the mechanism of action of soc and the current clinical experience, further prospective clinical trials will need to be conducted to gain further insight into the optimal treatment of appendicitis from soc antibiotic use.

Unverified Answer
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