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Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

NCT02916134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-07-13

No results posted yet for this study

Summary

This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.

Conditions

  • Appendicitis

Interventions

PROCEDURE

Laparoscopic +/- Open Appendicectomy

Laparoscopic +/- open appendicectomy , with antibiotics at induction (intravenous co-amoxiclav 1.2g, or if penicillin allergic, cefuroxime 1.5g + metronidazole 500mg ), followed by 3 further intravenous doses of the same antibiotic. If a perforation is identified at the time of surgery, microbiology will be contacted regarding choice and duration of of antibiotic.

DRUG

Antibiotic treatment

Intravenous co-amoxiclav 1.2g three times daily, then 625mg, orally three times daily. If penicillin allergic, intravenous cefuroxime 1.5g three times daily + metronidazole 500mg three times daily, then oral cefuroxime 500mg twice daily + oral metronidazole 400mg three times daily. The patient will receive inpatient intravenous antibiotics until sufficient clinical improvement is noted by the surgical team, who will be assessing the patient twice daily. After discharge the patient will receive 5 further days of oral antibiotics.

Sponsors & Collaborators

  • Beaumont Hospital

    lead OTHER

Principal Investigators

  • Arnold K Hill · Beaumont Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2019-12-08
Completion
2019-12-08

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916134 on ClinicalTrials.gov