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

NCT ID: NCT06927765

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-31

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.

Conditions

Perforated Appendicitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Place an abdominal drain

Place an abdominal drain

No abdominal drain is placed

Intervention Type: OTHER

No abdominal drain is placed

Interventions

No abdominal drain is placed

No abdominal drain is placed

Intervention Type: OTHER

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

LADPA

Identifier Type: -

Identifier Source: org_study_id