Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Procedure: Laparoscopic +/- Open Appendicectomy; Drug: Antibiotic treatment

• Registration Number: NCT02916134
• Lead Sponsor: Beaumont Hospital

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.

Study Timeline

• Study First Submitted: 2016-08-29
• Study Start: 2016-09-12
• Study First Submitted QC: 2016-09-24
• Study First Posted: 2016-09-27
• Primary Completion: 2019-12-08
• Study Completion: 2019-12-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative Intervention	Laparoscopic +/- Open Appendicectomy	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.
Antibiotic Treatment	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.

Primary Outcome Measures

Name	Time	Method
Successful treatment of appendicitis	1 year post enrollment	Successful treatment is defined as the resolution of appendicitis resulting in discharge from the hospital and no recurrent appendicitis during the one-year follow-up. The number of patients requiring surgery for appendicitis in the non-operative group will be measured.

Secondary Outcome Measures

Name	Time	Method
Clostridium difficile infection	1 year post enrollment	Confirmed symptomatic clostridium difficile infection occurring within one year of enrolment. Any patient who presents with diarrhea during the follow-up period or reports diarrhea during assessment with the follow-up questionnaire will be asked to provide a stool sample which will be tested for clostridium difficile toxins.
Need for re-admission or repeat imaging	1 year post enrollment	Recurrence or non-resolution of abdominal pain requiring re-admission or re-imaging after discharge and within one year of enrolment. The number of patients who need to be re-admitted to hospital for abdominal pain or require ultrasound, MRI or CT for investigation of abdominal pain during the one year follow-up will be measured.
Quality of life Questionnaire taken over the year after recruitment	1 year post enrollment	Quality of life will be measured in both treatment groups at 1 week, 1 month, 3 months and 1 year post enrolment. Quality of life will be measured using the EQ-5D-3L validated quality of life questionnaire.
Complication of treatment	1 year post enrollment	Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.
Cost evaluation	1 year post enrollment	Associated cost will be evaluated in the antibiotics only, surgery and recurrence groups
Recurrence of appendicitis	1 year post enrollment	Confirmed appendicitis occurring after discharge and within one year of enrolment. The number of patients with appendicitis confirmed on either imaging or pathology will be measured.

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Dublin, Ireland