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

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Antibiotics, cefuroxime and metronidazole
No antibiotics
urgent schedule
less urgent schedule
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • HUS, Jorvi Hospital
  • HUS, Meilahti Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Surgery within 8 hours, no antibiotics

Surgery within 24 hours, no antibiotics

Surgery within 8 hours, antibiotics

Surgery within 24 hours, antibiotics

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time of hospital stay
Time in hours from randomization to discharge from hospital
Postoperative complications
complications are defined according to Clavien-Dindo classification
Pain measured by numeric rating scale while waiting surgery
Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain.
Surgical site infections (SSI) and positive blood cultures
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.
Conversions of laparoscopic surgeries to open surgery
All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation.
Gangrenous or perforated appendicitis according to pathological examination.
All specimens are sent to pathological examination and all pathological reports are reviewed
Sunshine Appendicitis Grading System Score classification
Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome

Full Information

First Posted
April 29, 2020
Last Updated
July 9, 2023
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04378868
Brief Title
Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy
Acronym
PERFECT
Official Title
Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized into two arms according to urgency and simultaneously each patient is randomized into two arms according to antibiotic treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery within 8 hours, no antibiotics
Arm Type
Active Comparator
Arm 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.
Arm Title
Surgery within 24 hours, no antibiotics
Arm Type
Experimental
Arm 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.
Arm Title
Surgery within 8 hours, antibiotics
Arm Type
Experimental
Arm 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.
Arm Title
Surgery within 24 hours, antibiotics
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Antibiotics, cefuroxime and metronidazole
Intervention Description
Patient receives antibiotics while waiting appendectomy
Intervention Type
Drug
Intervention Name(s)
No antibiotics
Intervention Description
No antibiotics are given while waiting surgery.
Intervention Type
Other
Intervention Name(s)
urgent schedule
Intervention Description
Patients can wait up to 8 hours for surgery.
Intervention Type
Other
Intervention Name(s)
less urgent schedule
Intervention Description
Patients can wait up to 24 hours for surgery.
Primary Outcome Measure Information:
Title
Complicated appendicitis
Description
Surgical finding is complicated appendicitis (AAST Grade III-V)
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Time of hospital stay
Description
Time in hours from randomization to discharge from hospital
Time Frame
30 days from surgery
Title
Postoperative complications
Description
complications are defined according to Clavien-Dindo classification
Time Frame
30 days from surgery
Title
Pain measured by numeric rating scale while waiting surgery
Description
Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain.
Time Frame
up to 36 hours
Title
Surgical site infections (SSI) and positive blood cultures
Description
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.
Time Frame
within 30 days from randomization
Title
Conversions of laparoscopic surgeries to open surgery
Description
All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation.
Time Frame
during the the first operation for acute appendicitis
Title
Gangrenous or perforated appendicitis according to pathological examination.
Description
All specimens are sent to pathological examination and all pathological reports are reviewed
Time Frame
3 week after surgery
Title
Sunshine Appendicitis Grading System Score classification
Description
Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panu J Mentula, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUS, Jorvi Hospital
City
Espoo
Country
Finland
Facility Name
HUS, Meilahti Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24970111
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.
Results Reference
background
PubMed Identifier
24553565
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.
Results Reference
background
PubMed Identifier
26333132
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.
Results Reference
background
PubMed Identifier
34580704
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.
Results Reference
derived
Links:
URL
https://www.appendicitisscore.com
Description
Link for calculation of Adult Appendicitis Score

Learn more about this trial

Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

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