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Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy (PERFECT)

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ClinicalTrials.gov Identifier: NCT04378868
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Panu Mentula, Helsinki University Central Hospital

Brief 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. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: Antibiotics, cefuroxime and metronidazole Drug: No antibiotics Other: urgent schedule Other: less urgent schedule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgery within 8 hours, no antibiotics
Patients 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.
Drug: No antibiotics
No antibiotics are given while waiting surgery.

Other: urgent schedule
Patients can wait up to 8 hours for surgery.

Experimental: Surgery within 24 hours, no antibiotics
Patients 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.
Drug: No antibiotics
No antibiotics are given while waiting surgery.

Other: less urgent schedule
Patients can wait up to 24 hours for surgery.

Experimental: Surgery within 8 hours, antibiotics
Patients 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.
Drug: Antibiotics, cefuroxime and metronidazole
Patient receives antibiotics while waiting appendectomy

Other: urgent schedule
Patients can wait up to 8 hours for surgery.

Experimental: Surgery within 24 hours, antibiotics
Patients 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.
Drug: Antibiotics, cefuroxime and metronidazole
Patient receives antibiotics while waiting appendectomy

Other: less urgent schedule
Patients can wait up to 24 hours for surgery.




Primary Outcome Measures :
  1. Complicated appendicitis [ Time Frame: during surgery ]
    Surgical finding is complicated appendicitis (AAST Grade III-V)


Secondary Outcome Measures :
  1. Time of hospital stay [ Time Frame: 30 days from surgery ]
    Time in hours from randomization to discharge from hospital

  2. Postoperative complications [ Time Frame: 30 days from surgery ]
    complications are defined according to Clavien-Dindo classification

  3. Pain measured by numeric rating scale while waiting surgery [ Time Frame: up to 36 hours ]
    Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain.

  4. Surgical site infections (SSI) and positive blood cultures [ Time Frame: within 30 days from randomization ]
    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.

  5. Conversions of laparoscopic surgeries to open surgery [ Time Frame: during the the first operation for acute appendicitis ]
    All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation.

  6. Gangrenous or perforated appendicitis according to pathological examination. [ Time Frame: 3 week after surgery ]
    All specimens are sent to pathological examination and all pathological reports are reviewed

  7. Sunshine Appendicitis Grading System Score classification [ Time Frame: during surgery ]
    Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378868


Contacts
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Contact: Panu J Mentula, MD +35894711 panu.mentula@hus.fi

Locations
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Finland
HUS, Jorvi Hospital Recruiting
Espoo, Finland
Contact: Hanna Lampela, MD         
Principal Investigator: Hanna Lampela, MD         
Sub-Investigator: Hanna Malmi, MD         
HUS, Meilahti Hospital Recruiting
Helsinki, Finland, 00029
Contact: Panu J Mentula, MD         
Principal Investigator: Panu Mentula, MD         
Sub-Investigator: Karoliina Jalava, MD         
Sub-Investigator: Ari Leppäniemi, Prof         
Sub-Investigator: Ville Sallinen, MD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Panu J Mentula, MD Helsinki University Central Hospital
Additional Information:
Publications:
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Responsible Party: Panu Mentula, Adjunct Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04378868    
Other Study ID Numbers: HUS-PERFECT
2019-002348-26 ( EudraCT Number )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Metronidazole
Cefuroxime
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents