Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis (COMMA)

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

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: Procedure: Laparoscopic +/- Open Appendicectomy; Drug: Antibiotic treatment

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 Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D9
    • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful treatment of appendicitis	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.	1 year post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of appendicitis	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.	1 year post enrollment
Clostridium difficile infection	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.	1 year post enrollment
Need for re-admission or repeat imaging	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.	1 year post enrollment
Quality of life Questionnaire taken over the year after recruitment	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.	1 year post enrollment
Complication of treatment	Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.	1 year post enrollment
Cost evaluation	Associated cost will be evaluated in the antibiotics only, surgery and recurrence groups	1 year post enrollment

Collaborators and Investigators

• Sponsor: Beaumont Hospital
• Investigators: Principal Investigator: Arnold K Hill, Beaumont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2016
• Primary Completion (Actual): December 8, 2019
• Study Completion (Actual): December 8, 2019

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 24, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 16/59

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO