Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

NCT ID: NCT02916134

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-12
• Study Completion Date: 2019-12-08

Brief Summary

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

Detailed Description

The study will include patients aged 16 and over, with a first admission with right iliac fossa pain and a raised white cell count or C-reactive protein. Patients will be randomised electronically in a 1:1 ratio either to undergo emergency appendectomy or to receive intravenous antibiotics as an inpatient, until clinical and biochemical improvement is observed, followed by outpatient oral antibiotics. Those who have surgery will have 3 post-operative doses of intravenous antibiotics, unless perforation was identified at the time of surgery, in which case, microbiology will be contacted to advise regarding antibiotic choice and duration. Follow-up by telephone interview will be at 1 week, 1, 3 and 12-month intervals.

Conditions

Appendicitis

Study Design

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

Study Groups

Operative Intervention

Laparoscopic +/- open appendicectomy, with antibiotics at induction and 3 further doses of intravenous antibiotics. Co-amoxiclav, or cefuroxime and metronidazole if previous rash-allergy to penicillin.

Group Type: ACTIVE_COMPARATOR

Laparoscopic +/- Open Appendicectomy

Intervention Type: PROCEDURE

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.

Antibiotic Treatment

Intravenous antibiotics until clinical improvement and then 5 further days of oral antibiotics. Co-amoxiclav, or if rash-allergy to penicillin, cefuroxime and metronidazole.

Group Type: EXPERIMENTAL

Antibiotic treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Right iliac fossa pain
• 1st episode in the past 1 year
• Raised WCC or CRP
• Fluent in English

Exclusion Criteria

• History of inflammatory bowel disease or appendectomy
• B-HCG positive
• Significant co-morbidities
• Complicated appendicitis as proven by ultrasound, CT or MRI
• Anaphylaxis to penicillin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arnold Hill

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnold K Hill

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

16/59

Identifier Type: -

Identifier Source: org_study_id