RecruitingNot ApplicableNCT05853094

Postoperative Effects of Different Enterostomy Approaches

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

Sponsor

Fudan University

Enrollment

300 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Colorectal Neoplasms Malignant Intestinal Neoplasms, Malignant

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Pathological confirmed adenocarcinoma of the rectum;
Patients age between 18-80;
Baseline AJCC stage I-III: cT1-4N0-2M0 (AJCC-8 version);
Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;
Patients voluntarily sign informed consent.

Exclusion Criteria16

Other types of rectal cancer (adenosquamous carcinoma, squamous carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma);
Combination of rectal cancer with multiple carcinomas;
Pre-operative presence of acute and chronic infectious diseases or foci of infection;
Intraoperative radical surgery was not performed for various reasons；
Colostomy was not performed at the same time as the radical rectal cancer surgery;
Combined with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery;
Metastatic cancer;
Serious heart, lung, liver and kidney disease, can not tolerate surgery;
Active liver disease or abnormal liver function with ALT, AST and TBIL more than 2 times the upper limit of normal values;
Renal impairment with Cr ≥ 2 times the upper limit of normal or BUN ≥ 2 times the upper limit of normal;
Blood leukocytes below the lower limit of normal value, or platelets below the lower limit of normal value, or with other blood system diseases;
Pregnancy;
Mental illness or serious intellectual disability who cannot describe their feelings correctly;
Severe coagulation disorder, bleeding tendency;
Patients with severe uncontrolled medical disease, recent history of myocardial infarction (within 3 months), uncontrolled severe hypertension and severe diabetes mellitus;
Patients need to be on antibiotics/other probiotics for a long time.