Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2023-02-23

Brief Summary

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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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Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized into two arms according to urgency and simultaneously each patient is randomized into two arms according to antibiotic treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

No antibiotics

Intervention Type DRUG

No antibiotics are given while waiting surgery.

urgent schedule

Intervention Type OTHER

Patients can wait up to 8 hours for surgery.

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.

Group Type EXPERIMENTAL

No antibiotics

Intervention Type DRUG

No antibiotics are given while waiting surgery.

less urgent schedule

Intervention Type OTHER

Patients can wait up to 24 hours for surgery.

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.

Group Type EXPERIMENTAL

Antibiotics, cefuroxime and metronidazole

Intervention Type DRUG

Patient receives antibiotics while waiting appendectomy

urgent schedule

Intervention Type OTHER

Patients can wait up to 8 hours for surgery.

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.

Group Type EXPERIMENTAL

Antibiotics, cefuroxime and metronidazole

Intervention Type DRUG

Patient receives antibiotics while waiting appendectomy

less urgent schedule

Intervention Type OTHER

Patients can wait up to 24 hours for surgery.

Interventions

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Antibiotics, cefuroxime and metronidazole

Patient receives antibiotics while waiting appendectomy

Intervention Type DRUG

No antibiotics

No antibiotics are given while waiting surgery.

Intervention Type DRUG

urgent schedule

Patients can wait up to 8 hours for surgery.

Intervention Type OTHER

less urgent schedule

Patients can wait up to 24 hours for surgery.

Intervention Type OTHER

Eligibility Criteria

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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
* Missing written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No