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Completed

NCT Number: NCT02916134

Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

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

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Key information

Conditions

Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Hospital

Dublin, D9, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic +/- Open Appendicectomy

Procedure

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.

Antibiotic treatment

Drug

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 outcomes

  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 outcomes

  1. 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 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.

  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.

  6. Cost evaluation

    Time frame: 1 year post enrollment

    Associated cost will be evaluated in the antibiotics only, surgery and recurrence groups

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Registry information

Acronym: COMMA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2016
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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