RecruitingNot Applicable

Postoperative Effects of Different Enterostomy Approaches

China300 participantsStarted 2023-06-23

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing

Timeframe: 1 month

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing

Timeframe: 6 months

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing

Timeframe: 3 years

Trial details

NCT IDNCT05853094

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Yanlei Ma, PhD

(86)13122680635 yanleima@fudan.edu.cn

View on ClinicalTrials.gov More Colorectal Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing

Timeframe: 1 month

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing

Timeframe: 6 months

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing

Timeframe: 3 years