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Colorectal CancerNCT05853094

Postoperative Effects of Different Enterostomy Approaches

A study testing Ileostomy and Transverse colostomy in people with Colorectal Cancer and Colorectal Neoplasms Malignant, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ileostomy and Transverse colostomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
23 Jun 2023to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Yanlei Ma, PhD, (86)13122680635, yanleima@fudan.edu.cn

    Yichi Zhang, MD, (86)18588731911, 22111230058@m.fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Low rectum refers to the rectal area <7 cm from the anal verge. At present, with the development of modern medical technology and the change of surgical concept, more and more patients can achieve the goal of radical treatment of low rectal cancer while preserving the anus. The occurrence of anastomotic leakage after anus-preserving surgery for low-grade rectal cancer is a more common and serious complication, with an incidence ranging from 2.4% to 15.9%, and the morbidity and mortality rate after anastomotic leakage can be as high as 16%.

A protective stoma protects the anastomosis by temporarily establishing an artificial channel above the anastomosis to divert feces and avoid mechanical pressure and contamination of the anastomosis by intestinal contents, allowing the anastomosis to grow and heal in relatively clean external conditions. The current choices of protective stoma sites are terminal ileum and transverse colon. Analysis of domestic and international studies shows that both protective transverse colostomy and ileostomy can achieve the effect of diversion of stool, but whether there is a difference in preventing anastomotic leakage and reducing adverse outcomes of anastomotic leakage remains to be investigated. There are significant inconsistencies between domestic and international studies regarding the incidence of stoma-related complications caused by different stoma sites: the study by Rondelli et al. showed that terminal ileostomy was associated with lower stoma-related complications, and a domestic meta-analysis recommended terminal ileostomy after radical rectal cancer surgery. In contrast, the study by the team from the Union Hospital showed that transverse colostomy was associated with significantly lower rates of stoma-related complications and perioperative complications of stoma reentry.

In addition, according to the Union Hospital team study, the incidence of postoperative intestinal microbiota dysbiosis was higher in patients who underwent ileostomy compared to those who underwent transverse colostomy. The total intestinal microbiota in the colon accounts for more than 90% of the systemic intestinal microbiota, and the intestinal microbiota in the large intestine can be roughly restored to preoperative levels after transverse colostomy, whereas a large amount of intestinal microbiota is lost and difficult to restore after ileostomy. The dominant flora in the colon, such as Clostridium and Enterococcus, are less likely to colonize the small intestine, which may adversely affect the intestinal and systemic immune regulation and antitumor immune effects of the body. In addition, patients with progressive low-grade rectal cancer routinely require adjuvant chemotherapy after radical surgery, and there are no studies at domestic or abroad on whether terminal ileostomy, which is more common than transverse colostomy for intestinal dysbiosis, has any differences on the efficacy and toxic side effects of adjuvant chemotherapy for patients; furthermore, it is also important to investigate whether the two different stoma methods have an impact on long-term disease recurrence and overall survival of patients. In addition, whether the two different stoma modalities have an effect on long-term disease recurrence and overall survival is also an important research question.

Therefore, the investigators propose to conduct a prospective, randomized, controlled study in patients with low-grade rectal cancer who underwent radical surgery (with or without neoadjuvant radiotherapy) to investigate whether there are differences in the incidence of complications, serious side effects of adjuvant chemotherapy, and disease recurrence after terminal ileostomy versus transverse colostomy from the perspective of intestinal microecology, and to explore the differences in systemic immunity, inflammatory, and metabolic status.

Being tested
Ileostomy, Transverse colostomy
Keywords
Colorectal Cancer, Stoma
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Intestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IleostomyProcedure or surgery

    Protective loop ileostomy after low anterior resection

  • Transverse colostomyProcedure or surgery

    Protective loop transverse colostomy after low anterior resection

Study groups in NCT05853094
Study groupRoleWhat they receive
IleostomyExperimentalProtective ileostomy as a defunction mean after low anterior resection
Receives: Procedure: Ileostomy
Transverse colostomyExperimentalProtective transverse colostomy as a defunction mean after low anterior resection
Receives: Procedure: Transverse colostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 3 years

Secondary outcomes (17)
  1. Concentration of inflammatory markers

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

    Measured: 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

    Measured: 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

    Measured: 1 month

  4. Incidence of anastomotic leakage

    The occurrence of postoperative anastomotic leakage

    Measured: 1 month

  5. Early postoperative complications rate

    Incidence of postoperative complications such as diarrhea, intestinal obstruction, incisional infection, stoma prolapse, stoma necrosis, parastomal hernia, irritant dermatitis, renal insufficiency, etc.

    Measured: 1 month

  6. First intestinal gas time

    Documenting the patient's post-operative recovery

    Measured: 1 month

  7. First defecation time

    Documenting the patient's post-operative recovery

    Measured: 1 month

  8. Concentration of inflammatory markers

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

    Measured: 6 month

  9. 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

    Measured: 6 month

  10. Changes in humoral immunity status

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

    Measured: 6 month

  11. Incidence of grade 3-4 serious side effects of adjuvant chemotherapy

    Assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: 6 month

  12. Adjuvant chemotherapy toxicity and quality of life scores

    Assessed with European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29), ranging from 29 to 116 and higher scores suggest worse quality of life

    Measured: 6 months

  13. Concentration of inflammatory markers

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

    Measured: 3 years

  14. 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

    Measured: 3 years

  15. Changes in humoral immunity status

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

    Measured: 3 years

  16. Disease-free Survival

    Time between the start of surgical randomization and recurrence of disease or death (from any cause)Time between the start of surgical randomization and recurrence of disease or death (from any cause)

    Measured: 3 years

  17. Overall Survival

    Time from the start of surgical randomization to death (from any cause)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start23 Jun 2023 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853094
Sponsor's protocol ID
FDCRC88-MYL
Status last verified
May 2023
First submitted
10 Apr 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ileostomy and Transverse colostomy in people with Colorectal Cancer and Colorectal Neoplasms Malignant, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanlei Ma, PhD ((86)13122680635, yanleima@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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Clinical Trial NCT05853094 | AzTrials