Perforated AppendicitisLADPANCT06927765
Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis
An observational study of Perforated Appendicitis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Acute appendicitis is the most common acute abdomen, and a small number of patients can progress to perforated appendicitis, which has significantly higher complications than non-perforated appendicitis. Appendectomy is the only option for treating perforated appendicitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- No abdominal drain is placed
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 May 2025
- How long will I take part?
- 30 Days
- 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: Patients with acute perforated appendicitis >18 years of age
Who may be able to join
- Age: ≥ 18 years old (no upper limit);
- Perforated appendicitis or suspected perforated appendicitis who intends to undergo laparoscopic appendectomy;
- Patients and their families (or legal representatives) are able to understand the study protocol and voluntarily participate in this study, and sign informed consent.
Who cannot join
- Whole abdominal pus was found during the operation;
- Open or laparoscopic conversion to open appendectomy;
- Appendiceal tumors (including postoperative pathology)
- Pregnancy or perinatal period;
- AIDS, tuberculosis, liver cirrhosis, uremia, aplastic anemia, essential thrombocytopenia, inflammatory bowel disease, organ transplantation;
- Long-term or preoperative use of immunosuppressants/glucocorticoids/tumor chemotherapy drugs/targeted drugs/immunodrugs;
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- Malignant tumors (including leukemia and lymphoma) disease status, recurrence/metastasis, and perioperative period;
- Drunk, drug abuse/drug addicts;
- Organ dysfunction/failure;
- Those who are transferred to the ICU for various reasons;
- Other conditions that the investigator considers unsuitable for inclusion (e.g., hyperthyroidism, bone marrow dysproliferative syndrome, acute myocardial infarction, acute cerebral infarction, diabetic ketoacidosis, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis: A Prospective, Multicenter, Randomized Controlled Trial
Acute appendicitis is the most common acute abdomen, and a small number of patients can progress to perforated appendicitis, which has significantly higher complications than non-perforated appendicitis. Appendectomy is the only option for treating perforated appendicitis. Optimizing the diagnosis and treatment of perforated appendicitis is of great significance to improve its clinical outcomes and save medical resources.
There is a consensus that drainage should not be placed after surgery for non-perforated appendicitis, but the decision to place drainage for perforated appendicitis remains controversial. Several retrospective studies have shown no benefit in postoperative recovery and hospital stay, and may lead to increased infectious complications and longer hospital stays. A small number of prospective studies have shown similar conclusions, but the sample size is too small, most of them are children, and there is a lack of large-scale multicenter studies. The investigators' preliminary retrospective survey suggests that in China, most surgeons still commonly place drains for peace of mind after surgery with perforated appendicitis in adults without seeing a clear benefit, so there is a need for a multicenter prospective randomized controlled study to evaluate the need for drainage placement after perforated appendicitis and to guide clinical practice with evidence.
To study the effect of abdominal drainage on the postoperative clinical outcomes of adult patients with perforated appendicitis, mainly including: infectious complications (residual infection or abscess in the abdominal cavity, incision infection, fecal fistula, etc.), case fatality rate, pain score, length of hospital stay (LOS), quality of life (QOL) score, etc.
- Conditions
- Perforated Appendicitis
- Being tested
- No abdominal drain is placed
- Keywords
- Perforated appendicitis, abdominal drainage
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No abdominal drain is placedOther
No abdominal drain is placed
| Study group | Role | What they receive |
|---|---|---|
| Place an abdominal drain | Place an abdominal drain Receives: Other: No abdominal drain is placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision infection rate
Superficial tissue infections, such as those at the site of the surgical Trocar foramen (epidermal or subcutaneous), do not enter the abdominal cavity
Measured: From enrollment to 30 days postoperatively
Incidence of intra-abdominal abscess
Residual infection in the abdominal cavity forms an abscess.The incidence of intra-abdominal abscess after surgery will be compared between the two groups
Measured: From enrollment to 30 days postoperatively
Incidence of fecal leakage
Dehiscence of the stump of the appendix causes fecal residue to enter the abdominal cavity
Measured: From enrollment to 30 days postoperatively
Secondary outcomes (3)
Length of hospital stay
Length of hospital stay（days，d）
Measured: From enrollment to 30 days postoperatively
Pain scores
Visual Analog Score for pain
Measured: From enrollment to 30 days postoperatively
Quality of life scores
The MOS item short from health survey, SF-36
Measured: From enrollment to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927765
- Sponsor's protocol ID
- LADPA
- Acronym
- LADPA
- Status last verified
- Apr 2025
- First submitted
- 23 Dec 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: secrecy
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06927765
- Acronym / sponsor ID
- LADPA / LADPA
- Conditions
- Perforated Appendicitis
- Keywords
- Perforated appendicitis, abdominal drainage
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 15 Apr 2025 (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.
Acute appendicitis is the most common acute abdomen, and a small number of patients can progress to perforated appendicitis, which has significantly higher complications than non-perforated appendicitis. Appendectomy is the only option for treating perforated appendicitis. Optimizing the diagnosis and treatment of perforated appendicitis is of great significance to improve its clinical outcomes and save medical resources.
There is a consensus that drainage should not be placed after surgery for non-perforated appendicitis, but the decision to place drainage for perforated appendicitis remains controversial. Several retrospective studies have shown no benefit in postoperative recovery and hospital stay, and may lead to increased infectious complications and longer hospital stays. A small number of prospective studies have shown similar conclusions, but the sample size is too small, most of them are children, and there is a lack of large-scale multicenter studies. The investigators' preliminary retrospective survey suggests that in China, most surgeons still commonly place drains for peace of mind after surgery with perforated appendicitis in adults without seeing a clear benefit, so there is a need for a multicenter prospective randomized controlled study to evaluate the need for drainage placement after perforated appendicitis and to guide clinical practice with evidence.
To study the effect of abdominal drainage on the postoperative clinical outcomes of adult patients with perforated appendicitis, mainly including: infectious complications (residual infection or abscess in the abdominal cavity, incision infection, fecal fistula, etc.), case fatality rate, pain score, length of hospital stay (LOS), quality of life (QOL) score, etc.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Place an abdominal drain | – | Other: No abdominal drain is placedPlace an abdominal drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute perforated appendicitis >18 years of age
Key inclusion criteria (3 listed)
- Age: ≥ 18 years old (no upper limit);
- Perforated appendicitis or suspected perforated appendicitis who intends to undergo laparoscopic appendectomy;
- Patients and their families (or legal representatives) are able to understand the study protocol and voluntarily participate in this study, and sign informed consent.
Key exclusion criteria (11 listed)
- Whole abdominal pus was found during the operation;
- Open or laparoscopic conversion to open appendectomy;
- Appendiceal tumors (including postoperative pathology)
- Pregnancy or perinatal period;
- AIDS, tuberculosis, liver cirrhosis, uremia, aplastic anemia, essential thrombocytopenia, inflammatory bowel disease, organ transplantation;
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 |
|---|---|---|
| No abdominal drain is placedNo abdominal drain is placed | Other | Place an abdominal drain |
Primary outcome
Incision infection rate
Time frame: From enrollment to 30 days postoperatively
Superficial tissue infections, such as those at the site of the surgical Trocar foramen (epidermal or subcutaneous), do not enter the abdominal cavity
Incidence of intra-abdominal abscess
Time frame: From enrollment to 30 days postoperatively
Residual infection in the abdominal cavity forms an abscess.The incidence of intra-abdominal abscess after surgery will be compared between the two groups
Incidence of fecal leakage
Time frame: From enrollment to 30 days postoperatively
Dehiscence of the stump of the appendix causes fecal residue to enter the abdominal cavity
3 secondary outcomes
Length of hospital stay
Time frame: From enrollment to 30 days postoperatively
Pain scores
Time frame: From enrollment to 30 days postoperatively
Quality of life scores
Time frame: From enrollment to 30 days postoperatively
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 15 Apr 2025.
- Individual participant dataSharing planned: No. secrecy
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perforated Appendicitis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incision infection rate (time frame: From enrollment to 30 days postoperatively). The study lists 3 primary outcomes in all. 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 15 Apr 2025.