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NCT Number: NCT06927765

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

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.

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Key information

Conditions

Perforated Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

No abdominal drain is placed

Other

No abdominal drain is placed

Primary outcomes

  1. Incision infection rate

    Time frame: 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

  2. Incidence of intra-abdominal abscess

    Time frame: 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

  3. Incidence of fecal leakage

    Time frame: From enrollment to 30 days postoperatively

    Dehiscence of the stump of the appendix causes fecal residue to enter the abdominal cavity

Secondary outcomes

  1. Length of hospital stay

    Time frame: From enrollment to 30 days postoperatively

    Length of hospital stay（days，d）

  2. Pain scores

    Time frame: From enrollment to 30 days postoperatively

    Visual Analog Score for pain

  3. Quality of life scores

    Time frame: From enrollment to 30 days postoperatively

    The MOS item short from health survey, SF-36

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

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

Acronym: LADPA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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