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

NCT ID: NCT06869096

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Surgical Site Infection Chlorhexidine Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Diabetic rectal cancer patients, chlorhexidine irrigation group

After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin.

Group Type EXPERIMENTAL

Intraoperative area irrigation

Intervention Type PROCEDURE

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.

Diabetic rectal cancer patients, saline irrigation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Diabetic colon cancer patients, chlorhexidine irrigation group

Group Type EXPERIMENTAL

Intraoperative area irrigation

Intervention Type PROCEDURE

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.

Diabetic colon cancer patients, saline irrigation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-diabetic rectal cancer patients, chlorhexidine irrigation group

Group Type EXPERIMENTAL

Intraoperative area irrigation

Intervention Type PROCEDURE

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.

Non-diabetic rectal cancer patients, saline irrigation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-diabetic colon cancer patients, chlorhexidine irrigation group

Group Type EXPERIMENTAL

Intraoperative area irrigation

Intervention Type PROCEDURE

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.

Non-diabetic colon cancer patients, saline irrigation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanchong Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanchong Central Hospital

Nanchong, Sichuan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yunhong Tian

Role: primary

PHD 13508087719

Other Identifiers

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2024135

Identifier Type: -

Identifier Source: org_study_id

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