Clinical trial NCT04378868: Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy
Official title: Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Complicated appendicitis
timeFrame: during surgery
Secondary outcomes:
measure: Time of hospital stay
timeFrame: 30 days from surgery
measure: Postoperative complications
timeFrame: 30 days from surgery
measure: Pain measured by numeric rating scale while waiting surgery
timeFrame: up to 36 hours
measure: Surgical site infections (SSI) and positive blood cultures
timeFrame: within 30 days from randomization
measure: Conversions of laparoscopic surgeries to open surgery
timeFrame: during the the first operation for acute appendicitis
measure: Gangrenous or perforated appendicitis according to pathological examination.
timeFrame: 3 week after surgery
measure: Sunshine Appendicitis Grading System Score classification
timeFrame: during surgery
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: HUS, Jorvi Hospital
city: Helsinki
country: Finland
facility: HUS, Meilahti Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Panu J Mentula, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sammalkorpi HE, Mentula P, Leppaniemi 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.
citation: 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.
citation: 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.
citation: Jalava K, Sallinen V, Lampela H, Malmi H, Leppaniemi A, Mentula P. Role of delay and antibiotics on PERForation rate while waiting appendicECTomy (PERFECT): a protocol for a randomized non-inferiority trial. BJS Open. 2021 Sep 6;5(5):zrab089. doi: 10.1093/bjsopen/zrab089.