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Compares treatment options for Rectal Cancer
Official title Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection
ClinicalTrials.gov ID: NCT07605611
What this study is testing
What is Somatostatin?
Somatostatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery.
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adults aged 18 to 75 years
- Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
- The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging...
- The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
- Patients have two or more risk factors for anastomotic leakage as assessed by the study team
You likely can't join if
- Has another colorectal malignant tumor at the same time
- The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
- Has metastatic disease before surgery
- Is pregnant
- Has a mental illness or addictive disorder that would prevent participation in the clinical trial
- Requires emergency surgery
See the full eligibility criteria
- Adults aged 18 to 75 years
- Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
- The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination
- The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
- Patients have two or more risk factors for anastomotic leakage as assessed by the study team
- American Society of Anesthesiologists physical status classification is grade 3 or lower
- Body mass index is less than 30 kg/m²
- The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent
- Has another colorectal malignant tumor at the same time
- The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
- Has metastatic disease before surgery
- Is pregnant
- Has a mental illness or addictive disorder that would prevent participation in the clinical trial
- Requires emergency surgery
- Has inflammatory bowel disease
- Is allergic to somatostatin or is unable to tolerate somatostatin
- For participants assigned to the no-stoma group, the surgeon decides that a stoma is required
- Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery
- Has any other condition that makes it impossible to follow the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Ezhou, Hubei, China
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ezhou, Hubei, China; Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.