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
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Procedure: Laparoscopic +/- Open Appendicectomy Drug: Antibiotic treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Contact: Siun M Walshfirstname.lastname@example.org|
|Dublin, Ireland, D9|
|Contact: Arnold K Hill, MCh, FRCSI +35318093760 email@example.com|
|Principal Investigator:||Arnold K Hill||Beaumont Hospital|