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AppendicitisPhase 4APACNCT02848820

Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children

A Phase 4 study testing Augmentin + Gentamicin and Appendectomy in people with Appendicitis, run by Ramon Gorter at 15 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

OBJECTIVE The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications… Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Appendicitis
What is being tested?
Augmentin + Gentamicin and Appendectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
15 sitesNetherlands
Study dates
Dec 2016to Dec 2024
Phase
Phase 4
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 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 7-17 years
  • Radiologically confirmed simple appendicitis, defined as:
  • Clinical findings:
  • Unwell, but not generally ill
  • Localized tenderness in the right iliac fossa region
  • Normal/hyperactive bowel sounds
Show all 15Show fewer
  • No guarding
  • No mass palpable
  • Ultrasonography:
  • Incompressible appendix with an outer diameter of ≥6 mm
  • Hyperaemia within the appendiceal wall
  • Without faecolith
  • Infiltration of surrounding fat
  • No signs of perforation
  • No signs of intra-abdominal abscess/phlegmon

Who cannot join

  • Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system).
  • Scoring system: As scoring system was developed determining the risk of complex appendicitis based upon five pre-operative variable. Points have been awarded to each variable. In case the total score is less than 4 points, the patient is likely to have a simple appendicitis. In case the score is 4 or more points, the chance of having complex appendicitis is significant and those children will be excluded from this study. Variables:
  • Diffuse abdominal guarding (3 points)
  • C-Reactive Protein level more than 38 mg/L (2 points)
  • Signs on ultrasound indicative of complex appendicitis (2 points)
  • More than one day abdominal pain (2 points)
Show all 12Show fewer
  • Temperature: more than 37.5 degree Celsius (1 point)
  • Faecolith (ultrasound)
  • Serious co-morbidity
  • Recurrent appendicitis
  • Suspicion of an underlying malignancy or inflammatory bowel disease
  • Documented type 1 allergy to the antibiotics used.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Netherlands15 sites

  • Medical Center Alkmaar

    Alkmaar

  • Flevoziekenhuis

    Almere Stad

  • Amstelland

    Amstelveen

  • AMC

    Amsterdam

  • OLVG

    Amsterdam

  • VU University medical center

    Amsterdam

  • Gelre Hospital

    Apeldoorn

  • Rijnstate

    Arnhem

  • Red Cross Hospital

    Beverwijk

  • Albert Schweitzer

    Dordrecht

  • Maxima medical center

    Eindhoven

  • Zuyderland

    Heerlen

  • Antonius Hospital

    Nieuwegein

  • Franciscus, Gasthuis en Vlietland

    Rotterdam

  • Haga ziekenhuis

    The Hague

Other trials in Netherlands

About this study

Official title: Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children Aged 7-17 Years Old - Antibiotics Versus Primary Appendectomy in Children With Simple Appendicitis: APAC Study

OBJECTIVE

The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications, health-related QOL and costs.

Main research question: What is the difference in proportion of patients experiencing complications within 1 year between both strategies in children from 7 to 17 years old, inclusive, with acute simple appendicitis?

Read the detailed description

Initial non-operative treatment of acute simple appendicitis has recently been investigated in both the adult as the paediatric population. In the adult population, six Randomised Controlled Trial (RCTs) showed that an appendectomy could be avoided in 40-76% of the patients at the end of their follow-up period. Despite the fact that some patients need to undergo a delayed appendectomy, it has been demonstrated in systematic reviews that non-operative treatment strategy is associated with a significant reduction in complications, faster recovery and return to work, less pain duration and analgesic medication consumption. In children only pilot data is yet available. Short-term success rates of this strategy (including of the investigators own pilot cohort study) are between the 83-92%. Long-term results (one-year follow-up) are available from two studies; 62-75% did not require an appendectomy. No large RCT have yet been conducted in the paediatric population. It is therefore essential to generate high quality empirical evidence regarding this strategy in this subset of patients.

Conditions
Appendicitis
Being tested
Augmentin + Gentamicin, Appendectomy
Keywords
Appendicitis, Appendectomy, Antibiotics
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmentin + GentamicinDrug

    Also called Amoxicillin/clavulanic acid (Augmentin) + Gentamicin

    Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours

  • AppendectomyProcedure or surgery

    Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics

Study groups in NCT02848820
Study groupRoleWhat they receive
Augmentin + GentamicinExperimentalInitial non-operative treatment strategy reserving an appendectomy for those not responding or with recurrent disease. It consist of: Clinical observation for 48 hours with administration of Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) and gentamicin 7mg/kg once daily for 48 hours. If after 48 hours the patient fulfils the predefined discharge criteria, the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days and discharge. An appendectomy is reserved for those patients with clinical deterioration, non-improvement after 72 hours or recurrent appendicitis. Pain medication according to national protocol.
Receives: Drug: Augmentin + Gentamicin
Operative treatment strategyActive comparatorClinical observation and semi-urgent appendectomy. Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics. Discharge if the patient fulfils the predefined discharge criteria. Pain medication according to national protocol.
Receives: Procedure: Appendectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients experiencing complications

    Measured: One year follow up

Secondary outcomes (16)

  1. Number of days absent from school, social or sport events

    Measured: 7 days, 1,6,12 months

  2. Number of days absent from work

    Measured: 7 days, 1,6,12 months

  3. Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain.

    Measured: 7 days, 1,6,12 months

  4. Total length of hospital stay during the follow-up period for strategy related treatment or complications

    Measured: 7 days, 1,6,12 months

  5. Total days of analgesics medication use.

    Measured: one month

  6. Pain score measured by the Visual Analogue Scale (VAS)

    Measured: Clinical phase (up to 7 days)

  7. Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis

    Measured: 7 days, 1,6,12 months

  8. Proportion of patients not having to undergone appendectomy

    Measured: 7 days, 1,6,12 months

  9. Proportion of patients experiencing recurrent appendicitis

    Measured: 7 days, 1,6,12 months

  10. Proportion of patients experiencing early failure of initial non-operative treatment.

    Measured: 7 days, 1,6,12 months

  11. Proportion of patients that undergo interval appendectomy.

    Measured: 7 days, 1,6,12 months

  12. Quality of life questionnaire (CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy)

    Measured: 7 days, 1,6,12 months

  13. Medical and non-medical costs (Health and Labor questionnaire)

    Measured: 1,6,12 months

  14. Quality adjusted life years (QALY's). Calculating using outcome 13 and 14

    Measured: 1,6,12 months

  15. Patient satisfaction questionnaire (PSQ-18 & Net promotor score)

    Measured: 7 days, 1,6,12 months

  16. Promoting and obstructing factors of implementability measured by questionnaires

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02848820
Sponsor's protocol ID
APAC2016
Acronym
APAC
Status last verified
Oct 2023
First submitted
24 Jul 2016
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Will follow

Publications

  • van Amstel P, Bachiri S, Knaapen M, van der Lee JH, van Eekelen R, Bemelman WA, Rippen-Wagner H, Bijlsma TS, Blanken-Peeters CFJM, Boerma EG, van den Boom AL, van den Broek FJC, Cense HA, van Duijvendijk P, Garssen FP, In 't Hof KH, Leijdekkers VJ, Lijkwan MA, Zijp GW, Heij HA, Derikx JPM, van Heurn ELW, Bakx R, Gorter RR; APAC collaborative study group. Non-operative treatment strategy versus surgery for children with simple appendicitis: non-inferiority randomised controlled trial. BMJ Med. 2026 May 13;5(1):e002466. doi: 10.1136/bmjmed-2025-002466. eCollection 2026.

    PubMed 42157906

  • Knaapen M, van der Lee JH, Bakx R, The SL, van Heurn EWE, Heij HA, Gorter RR; APAC collaborative study group. Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial). BMJ Open. 2017 Nov 15;7(11):e018145. doi: 10.1136/bmjopen-2017-018145.

    PubMed 29146647

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Augmentin + Gentamicin and Appendectomy in people with Appendicitis, run by Ramon Gorter at 15 sites in Netherlands.

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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Netherlands. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Proportion of patients experiencing complications (time frame: One year follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02848820, which also lists 2 linked publications.

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 23 Oct 2023.

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