Colorectal CancerNCT06869096
Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery
A study testing Intraoperative area irrigation in people with Colorectal Cancer and Surgical Site Infection, run by Nanchong Central Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Surgical Site Infection, Chlorhexidine
- What is being tested?
- Intraoperative area irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Yunhong Tian, PHD 13508087719, drtianyunhong@126.com
About this study
Official title: A Comparative Study of Chlorhexidine Versus Saline Irrigation of the Surgical Area During Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled 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.
- Being tested
- Intraoperative area irrigation
- Medical subject headings
- Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative area irrigationProcedure or surgery
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 field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic rectal cancer patients, chlorhexidine irrigation group | Experimental | After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. Receives: Procedure: Intraoperative area irrigation |
| Diabetic rectal cancer patients, saline irrigation group | No intervention | Not described |
| Diabetic colon cancer patients, chlorhexidine irrigation group | Experimental | Not described Receives: Procedure: Intraoperative area irrigation |
| Diabetic colon cancer patients, saline irrigation group | No intervention | Not described |
| Non-diabetic rectal cancer patients, chlorhexidine irrigation group | Experimental | Not described Receives: Procedure: Intraoperative area irrigation |
| Non-diabetic rectal cancer patients, saline irrigation group | No intervention | Not described |
| Non-diabetic colon cancer patients, chlorhexidine irrigation group | Experimental | Not described Receives: Procedure: Intraoperative area irrigation |
| Non-diabetic colon cancer patients, saline irrigation group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Number of participants with Postoperative complication within 30 days
Including anastomotic fistula, anastomotic hemorrhage, intestinal obstruction, deep vein thrombosis and so on
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start2 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869096
- Sponsor's protocol ID
- 2024135
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Chlorhexidine Versus Saline Irrigation of the Surgical Area During Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06869096
- Acronym / sponsor ID
- 2024135
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Diabetic rectal cancer patients, chlorhexidine irrigation group | Experimental | Procedure: Intraoperative area irrigationAfter colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. |
| Diabetic rectal cancer patients, saline irrigation group | No intervention | – |
| Diabetic colon cancer patients, chlorhexidine irrigation group | Experimental | Procedure: Intraoperative area irrigation |
| Diabetic colon cancer patients, saline irrigation group | No intervention | – |
| Non-diabetic rectal cancer patients, chlorhexidine irrigation group | Experimental | Procedure: Intraoperative area irrigation |
| Non-diabetic rectal cancer patients, saline irrigation group | No intervention | – |
| Non-diabetic colon cancer patients, chlorhexidine irrigation group | Experimental | Procedure: Intraoperative area irrigation |
| Non-diabetic colon cancer patients, saline irrigation group | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative area irrigationAfter 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. | Procedure or surgery | Diabetic colon cancer patients, chlorhexidine irrigation group, Diabetic rectal cancer patients, chlorhexidine irrigation group, Non-diabetic colon cancer patients, chlorhexidine irrigation group, Non-diabetic rectal cancer patients, chlorhexidine irrigation group |
Primary outcome
Number of participants with Surgical site infection within 30 days
Time frame: 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.
1 secondary outcome
Number of participants with Postoperative complication within 30 days
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative area irrigation in people with Colorectal Cancer and Surgical Site Infection, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Surgical site infection within 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.