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Recruiting NCT06869096

Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery

No phase Interventional Colorectal Cancer Surgical Site Infection Chlorhexidine Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoperative area irrigation.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Surgical Site Infection, Chlorhexidine, Complications. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study of Chlorhexidine Versus Saline Irrigation of the Surgical Area During Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.

Overview

The aim of this study was to compare the effectiveness of chlorhexidine versus saline in flushing the surgical area during colorectal cancer surgery. The primary outcomes included surgical site infection, postoperative complication rates, et al.

Interventions

  • Procedure Intraoperative area irrigation
    After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. According to abdominal cavity contamination, bleeding and tumor invasion to determine the flushing time and flush fluid volume. If the abdominal cavity infection is more serious or exudate more, the flushing time can be relatively prolonged. At last, there were no obvious blood residue, tissue fragments and suppurative secretions in abdominal cavity. Ensure that the surgical fi

Primary outcome measures

  • Number of participants with Surgical site infection within 30 days [Time frame: 30 days]
Secondary outcome measures (1)
  • Number of participants with Postoperative complication within 30 days [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Patients aged 18-85 years,
  • Patients with surgically resectable colorectal tumors confirmed by CT/MRI before surgery
  • All patients had a performance status score of 0 or 1 in the Eastern Tumor Cooperative group
  • American Society of Anesthesiology grade I-III

Exclusion criteria

  • The tumor may have distant metastasis
  • History of previous abdominal surgery
  • The patient has a history of other malignant tumors diagnosed in the past 5 years and has received radiotherapy and chemotherapy in the past
  • There are obvious contraindications to surgery (obvious abnormal liver and kidney function, pregnancy)
  • Participated in other clinical trials within the past 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Nanchong Central Hospital — Nanchong

Identifiers

NCT: NCT06869096 · 2024135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗