Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNanchong Central Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Intraoperative area irrigation
Procedure/SurgeryAfter 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 field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.
Treatment groups
532 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Diabetic rectal cancer patients, chlorhexidine irrigation groupExperimental treatment 1 intervention
Group B: Diabetic rectal cancer patients, saline irrigation groupNo intervention 0 interventions
Group C: Diabetic colon cancer patients, chlorhexidine irrigation groupExperimental treatment 1 intervention
Group D: Diabetic colon cancer patients, saline irrigation groupNo intervention 0 interventions
Group E: Non-diabetic rectal cancer patients, chlorhexidine irrigation groupExperimental treatment 1 intervention
Group F: Non-diabetic rectal cancer patients, saline irrigation groupNo intervention 0 interventions
Group G: Non-diabetic colon cancer patients, chlorhexidine irrigation groupExperimental treatment 1 intervention
Group H: Non-diabetic colon cancer patients, saline irrigation groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants with Surgical site infection within 30 days
Any surgical site infection within 30 days of surgery is classified as superficial incision, deep mouth, or organ space infection according to the U.S. Centers for Disease Control and Prevention standards.
Time frame
30 daysSecondary outcomes
1
Number of participants with Postoperative complication within 30 days
Including anastomotic fistula, anastomotic hemorrhage, intestinal obstruction, deep vein thrombosis and so on
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov