Clinical trial NCT06927765: Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Perforated Appendicitis
Keywords: Perforated appendicitis
abdominal drainage
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute perforated appendicitis \>18 years of age

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.).

Primary outcomes:
measure: Incision infection rate
timeFrame: From enrollment to 30 days postoperatively
measure: Incidence of intra-abdominal abscess
timeFrame: From enrollment to 30 days postoperatively
measure: Incidence of fecal leakage
timeFrame: From enrollment to 30 days postoperatively
Secondary outcomes:
measure: Length of hospital stay
timeFrame: From enrollment to 30 days postoperatively
measure: Pain scores
timeFrame: From enrollment to 30 days postoperatively
measure: Quality of life scores
timeFrame: From enrollment to 30 days postoperatively
Other outcomes:
Locations:
city: Qingdao'
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: