NCT05853094

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
12mo left

Started Jun 2023

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2023May 2027

First Submitted

Initial submission to the registry

April 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

April 10, 2023

Last Update Submit

May 17, 2023

Conditions

Colorectal CancerColorectal Neoplasms MalignantIntestinal Neoplasms, Malignant

Keywords

Colorectal CancerStoma

Outcome Measures

Primary Outcomes (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

    1 month

  • 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

  • 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 Outcomes (17)

  • Concentration of inflammatory markers

    1 month

  • Changes in cellular immunity status

    1 month

  • Changes in humoral immunity status

    1 month

  • Incidence of anastomotic leakage

    1 month

  • Early postoperative complications rate

    1 month

  • +12 more secondary outcomes

Study Arms (2)

Ileostomy

EXPERIMENTAL

Protective ileostomy as a defunction mean after low anterior resection

Procedure: Ileostomy

Transverse colostomy

EXPERIMENTAL

Protective transverse colostomy as a defunction mean after low anterior resection

Procedure: Transverse colostomy

Interventions

IleostomyPROCEDURE

Protective loop ileostomy after low anterior resection

Ileostomy
Transverse colostomyPROCEDURE

Protective loop transverse colostomy after low anterior resection

Transverse colostomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsIntestinal Neoplasms

Interventions

Ileostomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EnterostomyDigestive System Surgical ProceduresSurgical Procedures, OperativeOstomy

Study Officials

  • Yanlei Ma, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanlei Ma, PhD

CONTACT

(86)13122680635yanleima@fudan.edu.cn

Yichi Zhang, MD

CONTACT

(86)1858873191122111230058@m.fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 10, 2023

First Posted

May 10, 2023

Study Start

June 23, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

CN(1)