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

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Appendicitis

Treatments: Other: less urgent schedule; Drug: Antibiotics, cefuroxime and metronidazole; Other: urgent schedule; Drug: No antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04378868

HUS-PERFECT

2019-002348-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 4 patient groups

Surgery within 8 hours, no antibiotics

Active Comparator group

Description:

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.

Treatment:

Other: urgent schedule

Drug: No antibiotics

Surgery within 24 hours, no antibiotics

Experimental group

Description:

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.

Treatment:

Drug: No antibiotics

Other: less urgent schedule

Surgery within 8 hours, antibiotics

Experimental group

Description:

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.

Treatment:

Drug: Antibiotics, cefuroxime and metronidazole

Other: urgent schedule

Surgery within 24 hours, antibiotics

Experimental group

Description:

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.

Treatment:

Drug: Antibiotics, cefuroxime and metronidazole

Other: less urgent schedule