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Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis (COMMA)

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ClinicalTrials.gov Identifier: NCT02916134
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Arnold Hill, Beaumont Hospital

Tracking Information
First Submitted Date  ICMJE August 29, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE September 12, 2016
Actual Primary Completion Date December 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
Successful treatment of appendicitis [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • Recurrence of appendicitis [ Time Frame: 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.
  • Clostridium difficile infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year post enrollment ]
    Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.
  • Cost evaluation [ Time Frame: 1 year post enrollment ]
    Associated cost will be evaluated in the antibiotics only, surgery and recurrence groups
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
  • Late recurrence of appendicitis [ Time Frame: 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.
  • Clostridium difficile infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year post enrollment ]
    Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
Official Title  ICMJE Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Laparoscopic +/- Open Appendicectomy
  • 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.
    Intervention: Drug: Antibiotic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2019)
186
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2016)
400
Actual Study Completion Date  ICMJE December 8, 2019
Actual Primary Completion Date December 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916134
Other Study ID Numbers  ICMJE 16/59
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arnold Hill, Beaumont Hospital
Study Sponsor  ICMJE Beaumont Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnold K Hill Beaumont Hospital
PRS Account Beaumont Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP