Acute Complicated Appendicitis With Diffuse PeritonitisNCT06633744
Laparoscopic Versus Open Appendectomy Plus Peritoneal Lavage for Acute Complicated Appendicitis Patients With Diffuse Peritonitis
An observational study of Acute Complicated Appendicitis With Diffuse Peritonitis, run by Shanghai Zhongshan Hospital.
Trial summary
This study aim to evaluate the efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Complicated Appendicitis With Diffuse Peritonitis
- How many people
- 60 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute complicated appendicitis patients with diffuse peritonitis who met the criteria.
Who may be able to join
- Patients aged 18 or older;
- Patients with diffuse peritonitis caused by a perforated appendix confirmed intraoperatively;
- Patients who underwent emergency appendectomy with peritoneal lavage;
- Patients who had postoperative pathological confirmation of acute appendicitis.
- -
Who cannot join
- Patients younger than 18 years;
- Patients have a history of prior malignancies;
- Patients with incomplete clinical or pathological records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Laparoscopic Versus Open Appendectomy Plus Peritoneal Lavage for Acute Complicated Appendicitis Patients With Diffuse Peritonitis: A Single-center Retrospective Study
This study aim to evaluate the efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis.
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. However, for Acute complicated appendicitis with diffuse peritonitis, surgery is the only option. Acute complicated appendicitis with diffuse peritonitis is a severe abdominal emergency that often requires prompt surgical intervention. Traditionally, open appendectomy has been the standard approach. In recent years, laparoscopic appendectomy has gained popularity due to its minimally invasive nature and potential for faster recovery. Despite this, the optimal surgical approach for complicated appendicitis with diffuse peritonitis remains debated, particularly regarding the risk of postoperative complications and recovery outcomes. The primary aim of this study is to compare the efficacy and safety of laparoscopic versus open appendectomy in such cases, focusing on postoperative complications, hospital stay, and other factors influencing surgical outcomes.
- Keywords
- Acute appendicitis, Laparoscopic appendectomy, Open appendectomy Peritoneal lavage, Diffuse peritonitis
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis
This involved analyzing the correlation between the surgical approach and the incidence of postoperative complications, particularly surgical site infections (SSI).
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 posted9 Oct 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 Diffuse PeritonitisStudies 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
- 60 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
- NCT06633744
- Sponsor's protocol ID
- Zhongshan-HHY-07
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Appendectomy Plus Peritoneal Lavage for Acute Complicated Appendicitis Patients With Diffuse Peritonitis: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06633744
- Acronym / sponsor ID
- Zhongshan-HHY-07
- Keywords
- Acute appendicitis, Laparoscopic appendectomy, Open appendectomy Peritoneal lavage, Diffuse peritonitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 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
- 9 Oct 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 evaluate the efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis.
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. However, for Acute complicated appendicitis with diffuse peritonitis, surgery is the only option. Acute complicated appendicitis with diffuse peritonitis is a severe abdominal emergency that often requires prompt surgical intervention. Traditionally, open appendectomy has been the standard approach. In recent years, laparoscopic appendectomy has gained popularity due to its minimally invasive nature and potential for faster recovery. Despite this, the optimal surgical approach for complicated appendicitis with diffuse peritonitis remains debated, particularly regarding the risk of postoperative complications and recovery outcomes. The primary aim of this study is to compare the efficacy and safety of laparoscopic versus open appendectomy in such cases, focusing on postoperative complications, hospital stay, and other factors influencing surgical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute complicated appendicitis patients with diffuse peritonitis who met the criteria.
Key inclusion criteria (5 listed)
- Patients aged 18 or older;
- Patients with diffuse peritonitis caused by a perforated appendix confirmed intraoperatively;
- Patients who underwent emergency appendectomy with peritoneal lavage;
- Patients who had postoperative pathological confirmation of acute appendicitis.
- -
Key exclusion criteria (3 listed)
- Patients younger than 18 years;
- Patients have a history of prior malignancies;
- 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.
Primary outcome
The efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis
Time frame: January 01, 2025 to December 31, 2025.
This involved analyzing the correlation between the surgical approach and the incidence of postoperative complications, particularly surgical site infections (SSI).
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 9 Oct 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Complicated Appendicitis With Diffuse Peritonitis, 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 5 inclusion and 3 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 9 Oct 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?
Contact HONGYONG HE, Doctor (86-17601383022, he.hongyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis (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 9 Oct 2024.