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.
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
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms Malignant, Intestinal Neoplasms, Malignant
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Ileostomy | Experimental | Protective ileostomy as a defunction mean after low anterior resection Receives: Procedure: Ileostomy |
| Transverse colostomy | Experimental | Protective 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.
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
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
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)
Concentration of inflammatory markers
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Measured: 1 month
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
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
Incidence of anastomotic leakage
The occurrence of postoperative anastomotic leakage
Measured: 1 month
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
First intestinal gas time
Documenting the patient's post-operative recovery
Measured: 1 month
First defecation time
Documenting the patient's post-operative recovery
Measured: 1 month
Concentration of inflammatory markers
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Measured: 6 month
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
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
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
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
Concentration of inflammatory markers
Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT
Measured: 3 years
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
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
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
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.
- First posted10 May 2023
- Study start23 Jun 2023 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Yanlei, Fudan University
- Investigators
- Yanlei Ma, PhD, Principal investigator, Fudan University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05853094
- Acronym / sponsor ID
- FDCRC88-MYL
- Keywords
- Colorectal Cancer, Stoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 23 Jun 2023 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ileostomy | Experimental | Procedure: IleostomyProtective ileostomy as a defunction mean after low anterior resection |
| Transverse colostomy | Experimental | Procedure: Transverse colostomyProtective transverse colostomy as a defunction mean after low anterior resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IleostomyProtective loop ileostomy after low anterior resection | Procedure or surgery | Ileostomy |
| Transverse colostomyProtective loop transverse colostomy after low anterior resection | Procedure or surgery | Transverse colostomy |
Primary outcome
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Time frame: 1 month
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Time frame: 6 months
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
Microbiome functional gene capacity in postoperative stoma pouch and distal intestine by metagenomic sequencing
Time frame: 3 years
Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing
17 secondary outcomes
Concentration of inflammatory markers
Time frame: 1 month
Changes in cellular immunity status
Time frame: 1 month
Changes in humoral immunity status
Time frame: 1 month
Incidence of anastomotic leakage
Time frame: 1 month
Early postoperative complications rate
Time frame: 1 month
First intestinal gas time
Time frame: 1 month
First defecation time
Time frame: 1 month
Concentration of inflammatory markers
Time frame: 6 month
Changes in cellular immunity status
Time frame: 6 month
Changes in humoral immunity status
Time frame: 6 month
Incidence of grade 3-4 serious side effects of adjuvant chemotherapy
Time frame: 6 month
Adjuvant chemotherapy toxicity and quality of life scores
Time frame: 6 months
Concentration of inflammatory markers
Time frame: 3 years
Changes in cellular immunity status
Time frame: 3 years
Changes in humoral immunity status
Time frame: 3 years
Disease-free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanlei Ma, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
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.