AppendicitisCOMMANCT02916134
Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
A study testing Laparoscopic +/- Open Appendicectomy and Antibiotic treatment in people with Appendicitis, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Laparoscopic +/- Open Appendicectomy and Antibiotic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteIreland
- Study dates
- 12 Sep 2016to 8 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right iliac fossa pain
- 1st episode in the past 1 year
- Raised WCC or CRP
- Fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- Laparoscopic +/- Open Appendicectomy, Antibiotic treatment
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic +/- Open AppendicectomyProcedure or surgery
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 treatmentDrug
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 group | Role | What they receive |
|---|---|---|
| Operative Intervention | Active comparator | 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. Receives: Procedure: Laparoscopic +/- Open Appendicectomy |
| Antibiotic Treatment | Experimental | Intravenous antibiotics until clinical improvement and then 5 further days of oral antibiotics. Co-amoxiclav, or if rash-allergy to penicillin, cefuroxime and metronidazole. Receives: Drug: Antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment of appendicitis
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.
Measured: 1 year post enrollment
Secondary outcomes (6)
Recurrence of appendicitis
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.
Measured: 1 year post enrollment
Clostridium difficile infection
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.
Measured: 1 year post enrollment
Need for re-admission or repeat imaging
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.
Measured: 1 year post enrollment
Quality of life Questionnaire taken over the year after recruitment
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.
Measured: 1 year post enrollment
Complication of treatment
Complications of treatment including surgical site infection, abscess formation and ongoing pain will be measured.
Measured: 1 year post enrollment
Cost evaluation
Associated cost will be evaluated in the antibiotics only, surgery and recurrence groups
Measured: 1 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start12 Sep 2016
- Primary completion8 Dec 2019
- Study completion8 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnold Hill, Beaumont Hospital
- Investigators
- Arnold K Hill, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916134
- Sponsor's protocol ID
- 16/59
- Acronym
- COMMA
- Status last verified
- Jul 2020
- First submitted
- 29 Aug 2016
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
- ClinicalTrials.gov ID
- NCT02916134
- Acronym / sponsor ID
- COMMA / 16/59
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 8 Dec 2019 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative Intervention | Active comparator | Procedure: Laparoscopic +/- Open AppendicectomyLaparoscopic +/- 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. |
| Antibiotic Treatment | Experimental | Drug: Antibiotic treatmentIntravenous antibiotics until clinical improvement and then 5 further days of oral antibiotics. Co-amoxiclav, or if rash-allergy to penicillin, cefuroxime and metronidazole. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Right iliac fossa pain
- 1st episode in the past 1 year
- Raised WCC or CRP
- Fluent in English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic +/- Open AppendicectomyLaparoscopic +/- 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. | Procedure or surgery | Operative Intervention |
| Antibiotic treatmentIntravenous 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. | Drug | Antibiotic Treatment |
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.
6 secondary outcomes
Recurrence of appendicitis
Time frame: 1 year post enrollment
Clostridium difficile infection
Time frame: 1 year post enrollment
Need for re-admission or repeat imaging
Time frame: 1 year post enrollment
Quality of life Questionnaire taken over the year after recruitment
Time frame: 1 year post enrollment
Complication of treatment
Time frame: 1 year post enrollment
Cost evaluation
Time frame: 1 year post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold K Hill principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic +/- Open Appendicectomy and Antibiotic treatment in people with Appendicitis, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful treatment of appendicitis (time frame: 1 year post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.