RecruitingPhase 3ACTRN12618001229268

Antibiotics versus key-hole surgery for successful treatment of acute appendicitis

Laparoscopic Appendicectomy versus Antibiotics for Resolution of Radiologically Confirmed Acute Uncomplicated Appendicitis: A Multi-Centre Randomised Pilot Tria

Sponsor

Townsville Hospital

Enrollment

40 participants

Start Date

Dec 1, 2018

Study Type

Interventional

Conditions

Appendicitis

Summary

Appendicitis has usually been treated with an operation (i.e. appendicectomy) for the last 125 years however recent studies have suggested antibiotics may be an effective treatment strategy in a subset of patients. While many recent studies have examined this, only one large rigorous clinical trial has been performed (the 2015 APPAC trial), itself with multiple caveats which limit generalizability to the Australian population. Another large trial, the CODA trial in the United States, also is underway however it too will be difficult to generalise this trial to the Australian setting. We aim to conduct a pilot trial to assess the feasibility and acceptability of a treatment protocol designed to compare antibiotics with laparoscopic appendicectomy for the treatment of mild acute uncomplicated appendicitis. The ultimate goal of this trial would be to perform a large, multi-centre trial in the future.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is for adults aged 18 to 50 who have been diagnosed with acute appendicitis — inflammation of the appendix — that has been confirmed on ultrasound or CT scan and appears uncomplicated (no rupture, abscess, or perforation). For over a century, appendicitis has been treated with surgery to remove the appendix. However, recent research suggests that for mild, uncomplicated cases, a course of antibiotics might work just as well for many patients, avoiding the need for an operation. Participants are randomly assigned to either receive antibiotics (given intravenously in hospital, then orally at home) or to proceed with the standard keyhole surgery (laparoscopic appendicectomy). This is a pilot study, meaning its main purpose is to test whether the design is practical and acceptable before a larger trial is run. All participants are closely monitored, and anyone who does not improve on antibiotics can still have surgery. You may be eligible if you are aged 18 to 50, have confirmed uncomplicated appendicitis on imaging, are medically stable, and have no significant health conditions that would exclude you from either antibiotics or surgery. People with complicated appendicitis, a faecolith (hardened stool in the appendix), pregnancy, diabetes, immune problems, heart disease, or previous bowel surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Antibiotics: All patients will receive intravenous ceftriaxone 1g twice per day and intravenous metronidazole 500mg twice per day, in keeping with the Australian Therapeutic Guidelines for severe i

Antibiotics: All patients will receive intravenous ceftriaxone 1g twice per day and intravenous metronidazole 500mg twice per day, in keeping with the Australian Therapeutic Guidelines for severe intra-abdominal infection secondary to perforated viscus. The patients would be re-evaluated within 12 to 24 hours of receiving the antibiotics and monitored at least daily. At least daily blood test will be performed. If the patient has not met any failure criteria after 48 hours of treatment with IV antibiotics (i.e. at least 2 doses of ceftriaxone and 4 doses of metronidazole), the patient will be transitioned to a 5 day course of oral Augmentin DuoForte (amoxicillin 875mg + clavulanic acid 125mg) twice per day as an inpatient or an outpatient. A patient who is hypersensitive or has a documented adverse drug reaction to the study medications will not be recruited for the study. Failure of antibiotic therapy will be at the discretion of the treating physician. The treating physician will have to document the reason for failure: persistent tachycardia, persistent fever, worsening laboratory results (including white blood cell count or CRP), non-resolution or worsening of pain, signs of peritonitis, signs of shock, patient preference to proceed with surgery or other.