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Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis

Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis: A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06927765
Acronym
LADPA
Enrollment
500
Registered
2025-04-15
Start date
2024-06-01
Completion date
2025-05-31
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perforated Appendicitis

Keywords

Perforated appendicitis, abdominal drainage

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.

Interventions

OTHERNo abdominal drain is placed

No abdominal drain is placed

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
Incision infection rateFrom enrollment to 30 days postoperativelySuperficial 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 abscessFrom enrollment to 30 days postoperativelyResidual 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 leakageFrom enrollment to 30 days postoperativelyDehiscence of the stump of the appendix causes fecal residue to enter the abdominal cavity

Secondary

MeasureTime frameDescription
Length of hospital stayFrom enrollment to 30 days postoperativelyLength of hospital stay(days,d)
Pain scoresFrom enrollment to 30 days postoperativelyVisual Analog Score for pain
Quality of life scoresFrom enrollment to 30 days postoperativelyThe MOS item short from health survey, SF-36

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026