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Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis (COMMA)

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ClinicalTrials.gov Identifier: NCT02916134
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Arnold Hill, Beaumont Hospital

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

Condition or disease Intervention/treatment Phase
Appendicitis Procedure: Laparoscopic +/- Open Appendicectomy Drug: Antibiotic treatment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Complication of treatment [ Time Frame: 1 year post enrollment ]
    Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916134


Contacts
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Contact: Siun M Walsh siunwalsh@rcsi.ie

Locations
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Ireland
Beaumont Hospital Recruiting
Dublin, Ireland, D9
Contact: Arnold K Hill, MCh, FRCSI    +35318093760    adkhill@rcsi.ie   
Sponsors and Collaborators
Beaumont Hospital
Investigators
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Principal Investigator: Arnold K Hill Beaumont Hospital

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Responsible Party: Arnold Hill, Professor of Surgery, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT02916134     History of Changes
Other Study ID Numbers: 16/59
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Intraabdominal Infections
Infection
Appendicitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Metronidazole
Penicillins
Cefuroxime
Cefuroxime axetil
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action