Rectal Cancer Clinical Trial
Official title:
Alterations of Gut Microbiome, Function, and Its Intervention After Total Mesorectal Excision With Defunctioning Ileostomy for Mid-low Rectal Cancer
Verified date | March 2023 |
Source | Huashan Hospital |
Contact | Jianbin Xiang |
Phone | 52887040 |
xjbzhw[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. The investigators looked forward to find the specific intestinal maladjusted flora from this work, which could provide a new scheme for the subsequent treatment of the damaged intestinal function and the reduction of the incidence of postoperative complication.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | July 17, 2024 |
Est. primary completion date | July 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients with primary rectal cancer received total mesolectal resection combined with defunctioning ileostomy. 2. Patients voluntarily sign informed consent. Exclusion Criteria: 1. Disease progression or death after surgery. 2. Patients with inflammatory bowl disease. 3. Patients need to be on antibiotics/other probiotics for a long time. |
Country | Name | City | State |
---|---|---|---|
China | Huashan hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wexner incontinence score | Assess defecation function,the score range is 0-20, 0 is normal, 20 is complete incontinence | 1 year | |
Secondary | fecal incontinence quality-of-life scale | The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items). The score of each scale is 1-4 points. The higher the score, the worse the quality of life. | 1 year | |
Secondary | Rate of postoperative complications | Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection,etc. | 1 month after operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 |