NCT05853094Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 10 Apr 2023
- Start date
- 23 Jun 2023
- Primary completion date
- May 2026
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT05853094
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 23 Jun 2023 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intraoperative radical surgery was not performed for various reasons；
Other illness
- 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;
- 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;
- Renal impairment with Cr ≥ 2 times the upper limit of normal or BUN ≥ 2 times the upper limit of normal;
- 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;
Lab values
- Active liver disease or abnormal liver function with ALT, AST and TBIL more than 2 times the upper limit of normal values;
- Blood leukocytes below the lower limit of normal value, or platelets below the lower limit of normal value, or with other blood system diseases;
Other
- Pregnancy;
- Patients need to be on antibiotics/other probiotics for a long time.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.