Acute Complicated Appendicitis With Peri-appendiceal Abscess or PhlegmonNCT06490185
Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients
An observational study of Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon, run by Shanghai Zhongshan Hospital.
Trial summary
This study aim to analyze the clinical data of patients who underwent emergency appendectomy for acute complicated appendicitis with peri-appendiceal abscess or phlegmon, identify factors influencing the post-operative length of hospital stay (LOS), and improve treatment strategies. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon
- What is being tested?
- Clinical data collection
- How many people
- 150 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
- Adult, Older adult
Study population: Acute complicated appendicitis patients with peri-appendiceal abscess or phlegmon who met the criteria.
Who may be able to join
- Patients who were aged ≥18 years, Patients who were clinically diagnosed with acute appendicitis, Patients who had a peri-appendiceal abscess or phlegmon on CT scan, Patients who opted to undergo immediate emergency surgery as their primary choice, Patients who refused conservative treatment first (antibiotic therapy and ultrasound/CT-guided drainage).
Who cannot join
- Patients younger than 18 years, Patients have a history of prior malignancies, Patients with diffuse peritonitis, Patients with incomplete clinical or pathological records.
About this study
Official title: Clinical Significance of Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients Undergoing Emergency Appendectomy: A Single-center Retrospective Study
This study aim to analyze the clinical data of patients who underwent emergency appendectomy for acute complicated appendicitis with peri-appendiceal abscess or phlegmon, identify factors influencing the post-operative length of hospital stay (LOS), and improve treatment strategies.
Read the detailed description
Appendicitis is defined as inflammation of the vermiform appendix and worldwide is the most common reason for emergency abdominal surgery. Globally, the annual incidence is 96.5 to 100 cases per 100 000 adult population. For acute uncomplicated appendicitis, antibiotic therapy has emerged as the primary treatment, often allowing patients to avoid surgery. However, the management of acute complicated appendicitis requires careful consideration of various treatment options.
Complicated appendicitis, characterized by peri-appendiceal phlegmon or abscess formation, presents additional challenges and often requires a more comprehensive treatment approach. Management strategies have evolved to incorporate both conservative and surgical treatments, tailored to the patient's condition. Typically, for early-stage appendicitis (duration of symptoms ≤72 hours) with peri-appendiceal phlegmon, surgical treatment is recommended, while late-stage appendicitis (duration of symptoms >72 hours) or cases with peri-appendiceal abscess formation are initially managed conservatively with percutaneous drainage and antibiotics. Despite this, some patients still prefer surgical intervention for various reasons. Currently, there is a lack of studies on the outcomes of patients with acute complicated appendicitis who opt for surgery over conservative treatment, highlighting the need for further research.
In practical terms, the benefits and risks of all treatment options should be thoroughly presented and discussed. Recommendations for surgery versus a conservative treatment-first approach should be based on individual clinical and radiographic findings, as well as patient treatment expectations and preferences. This study aim to investigate the clinical significance of peri-appendiceal abscess or phlegmon in the surgical management of acute complicated appendicitis.
- Being tested
- Clinical data collection
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
Clinical significance of peri-appendiceal abscess and phlegmon in acute complicated appendicitis patients undergoing emergency appendectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
The post-operative length of hospital stay (LOS)
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 posted8 Jul 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 Peri-appendiceal Abscess or PhlegmonStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 150 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
- NCT06490185
- Sponsor's protocol ID
- Zhongshan-HHY-06
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients Undergoing Emergency Appendectomy: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06490185
- Acronym / sponsor ID
- Zhongshan-HHY-06
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 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
- 8 Jul 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.
This study aim to analyze the clinical data of patients who underwent emergency appendectomy for acute complicated appendicitis with peri-appendiceal abscess or phlegmon, identify factors influencing the post-operative length of hospital stay (LOS), and improve treatment strategies.
Detailed description
Appendicitis is defined as inflammation of the vermiform appendix and worldwide is the most common reason for emergency abdominal surgery. Globally, the annual incidence is 96.5 to 100 cases per 100 000 adult population. For acute uncomplicated appendicitis, antibiotic therapy has emerged as the primary treatment, often allowing patients to avoid surgery. However, the management of acute complicated appendicitis requires careful consideration of various treatment options.
Complicated appendicitis, characterized by peri-appendiceal phlegmon or abscess formation, presents additional challenges and often requires a more comprehensive treatment approach. Management strategies have evolved to incorporate both conservative and surgical treatments, tailored to the patient's condition. Typically, for early-stage appendicitis (duration of symptoms ≤72 hours) with peri-appendiceal phlegmon, surgical treatment is recommended, while late-stage appendicitis (duration of symptoms >72 hours) or cases with peri-appendiceal abscess formation are initially managed conservatively with percutaneous drainage and antibiotics. Despite this, some patients still prefer surgical intervention for various reasons. Currently, there is a lack of studies on the outcomes of patients with acute complicated appendicitis who opt for surgery over conservative treatment, highlighting the need for further research.
In practical terms, the benefits and risks of all treatment options should be thoroughly presented and discussed. Recommendations for surgery versus a conservative treatment-first approach should be based on individual clinical and radiographic findings, as well as patient treatment expectations and preferences. This study aim to investigate the clinical significance of peri-appendiceal abscess or phlegmon in the surgical management of acute complicated appendicitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute complicated appendicitis patients with peri-appendiceal abscess or phlegmon who met the criteria.
Key inclusion criteria (1 listed)
- Patients who were aged ≥18 years, Patients who were clinically diagnosed with acute appendicitis, Patients who had a peri-appendiceal abscess or phlegmon on CT scan, Patients who opted to undergo immediate emergency surgery as their primary choice, Patients who refused conservative treatment first (antibiotic therapy and ultrasound/CT-guided drainage).
Key exclusion criteria (1 listed)
- Patients younger than 18 years, Patients have a history of prior malignancies, Patients with diffuse peritonitis, Patients with incomplete clinical or pathological records.
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 collectionClinical significance of peri-appendiceal abscess and phlegmon in acute complicated appendicitis patients undergoing emergency appendectomy | Other | – |
Primary outcome
The post-operative length of hospital stay (LOS)
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 8 Jul 2024.
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 Peri-appendiceal Abscess or Phlegmon, 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 8 Jul 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 post-operative length of hospital stay (LOS) (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 8 Jul 2024.