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AppendicitisPhase 4PERFECTNCT04378868

Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

A Phase 4 study testing Antibiotics, cefuroxime and metronidazole, No antibiotics and urgent schedule in people with Appendicitis, run by Helsinki University Central Hospital at 2 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Appendicitis
What is being tested?
Antibiotics, cefuroxime and metronidazole, No antibiotics and urgent schedule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
2 sitesFinland
Study dates
18 May 2020to 23 Feb 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute appendicitis where surgery is planned. Diagnosis of appendicitis should be verified either by clinical diagnosis with Adult Appendicitis Score >=16 or by diagnostic imaging (CT-scan, MRI or ultrasound) showing appendicitis. All patients with symptoms at least 3 days should undergo diagnostic imaging before inclusion.

Who cannot join

  • Complicated appendicitis according to diagnostic imaging. The following findings indicate complicated appendicitis: extraluminal air or extraluminal fecalith; fluid collection, abscess or phlegmon next to appendix; non-enhancement appendiceal wall on contrast enhanced CT-scan.
  • Plasma C-reactive protein >=100
  • Fever measured on emergency department over 38.5 degrees Celcius.
  • Clinical generalized peritonitis or other reason that indicate immediate surgery
  • Pregnancy, pregnancy test is taken from all fertile aged women before randomization
  • Allergy to study antibiotics, or anaphylactic reaction after betalactam antibiotic or other contraindication for metronidazole or ongoing antibiotic treatment or patient is carrier of resistant bacteria. (This exclusion criteria are applicable only on randomization into antibiotic treatment arms)
  • Missing written informed consent

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • HUS, Jorvi Hospital

    Espoo

  • HUS, Meilahti Hospital

    Helsinki, 00029

Other trials in Finland

About this study

Official title: Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial

This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.

Conditions
Appendicitis
Being tested
Antibiotics, cefuroxime and metronidazole, No antibiotics, urgent schedule, less urgent schedule
Medical subject headings
Appendicitis

What participants receive

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

  • Antibiotics, cefuroxime and metronidazoleDrug

    Patient receives antibiotics while waiting appendectomy

  • No antibioticsDrug

    No antibiotics are given while waiting surgery.

  • urgent scheduleOther

    Patients can wait up to 8 hours for surgery.

  • less urgent scheduleOther

    Patients can wait up to 24 hours for surgery.

Study groups in NCT04378868
Study groupRoleWhat they receive
Surgery within 8 hours, no antibioticsActive comparatorPatients are planned for urgent operation, that should be done within 8 hours. Operation can be done during the night time. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.
Receives: Drug: No antibiotics; Other: urgent schedule
Surgery within 24 hours, no antibioticsExperimentalPatients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.
Receives: Drug: No antibiotics; Other: less urgent schedule
Surgery within 8 hours, antibioticsExperimentalPatients are planned for urgent operation, that should be done within 8 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.
Receives: Drug: Antibiotics, cefuroxime and metronidazole; Other: urgent schedule
Surgery within 24 hours, antibioticsExperimentalPatients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.
Receives: Drug: Antibiotics, cefuroxime and metronidazole; Other: less urgent schedule

What is being measured

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

  1. Complicated appendicitis

    Surgical finding is complicated appendicitis (AAST Grade III-V)

    Measured: during surgery

Secondary outcomes (7)

  1. Time of hospital stay

    Time in hours from randomization to discharge from hospital

    Measured: 30 days from surgery

  2. Postoperative complications

    complications are defined according to Clavien-Dindo classification

    Measured: 30 days from surgery

  3. Pain measured by numeric rating scale while waiting surgery

    Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain.

    Measured: up to 36 hours

  4. Surgical site infections (SSI) and positive blood cultures

    SSIs classified according to CDC classification: superficial incisional, deep incisional and organ/space infection. Blood cultures are obtained if patient has fever over 38.5 degrees Celcius.

    Measured: within 30 days from randomization

  5. Conversions of laparoscopic surgeries to open surgery

    All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation.

    Measured: during the the first operation for acute appendicitis

  6. Gangrenous or perforated appendicitis according to pathological examination.

    All specimens are sent to pathological examination and all pathological reports are reviewed

    Measured: 3 week after surgery

  7. Sunshine Appendicitis Grading System Score classification

    Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome

    Measured: during surgery

Timeline

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

  1. First posted7 May 2020
  2. Study start18 May 2020
  3. Primary completion23 Jan 2023
  4. Study completion23 Feb 2023

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
Model description
Patients are randomized into two arms according to urgency and simultaneously each patient is randomized into two arms according to antibiotic treatment
Masking
None (open label)
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378868
Sponsor's protocol ID
HUS-PERFECT
Other IDs
2019-002348-26, 2019
Acronym
PERFECT
Status last verified
Jul 2023
First submitted
29 Apr 2020
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114.

    PubMed 24970111

  • Shafi S, Aboutanos M, Brown CV, Ciesla D, Cohen MJ, Crandall ML, Inaba K, Miller PR, Mowery NT; American Association for the Surgery of Trauma Committee on Patient Assessment and Outcomes. Measuring anatomic severity of disease in emergency general surgery. J Trauma Acute Care Surg. 2014 Mar;76(3):884-7. doi: 10.1097/TA.0b013e3182aafdba.

    PubMed 24553565

  • Reid F, Choi J, Williams M, Chan S. Prospective evaluation of the Sunshine Appendicitis Grading System score. ANZ J Surg. 2017 May;87(5):368-371. doi: 10.1111/ans.13271. Epub 2015 Sep 1.

    PubMed 26333132

  • Jalava K, Sallinen V, Lampela H, Malmi H, Steinholt I, Augestad KM, Leppaniemi A, Mentula P. Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial. Lancet. 2023 Oct 28;402(10412):1552-1561. doi: 10.1016/S0140-6736(23)01311-9. Epub 2023 Sep 14.

    PubMed 37717589

  • Jalava K, Sallinen V, Lampela H, Malmi H, Leppaniemi A, Mentula P. Role of delay and antibiotics on PERForation rate while waiting appendicECTomy (PERFECT): a protocol for a randomized non-inferiority trial. BJS Open. 2021 Sep 6;5(5):zrab089. doi: 10.1093/bjsopen/zrab089.

    PubMed 34580704

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Antibiotics, cefuroxime and metronidazole, No antibiotics and urgent schedule in people with Appendicitis, run by Helsinki University Central Hospital at 2 sites in Finland.

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 1 inclusion and 7 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. 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?

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?

Complicated appendicitis (time frame: during surgery). 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 NCT04378868, which also lists 5 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 11 Jul 2023.

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