Skip to content

The safety study of the new model of rapid bowel preparation under the concept of ERAS before elective colorectal cancer surgery: a multicenter, randomized, controlled clinical trial

The safety study of the new model of rapid bowel preparation under the concept of ERAS before elective colorectal cancer surgery: a multicenter, randomized, controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033501
Enrollment
Unknown
Registered
2020-06-03
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

experimental group:ERAS method
control group:traditional method for intestinal preparation

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients with no previous colorectal surgery history; 2. Patients aged 18-90, male or non pregnant, lactating female; 3. All patients were operated by the same surgeon; 4. Nrs2002 score = 35 g / L, hemoglobin >= 100 g / L; 5. For the objects with good organ function, biochemical examination meets the following conditions: ALT <= 2.5 x ULN, AST <= 2.5 x ULN, total bilirubin <= 1.5 x ULN, creatinine <= 1.5 x ULN; 6. Patients with colorectal leakage score (CLS) less than or equal to 30; 7. Patients without contraindications for bowel preparation, such as chronic renal insufficiency and cardiac insufficiency; 8. Patients who voluntarily sign informed consent;

Exclusion criteria

Exclusion criteria: 1. Patients after new adjuvant treatment. 2. Patients whose colonoscopy was blocked by tumor and could not pass through intestinal cavity before operation or whose other data were incomplete. 3. Patients with multiple primary colorectal cancer or more than 2 times of intestinal anastomosis during operation. 4. Patients with intestinal obstruction, intestinal perforation and gastrointestinal bleeding before operation. 5. Patients with serious or uncontrolled internal diseases and infection (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, uncontrolled hypertension, COPD, chronic renal insufficiency, etc.); 6. Patients with obesity or excessive drinking, BMI >= 30 kg / m2. 7. Patients with other malignant tumor history in the past 5 years (excluding cured basal cell carcinoma, cervical carcinoma in situ, localized prostate cancer treated by surgery or breast ductal carcinoma in situ removed by surgery). 8. Patients with long-term use of immunosuppressants or steroids, or drug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or affect the evaluation of the results of the study; 9. Patients with severe ulcerative colitis or congenital megacolon. 10. Patients with natural and recombinant HGF, glycerin, mannitol and allergic history. 11. Patients with poor blood glucose control and HbA1c >= 10 g / L. 12. Patients who participated in other clinical trials in the past three months.

Design outcomes

Primary

MeasureTime frame
white blood cell;Reactive protein;Procalcitonin;Gut flora;Anastomotic healing;Anastomotic microcirculation;Enterography;

Secondary

MeasureTime frame
Blood routine;Liver and kidney function;Tumor markers;Tumor status assessment;Anastomotic healing;Anastomotic healing;

Countries

China

Contacts

Public ContactChunhui Cui

Zhujiang Hospital of Southern Medical University

87075472@qq.com+86 13570541388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026