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

Active, not recruiting

• Conditions: Perforated Appendicitis

• Registration Number: NCT06927765
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-12-23
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incision infection rate	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	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	From enrollment to 30 days postoperatively	Dehiscence of the stump of the appendix causes fecal residue to enter the abdominal cavity

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	From enrollment to 30 days postoperatively	Length of hospital stay（days，d）
Pain scores	From enrollment to 30 days postoperatively	Visual Analog Score for pain
Quality of life scores	From enrollment to 30 days postoperatively	The MOS item short from health survey, SF-36

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao', Shandong, China