Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

Appendicitis Clinical Trial

— COMMA  

Official title:

Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916134
• Other study ID #: 16/59
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Est. completion date: December 8, 2019

Study information

• Verified date: July 2020
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 8, 2019
• Est. primary completion date: December 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

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.

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Beaumont Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complication of treatment	Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.	1 year post enrollment
Secondary	Cost evaluation	Associated cost will be evaluated in the antibiotics only, surgery and recurrence groups	1 year post enrollment