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NCT Number: NCT04378868

Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

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.

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Key information

Conditions

Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HUS, Jorvi Hospital, Espoo, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotics, cefuroxime and metronidazole

Drug

Patient receives antibiotics while waiting appendectomy

No antibiotics

Drug

No antibiotics are given while waiting surgery.

urgent schedule

Other

Patients can wait up to 8 hours for surgery.

less urgent schedule

Other

Patients can wait up to 24 hours for surgery.

Primary outcomes

  1. Complicated appendicitis

    Time frame: during surgery

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: PERFECT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 7, 2020
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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