Local methylene blue injection around the pelvis to help avoid leakage after rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigator-initiated Phase 2 trial evaluates the safety and potential effectiveness of a local methylene blue injection around the pelvic floor after colorectal anastomosis in high-risk rectal cancer patients undergoing low anterior resection with a temporary ileostomy. Eligible participants will receive a local injection of diluted methylene blue into pelvic-floor muscles surrounding the anastomosis during the postoperative period and will be followed for 12 months. Outcomes will focus on safety and signals of reduced anastomotic leakage and stoma-related complications. The study is conducted at Beijing Cancer Hospital under the lead sponsorship of Peking University Cancer Hospital & Institute.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Aiwen Wu, M.D.
• Email: wuaw@sina.com
• Phone: +8613911577190

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.