PROSECCO: Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06083064
• Collaborator: (none)
• Enrollment: 900
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 61.8
• Patients Per Site: 300
• Patients Per Site Per Month: 4.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis	Diagnostic Test: Abdominal imaging; Other: Score based selective abdominal imaging; Other: Score based selective observation combined with selective abdominal imaging	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 900 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 1:1:11:1:1
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
• Anticipated Study Start Date: Nov 6, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Routine imaging 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.	Diagnostic Test: Abdominal imaging; Abdominal ultrasound and/or abdominal CT
Experimental: Adult Appendicitis Score based selective imaging 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.	Other: Score based selective abdominal imaging; Abdominal imaging is done selectively based on Adult Appendicitis Score
Experimental: Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score 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.	Other: Score based selective observation combined with selective abdominal imaging; Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging

Outcome Measures

Primary Outcome Measures

1. Negative appendectomy [Within 30 days from randomization]

   Number of negative appendectomies (surgical removal of non-inflamed appendix)

2. Complicated appendicitis [Within 30 days from randomization]

   Number of patients with complicated appendicitis (AAST grade 3 or higher)

Secondary Outcome Measures

1. histologically proven appendicitis [Within 30 days from randomization]

   Number of patients with histologically proven appendicitis undergoing surgery

2. CT scan [Within 30 days from randomization]

   Number of patients having abdominal computed tomography

3. Adverse events [Within one year from randomization]

   Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)

4. Appendicitis [Within 2 years from randomization]

   Number of patients diagnosed with appendicitis

5. Quality of life (EQ-5D-5L index value) [During the first 30 days from randomization]

   Quality of life determined by weekly EQ-5D-5L index values.

6. Quality of life (EQ-5D-5L EQ-VAS score) [During the first 30 days from randomization]

   Quality of life determined by weekly EQ-5D-5L EQ-VAS score.

7. Costs in Euros [During the first 30 days from randomization]

   Overall costs of diagnostics and treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HUS, Jorvi Hospital	Espoo		Finland
2	HUS, Meilahti Hospital	Helsinki		Finland	00029
3	HUS, Hyvinkää Hospital	Hyvinkää		Finland

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

• Principal Investigator: Panu Mentula, MD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Panu Mentula, M.D., Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT06083064
• Other Study ID Numbers: HUS/74/2023
• First Posted: Oct 13, 2023
• Last Update Posted: Oct 13, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Appendicitis

Study Results

No Results Posted as of Oct 13, 2023