Colorectal Cancer Clinical Trial
Official title:
A Single-centre, Randomized Study to Compare the Outcomes of Protected Transverse Colostomy Versus Ileostomy After Low Anterior Resection of Low Rectal Cancer From the Perspective of Intestinal Microecology
NCT number | NCT05853094 |
Other study ID # | FDCRC88-MYL |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 23, 2023 |
Est. completion date | May 2027 |
Exploring the effect of protective ileostomy compared with transverse colostomy on the occurrence of complications, the occurrence of serious side effects of adjuvant chemotherapy and disease recurrence in patients with low rectal cancer after radical surgery from the perspective of intestinal microecology.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 2027 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Pathological confirmed adenocarcinoma of the rectum; 2. Patients age between 18-80; 3. Baseline AJCC stage I-III: cT1-4N0-2M0 (AJCC-8 version); 4. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2; 5. Patients voluntarily sign informed consent. Exclusion Criteria: 1. Other types of rectal cancer (adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma); 2. Combination of rectal cancer with multiple carcinomas; 3. Pre-operative presence of acute and chronic infectious diseases or foci of infection; 4. Intraoperative radical surgery was not performed for various reasons; 5. Colostomy was not performed at the same time as the radical rectal cancer surgery; 6. Combined with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery; 7. Metastatic cancer; 8. Serious heart, lung, liver and kidney disease, can not tolerate surgery; 9. Active liver disease or abnormal liver function with ALT, AST and TBIL more than 2 times the upper limit of normal values; 10. Renal impairment with Cr = 2 times the upper limit of normal or BUN = 2 times the upper limit of normal; 11. Blood leukocytes below the lower limit of normal value, or platelets below the lower limit of normal value, or with other blood system diseases; 12. Pregnancy; 13. Mental illness or serious intellectual disability who cannot describe their feelings correctly; 14. Severe coagulation disorder, bleeding tendency; 15. Patients with severe uncontrolled medical disease, recent history of myocardial infarction (within 3 months), uncontrolled severe hypertension and severe diabetes mellitus; 16. Patients need to be on antibiotics/other probiotics for a long time. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing | Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing | 1 month | |
Primary | Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing | Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing | 6 months | |
Primary | Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing | Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing | 3 years | |
Secondary | Concentration of inflammatory markers | Measurement of plasma inflammatory markers such as IL-6, TNF-a, CRP and PCT | 1 month | |
Secondary | Changes in cellular immunity status | Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry | 1 month | |
Secondary | Changes in humoral immunity status | Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry | 1 month | |
Secondary | Incidence of anastomotic leakage | The occurrence of postoperative anastomotic leakage | 1 month | |
Secondary | Early postoperative complications rate | Incidence of postoperative complications such as diarrhea, intestinal obstruction, incisional infection, stoma prolapse, stoma necrosis, parastomal hernia, irritant dermatitis, renal insufficiency, etc. | 1 month | |
Secondary | First intestinal gas time | Documenting the patient's post-operative recovery | 1 month | |
Secondary | First defecation time | Documenting the patient's post-operative recovery | 1 month | |
Secondary | Concentration of inflammatory markers | Measurement of plasma inflammatory markers such as IL-6, TNF-a, CRP and PCT | 6 month | |
Secondary | Changes in cellular immunity status | Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry | 6 month | |
Secondary | Changes in humoral immunity status | Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry | 6 month | |
Secondary | Incidence of grade 3-4 serious side effects of adjuvant chemotherapy | Assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 6 month | |
Secondary | Adjuvant chemotherapy toxicity and quality of life scores | Assessed with European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29), ranging from 29 to 116 and higher scores suggest worse quality of life | 6 months | |
Secondary | Concentration of inflammatory markers | Measurement of plasma inflammatory markers such as IL-6, TNF-a, CRP and PCT | 3 years | |
Secondary | Changes in cellular immunity status | Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry | 3 years | |
Secondary | Changes in humoral immunity status | Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry | 3 years | |
Secondary | Disease-free Survival | Time between the start of surgical randomization and recurrence of disease or death (from any cause)Time between the start of surgical randomization and recurrence of disease or death (from any cause) | 3 years | |
Secondary | Overall Survival | Time from the start of surgical randomization to death (from any cause) | 3 years |
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