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

NCT06927765 | Active Not Recruiting

• 1 other identifier: LADPA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

Perforated appendicitis; abdominal drainage

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  From enrollment to 30 days postoperatively

Secondary Outcomes (3)

• Length of hospital stay

  From enrollment to 30 days postoperatively

• Pain scores

  From enrollment to 30 days postoperatively

• Quality of life scores

  From enrollment to 30 days postoperatively

Study Arms (1)

Place an abdominal drain

Place an abdominal drain

Other: No abdominal drain is placed

Interventions

No abdominal drain is placed OTHER

No abdominal drain is placed

Place an abdominal drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute perforated appendicitis \>18 years of age

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excision of the appendix Intraperitoneal pus

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: April 15, 2025
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)