Acute Complicated Appendicitis With AbscessNCT06469086
Appendicoliths in Acute Complicated Appendicitis Patients With Abscess
An observational study of Acute Complicated Appendicitis With Abscess, run by Shanghai Zhongshan Hospital.
Trial summary
Complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Complicated Appendicitis With Abscess
- What is being tested?
- Clinical data collection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute complicated appendicitis patients with absces swho met the criteria.
Who may be able to join
- Patients who aged ≥18 years, who diagnosed as acute appendicitis clinically, who had peri-appendiceal abscess larger than 2 cm in diameter on CT scan, who agreed conservative treatment first, who refused immediate emergency surgery
Who cannot join
- Patients younger than 18 years, those with malignancies, those with incomplete clinical or pathological records were excluded from the study
About this study
Official title: Clinical Significance of Appendicoliths in Conservative Treatment of Acute Complicated Appendicitis Patients With Abscess: A Single-center Retrospective Study
Complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. Traditionally, the standard treatment for complicated appendicitis has been surgical intervention. However, conservative management, involving antibiotics and drainage, has emerged as a viable alternative for selected patients. Recent studies emphasize the importance of selecting appropriate antibiotics based on local resistance patterns and the patient's clinical condition. Broad-spectrum antibiotics, including those targeting anaerobic bacteria, are often preferred. In addition, advances in imaging technology, such as ultrasound-guided drainage, have improved the precision and success rates of percutaneous abscess drainage. This minimally invasive approach helps manage localized infections and can prevent the need for immediate surgery.
One factor that has gained significant attention in determining the success of conservative treatment for acute complicated appendicitis is the presence of appendicoliths-calcified deposits within the appendix. This study aims to investigate the clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.
- Being tested
- Clinical data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
The clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of conservative treatment
Measured: January 01, 2025 to December 31, 2025.
Secondary outcomes (3)
Postoperative complications
Measured: January 01, 2025 to December 31, 2025.
Length of postoperative hospital stay
Measured: January 01, 2025 to December 31, 2025.
The surgical approach used
Measured: January 01, 2025 to December 31, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Complicated Appendicitis With AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469086
- Sponsor's protocol ID
- Zhongshan-HHY-05
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Appendicoliths in Conservative Treatment of Acute Complicated Appendicitis Patients With Abscess: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06469086
- Acronym / sponsor ID
- Zhongshan-HHY-05
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. Traditionally, the standard treatment for complicated appendicitis has been surgical intervention. However, conservative management, involving antibiotics and drainage, has emerged as a viable alternative for selected patients. Recent studies emphasize the importance of selecting appropriate antibiotics based on local resistance patterns and the patient's clinical condition. Broad-spectrum antibiotics, including those targeting anaerobic bacteria, are often preferred. In addition, advances in imaging technology, such as ultrasound-guided drainage, have improved the precision and success rates of percutaneous abscess drainage. This minimally invasive approach helps manage localized infections and can prevent the need for immediate surgery.
One factor that has gained significant attention in determining the success of conservative treatment for acute complicated appendicitis is the presence of appendicoliths-calcified deposits within the appendix. This study aims to investigate the clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute complicated appendicitis patients with absces swho met the criteria.
Key inclusion criteria (1 listed)
- Patients who aged ≥18 years, who diagnosed as acute appendicitis clinically, who had peri-appendiceal abscess larger than 2 cm in diameter on CT scan, who agreed conservative treatment first, who refused immediate emergency surgery
Key exclusion criteria (1 listed)
- Patients younger than 18 years, those with malignancies, those with incomplete clinical or pathological records were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical data collectionThe clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses. | Other | – |
Primary outcome
The success rate of conservative treatment
Time frame: January 01, 2025 to December 31, 2025.
3 secondary outcomes
Postoperative complications
Time frame: January 01, 2025 to December 31, 2025.
Length of postoperative hospital stay
Time frame: January 01, 2025 to December 31, 2025.
The surgical approach used
Time frame: January 01, 2025 to December 31, 2025.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients
Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Complicated Appendicitis With Abscess, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of conservative treatment (time frame: January 01, 2025 to December 31, 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.