Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

NCT04378868 | Completed Phase 4

• 2 other identifiers: HUS-PERFECT2019-002348-26
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 2

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.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Complicated appendicitis

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

  during surgery

Secondary Outcomes (7)

• Time of hospital stay

  30 days from surgery

• Postoperative complications

  30 days from surgery

• Pain measured by numeric rating scale while waiting surgery

  up to 36 hours

• Surgical site infections (SSI) and positive blood cultures

  within 30 days from randomization

• Conversions of laparoscopic surgeries to open surgery

  during the the first operation for acute appendicitis

Study Arms (4)

Surgery within 8 hours, no antibiotics

ACTIVE COMPARATOR

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.

Drug: No antibiotics; Other: urgent schedule

Surgery within 24 hours, no antibiotics

EXPERIMENTAL

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.

Drug: No antibiotics; Other: less urgent schedule

Surgery within 8 hours, antibiotics

EXPERIMENTAL

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.

Drug: Antibiotics, cefuroxime and metronidazole; Other: urgent schedule

Surgery within 24 hours, antibiotics

EXPERIMENTAL

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.

Drug: Antibiotics, cefuroxime and metronidazole; Other: less urgent schedule

Interventions

Antibiotics, cefuroxime and metronidazole DRUG

Patient receives antibiotics while waiting appendectomy

Surgery within 24 hours, antibiotics; Surgery within 8 hours, antibiotics

No antibiotics DRUG

No antibiotics are given while waiting surgery.

Surgery within 24 hours, no antibiotics; Surgery within 8 hours, no antibiotics

urgent schedule OTHER

Patients can wait up to 8 hours for surgery.

Surgery within 8 hours, antibiotics; Surgery within 8 hours, no antibiotics

less urgent schedule OTHER

Patients can wait up to 24 hours for surgery.

Surgery within 24 hours, antibiotics; Surgery within 24 hours, no antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

HUS, Jorvi Hospital

Espoo, Finland

Location

HUS, Meilahti Hospital

Helsinki, 00029, Finland

Location

Related Publications (5)

• 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.

  PMID: 24970111 BACKGROUND

• 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.

  PMID: 24553565 BACKGROUND

• 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.

  PMID: 26333132 BACKGROUND

• Jalava K, Sallinen V, Lampela H, Malmi H, Steinholt I, Augestad KM, Leppaniemi A, Mentula P. Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial. Lancet. 2023 Oct 28;402(10412):1552-1561. doi: 10.1016/S0140-6736(23)01311-9. Epub 2023 Sep 14.

  PMID: 37717589 DERIVED

• 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.

  PMID: 34580704 DERIVED

Related Links

• Link for calculation of Adult Appendicitis Score

MeSH Terms

Conditions

Appendicitis

Interventions

Anti-Bacterial Agents; Cefuroxime; Metronidazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Panu J Mentula, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

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

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 7, 2020
• Study Start: May 18, 2020
• Primary Completion: January 23, 2023
• Study Completion: February 23, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)