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Postoperative Effects of Different Enterostomy Approaches

ConditionsColorectal CancerColorectal Neoplasms MalignantIntestinal Neoplasms, Malignant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ileostomy

    Procedure/Surgery

    Protective loop ileostomy after low anterior resection

  • Transverse colostomy

    Procedure/Surgery

    Protective loop transverse colostomy after low anterior resection

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: IleostomyExperimental treatment 1 intervention
Group B: Transverse colostomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 month
2

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

Time frame
6 months
3

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

Time frame
3 years

Secondary outcomes

1

Concentration of inflammatory markers

Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT

Time frame
1 month
2

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

Time frame
1 month
3

Changes in humoral immunity status

Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry

Time frame
1 month
4

Incidence of anastomotic leakage

The occurrence of postoperative anastomotic leakage

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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