CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) , Hall, Crawley et al, 2021

Andy

Andy

Senior Member (Voting rights)
Objective To establish the feasibility of a multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy in children with uncomplicated acute appendicitis.

Design Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.

Setting Three specialist paediatric surgery centres in the UK.

Patients Children (aged 4–15 years) with a clinical diagnosis of uncomplicated acute appendicitis.

Interventions Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).

Main outcome measures Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course.

Results Fifty per cent of eligible participants (95% CI 40 to 59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.

Conclusion Recruitment to a randomised controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.
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Open access, https://adc.bmj.com/content/early/2021/01/12/archdischild-2020-320746
 
Main outcome measures Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course.
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I wonder if she is still trying to play tricks with the ethics committees in doing a feasibility study that will suddenly become a full study
 
Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.
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She may be playing tricks, but with 'more participants having perforated appendicitis than anticipated', I expect this feasibility trial will be put to one side and there will be another roll of the dice for the main trial.

a non-operative treatment pathway
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Cheaper for the health system/insurers than an operation no doubt, but at least the children in the study get antibiotics and monitoring - rather than thinking happy thoughts about healthy appendices and an investigation of what past trauma or personality failing has caused the problem.

I suppose a pandemic is a perfect time to investigate non-operative alternatives to surgeries - as people have a good incentive to not go into hospital. Possibly it won't be so easy to recruit with everyone vaccinated.
 
I am shocked speechless. Perforated appendicitis is no joke. My Mother in Law died at age 75 due to adhesions on the bowel caused by a perforated appendix operation when she was 7 causing torsion and tissue death.

It tells you the quality of the doctor when they publish results that are said to be "be safe and adverse event profiles acceptable" despite the number of perforated appendicitis being higher than anticipated.

It is proof that this is not patient centred research.
 
Cheshire said:
Is she at least leaving the CFS field?
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I'm afraid she's just showing that children's wellbeing is not what she primarily cares for also in other illnesses than ME.
While there are several similar ongoing trials comparing non-operative treatment with appendicectomy for children with uncomplicated acute appendicitis,18 19 none are recruiting in the UK. We continue to believe that a UK trial is important to understand the comparative effectiveness of these two very different treatments and the comparative cost-effectiveness within the NHS.
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Are their beliefs good reasons why not to wait for the results of these other studies first?

But look how generous they are:

Discharge assessment and follow-up
Part way through the study, we introduced an incentive of a £10 shopping voucher to participants who completed all future follow-up assessments. Of the 3-month follow-up appointments, 47 were not incentivised and were completed by 39 participants (83%, 95% CI 72% to 93%), whereas 7 were incentivised and all 7 were completed (100%, 95% CI 59% to 100%).

Of the 6-month follow-up appointments, 34 were not incentivised and were completed by 28 participants (83%, 95% CI 65% to 93%) and 19 were incentivised and were completed by 17 participants (89%, 95% CI 67% to 99%).
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Snowdrop said:
Question for anyone who knows: Is there no obligation to say where the funding comes from for a study?
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It's in the footnotes:

Funding
This study is part of a larger project, CONTRACT, funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (grant number: 14/192/90; http://www.nets.nihr.ac.uk/projects/hta/1419290). JMB is supported by the NIHR Bristol Biomedical Research Centre and is an NIHR Senior Investigator.
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I did a quick google search and found this paper from April 2020:
Diagnosis and treatment of acute appendicitis: 2020 update of the WSES Jerusalem guidelines
https://wjes.biomedcentral.com/articles/10.1186/s13017-020-00306-3
which has a section on treatment with antibiotics in non complicated acute appendicitis, including in children. It's not a new idea, and seems to be recommended in some cases.
 
A bit confused by this, but it seems like it's a NIHR report on this study.

Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT

This study suggested that a multicentre trial comparing the effectiveness of broad-spectrum antibiotics and active observation to appendicectomy is feasible.

Open access, https://www.journalslibrary.nihr.ac.uk/hta/hta25100#/abstract
 
Sid said:
It's amazing what these people are willing to do to patients just to save the NHS some money.
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So, only 50% of suitable patients were willing to enter the trial, not surprising.

In their future work:
"Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved."

So, a few more hoops to go through before a larger trial, which will hopefully reduce the numbers with perforated appendices.
 
From the full HTA report, Results:

"Of the 28 participants randomised to appendicectomy, 27 received the intervention. Seventeen were found to have uncomplicated acute appendicitis, but eight had perforated appendicitis and two had a histologically normal appendix. The median length of stay in hospital was 65 (range 20–196) hours after randomisation. Three children (11%) were re-admitted to hospital, following initial discharge, for investigation and/or treatment of potential complications related to appendicectomy. All were treated with intravenous antibiotics and one received percutaneous abscess drainage. Two further children received oral antibiotics for a wound infection.

Of the 29 participants randomised to non-operative treatment, 27 received the intervention. Nineteen (70%) of these participants responded to initial non-operative treatment and were discharged home a median of 61 (range 34–125) hours following randomisation. The remaining eight underwent appendicectomy during initial hospital admission because of parental choice (withdrawal from treatment allocation, n = 1), clinical deterioration (n = 6) and no improvement at 48 hours (n = 1). Among these eight, four had simple acute appendicitis and four had perforated appendicitis. Among the 19 participants who initially responded to non-operative treatment, seven developed recurrent appendicitis after hospital discharge and underwent appendicectomy.
 
So, for the ones who were originally allocated to antibiotics, 28
  • 8 had the operation (4 perforated, 4 acute appendicitis)
  • 19 were discharged after 61 hrs (34-125)
  • Of the 19 discharged, 7 were readmitted at a later date and had appendectomies then.
For those who had appendectomies initially, 27
  • 8 perforated
  • 17 uncomplicated acute appendicitis
  • 2 normal histology
Average hospital stay 65 hrs (20-196), 3 were readmitted for iv antibiotics
 
Curious.

For someone whose measure of function seemed to be purely bums on the school seat approach this seems to be the opposite.

A sibling of mine had "grumbling appendicitis" as they became a teen. Several episodes of time off school - not all requiring hospitalization, several hospital stays & eventually an appendectomy.

A fair bit of school time lost, high cost to my parents who both worked at the time and general family upheaval.

Quite a few rounds of antibiotics and several hospital stays that all ended in an appendectomy anyway. It can't have saved the health authority money in the long run.

I thought "individualised, patient centred care" was the latest BPS catchphrase. In which case why not let the surgeon crack on and do that, based on his experience and knowledge of each individual case?
 
N=1 but my partner had an undiagnosed perforated appendix. I insisted he needed antibiotics and then insisted he needed more. The hole in his appendix was discovered some months later. He still has problems years later due to suspected adhesions.
I’m suspicious that this is simply a money-saving exercise.
 
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