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โ† Trials
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Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal Cancer

RecruitingPhase 2Ages 18 Years - anyAllPeking University Cancer Hospital & Institute
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In plain words

What the trial is, and whether it could suit you

Rectal cancer surgery has become increasingly effective, allowing many patients to avoid permanent colostomy. However, anastomotic leakage remains one of the most serious complications after rectal cancer surgery, especially in patients undergoing low anterior resection. Anastomotic leakage may lead to pelvic infection, prolonged hospitalization, additional treatments, and may affect the recovery of temporary diverting stomas. This investigator-initiated clinical study aims to evaluate the safety and potential effectiveness of local methylene blue injection around the pelvic floor after completion of colorectal anastomosis in patients with high-risk rectal cancer undergoing low anterior resection with a temporary diverting ileostomy. In this study, eligible patients will receive local injection of diluted methylene blue solution into the pelvic floor muscles surrounding the anastomosis

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged 18 years or older with histologically confirmed rectal adenocarcinoma. 2. Patients with mid or low rectal cancer (tumor located within 10 cm from the anal verge) who are scheduled to undergo curative low anterior resection with a temporary diverting ileostomy. 3. Patients with one or more risk factors associated with postoperative stoma non-closure or anastomotic complications, including male sex, narrow pelvis, neoadjuvant chemoradiotherapy, prolonged operative time, or increased intraoperative bleeding risk. 4. Patients who are considered suitable candidates for surgery and postoperative follow-up according to the investigator's assessment. 5. Patients who are willing to provide written informed consent. Exclusion Criteria: 1. Patients with emergency surgical conditions, including intestinal obstruction, bowel perforation, or acute abdominal infection before surgery. 2. Patients undergoing abdominoperineal resection, local excision, or other surgical procedures without colorectal anastomosis and diverting ileostomy. 3. Patients with other active malignancies or recurrent rectal cancer. Patients who are unable to tolerate the planned surgery or follow-up procedures. 4. Patients with contraindications or known hypersensitivity to methylene blue injection. 5. Patients with severe medical conditions or laboratory abnormalities that may increase study-related risks or interfere with study outcome evaluation.
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What it tests

  • methylene blue injection
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Where

1 site
Beijing Cancer Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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