Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

Overview

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.

Full Title of Study: “Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy – Randomized Non-inferiority Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

Interventions

  • Drug: Antibiotics, cefuroxime and metronidazole
    • Patient receives antibiotics while waiting appendectomy
  • Drug: No antibiotics
    • No antibiotics are given while waiting surgery.
  • Other: urgent schedule
    • Patients can wait up to 8 hours for surgery.
  • Other: less urgent schedule
    • Patients can wait up to 24 hours for surgery.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Complicated appendicitis
    • Time Frame: during surgery
    • Surgical finding is complicated appendicitis (AAST Grade III-V)

Secondary Measures

  • Time of hospital stay
    • Time Frame: 30 days from surgery
    • Time in hours from randomization to discharge from hospital
  • Postoperative complications
    • Time Frame: 30 days from surgery
    • complications are defined according to Clavien-Dindo classification
  • 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.
  • 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.
  • 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.
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Panu Mentula, Adjunct Professor – Helsinki University Central Hospital
  • Overall Official(s)
    • Panu J Mentula, MD, Principal Investigator, Helsinki University Central Hospital
  • Overall Contact(s)
    • Panu J Mentula, MD, +35894711, panu.mentula@hus.fi

References

Sammalkorpi HE, Mentula P, Leppäniemi 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.

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.

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.

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