Clinical Trial: Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Beaumont Hospital

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Beaumont Hospital

Dates:
Date Received: August 29, 2016
Date Started: August 2016
Date Completion: August 2019
Last Updated: November 23, 2016
Last Verified: November 2016