Back to resultsProtocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
Primary Purpose
Appendicitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Abdominal imaging
Score based selective abdominal imaging
Score based selective observation combined with selective abdominal imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Appendicitis
Eligibility Criteria
Inclusion Criteria: - Suspicion of appendicitis Exclusion Criteria: Time from symptom onset over 72 hours Age <18 years Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women CT-scan or ultrasound already done within the last 3 days (72 hours) Clinical suspicion of other disease or other reason to perform imaging study Recruited earlier to the same trial
Sites / Locations
- HUS, Jorvi Hospital
- HUS, Meilahti Hospital
- HUS, Hyvinkää Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Routine imaging
Adult Appendicitis Score based selective imaging
Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score
Arm Description
Patients will have first abdominal ultrasound, and if findings are negative or inconclusive for appendicitis abdominal CT scan is made. If ultrasound is not available, CT scan can be the first imaging study. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Other patients are discharged or treated according to possible alternative diagnosis.
Adult Appendicitis Score (AAS) is calculated as soon as possible. Patients with AAS 16 or higher are scheduled for urgent laparoscopic appendectomy. Patients with AAS 11- 15 will have abdominal imaging as in the group 1. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Patients with AAS 10 or less are discharged without imaging studies.
Patients with Adult Appendicitis Score (AAS) 10 or less are discharged without imaging studies. Patients with AAS 11 or more are managed based on Appendicitis Severity Score (ASS). ASS is used to identify patients with low risk of complicated disease. Patients with high ASS (>4) are managed as patients in arm 2. Patients with low ASS (<=4) begin observation protocol where patients can leave hospital and they are re-evaluated with repeated scoring after 12-24 hours from randomization. After re-scoring patients may be discharged if AAS is below 16 and decreasing and ASS is below 5 or if AAS is below 11. If AAS is 16 or higher or increasing, patients are scheduled for urgent laparoscopic appendectomy. After observation period, patients with decreasing AAS between 11-15 and ASS higher than 4 or patients with stable AAS between 11-15 are send for imaging study.
Outcomes
Primary Outcome Measures
Negative appendectomy
Number of negative appendectomies (surgical removal of non-inflamed appendix)
Complicated appendicitis
Number of patients with complicated appendicitis (AAST grade 3 or higher)
Secondary Outcome Measures
histologically proven appendicitis
Number of patients with histologically proven appendicitis undergoing surgery
CT scan
Number of patients having abdominal computed tomography
Adverse events
Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)
Appendicitis
Number of patients diagnosed with appendicitis
Quality of life (EQ-5D-5L index value)
Quality of life determined by weekly EQ-5D-5L index values.
Quality of life (EQ-5D-5L EQ-VAS score)
Quality of life determined by weekly EQ-5D-5L EQ-VAS score.
Costs in Euros
Overall costs of diagnostics and treatment
Full Information
NCT ID
NCT06083064
First Posted
October 5, 2023
Last Updated
October 11, 2023
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06083064
Brief Title
Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis
Acronym
PROSECCO
Official Title
Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 6, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
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
The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question[s] it aims to answer are:
Does protocol based selective imaging using clinical scoring affect clinical outcome?
Does protocol based selective observation combined with score based selective imaging affect clinical outcome?
Participants will be randomized into three groups:
Selective imaging based on Adult Appendicitis Score
Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score
Routine imaging using ultrasound and/or computed tomography
Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine imaging
Arm Type
Active Comparator
Arm Description
Patients will have first abdominal ultrasound, and if findings are negative or inconclusive for appendicitis abdominal CT scan is made. If ultrasound is not available, CT scan can be the first imaging study. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Other patients are discharged or treated according to possible alternative diagnosis.
Arm Title
Adult Appendicitis Score based selective imaging
Arm Type
Experimental
Arm Description
Adult Appendicitis Score (AAS) is calculated as soon as possible. Patients with AAS 16 or higher are scheduled for urgent laparoscopic appendectomy. Patients with AAS 11- 15 will have abdominal imaging as in the group 1. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Patients with AAS 10 or less are discharged without imaging studies.
Arm Title
Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score
Arm Type
Experimental
Arm Description
Patients with Adult Appendicitis Score (AAS) 10 or less are discharged without imaging studies. Patients with AAS 11 or more are managed based on Appendicitis Severity Score (ASS). ASS is used to identify patients with low risk of complicated disease. Patients with high ASS (>4) are managed as patients in arm 2. Patients with low ASS (<=4) begin observation protocol where patients can leave hospital and they are re-evaluated with repeated scoring after 12-24 hours from randomization. After re-scoring patients may be discharged if AAS is below 16 and decreasing and ASS is below 5 or if AAS is below 11. If AAS is 16 or higher or increasing, patients are scheduled for urgent laparoscopic appendectomy. After observation period, patients with decreasing AAS between 11-15 and ASS higher than 4 or patients with stable AAS between 11-15 are send for imaging study.
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal imaging
Intervention Description
Abdominal ultrasound and/or abdominal CT
Intervention Type
Other
Intervention Name(s)
Score based selective abdominal imaging
Intervention Description
Abdominal imaging is done selectively based on Adult Appendicitis Score
Intervention Type
Other
Intervention Name(s)
Score based selective observation combined with selective abdominal imaging
Intervention Description
Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging
Primary Outcome Measure Information:
Title
Negative appendectomy
Description
Number of negative appendectomies (surgical removal of non-inflamed appendix)
Time Frame
Within 30 days from randomization
Title
Complicated appendicitis
Description
Number of patients with complicated appendicitis (AAST grade 3 or higher)
Time Frame
Within 30 days from randomization
Secondary Outcome Measure Information:
Title
histologically proven appendicitis
Description
Number of patients with histologically proven appendicitis undergoing surgery
Time Frame
Within 30 days from randomization
Title
CT scan
Description
Number of patients having abdominal computed tomography
Time Frame
Within 30 days from randomization
Title
Adverse events
Description
Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)
Time Frame
Within one year from randomization
Title
Appendicitis
Description
Number of patients diagnosed with appendicitis
Time Frame
Within 2 years from randomization
Title
Quality of life (EQ-5D-5L index value)
Description
Quality of life determined by weekly EQ-5D-5L index values.
Time Frame
During the first 30 days from randomization
Title
Quality of life (EQ-5D-5L EQ-VAS score)
Description
Quality of life determined by weekly EQ-5D-5L EQ-VAS score.
Time Frame
During the first 30 days from randomization
Title
Costs in Euros
Description
Overall costs of diagnostics and treatment
Time Frame
During the first 30 days from randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Suspicion of appendicitis
Exclusion Criteria:
Time from symptom onset over 72 hours
Age <18 years
Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women
CT-scan or ultrasound already done within the last 3 days (72 hours)
Clinical suspicion of other disease or other reason to perform imaging study
Recruited earlier to the same trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panu Mentula, MD
Phone
504270183
Ext
+358
Email
panu.mentula@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panu 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 Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Lampela, MD
Facility Name
HUS, Meilahti Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panu J Mentula, MD
First Name & Middle Initial & Last Name & Degree
Panu Mentula, MD
First Name & Middle Initial & Last Name & Degree
Ville Sallinen, MD
First Name & Middle Initial & Last Name & Degree
Kirsi Lastunen, MD
Facility Name
HUS, Hyvinkää Hospital
City
Hyvinkää
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taina Nykänen, MD
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
35482016
Citation
Lastunen KS, Leppaniemi AK, Mentula PJ. DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial. Br J Surg. 2022 Jun 14;109(7):588-594. doi: 10.1093/bjs/znac120.
Results Reference
background
PubMed Identifier
25963411
Citation
Atema JJ, van Rossem CC, Leeuwenburgh MM, Stoker J, Boermeester MA. Scoring system to distinguish uncomplicated from complicated acute appendicitis. Br J Surg. 2015 Jul;102(8):979-90. doi: 10.1002/bjs.9835. Epub 2015 May 12.
Results Reference
background
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Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis
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