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NCT Number: NCT07833319

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

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 after surgery. Participants will be followed for 12 months after surgery. The study will evaluate postoperative outcomes, including the occurrence of anastomotic leakage, complications related to the injection procedure, and whether the temporary stoma can be successfully reversed.

The information collected in this study may help determine whether local methylene blue injection is a safe and feasible approach for reducing postoperative complications and improving recovery after rectal cancer surgery.

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Key information

Conditions

Rectal Cancers Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older with histologically confirmed rectal adenocarcinoma.
  • 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.
  • 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.
  • Patients who are considered suitable candidates for surgery and postoperative follow-up according to the investigator's assessment.
  • Patients who are willing to provide written informed consent.

Exclusion criteria

  • Patients with emergency surgical conditions, including intestinal obstruction, bowel perforation, or acute abdominal infection before surgery.
  • Patients undergoing abdominoperineal resection, local excision, or other surgical procedures without colorectal anastomosis and diverting ileostomy.
  • Patients with other active malignancies or recurrent rectal cancer. Patients who are unable to tolerate the planned surgery or follow-up procedures.
  • Patients with contraindications or known hypersensitivity to methylene blue injection.
  • Patients with severe medical conditions or laboratory abnormalities that may increase study-related risks or interfere with study outcome evaluation.

Treatment and study plan

methylene blue injection

Drug

Eligible patients have mid-low locally advanced rectal adenocarcinoma (≤10 cm from anal verge) with at least one risk factor for stoma non-closure, scheduled for low anterior resection with defunctioning ileostomy. After anastomosis, 20 mL of 0.1% methylene blue is injected into the pelvic floor muscles.

Primary outcomes

  1. Proportion of participants with successful stoma closure within 12 months after surgery

    Time frame: 12 months after surgery

    Successful stoma closure is defined as reversal of the temporary diverting ileostomy within 12 months after low anterior resection. The outcome will be reported as the proportion of participants who undergo stoma closure among all enrolled participants.

Secondary outcomes

  1. Number of participants with postoperative surgical complications within 30 days after surgery

    Time frame: 30 days after surgery

    Postoperative surgical complications will be assessed within 30 days after surgery and reported as the number and proportion of participants experiencing at least one complication. Complications will be graded according to the Clavien-Dindo classification system. Assessed complications include, but are not limited to, anastomotic leakage, surgical site infection, bleeding, ileus, and other surgery-related complications.

  2. Number of participants with methylene blue-related adverse events within 30 days after surgery

    Time frame: 30 days after surgery

    Methylene blue-related adverse events will be within 30 days after surgery and reported as the number and proportion of participants experiencing adverse events considered related to local methylene blue injection. Assessed events include local tissue irritation, injection-site pain, tissue necrosis, allergic reactions, and other unexpected adverse events related to methylene blue administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Aiwen Wu, M.D.

CONTACT

[email protected]

+8613911577190

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

A Prospective Single-arm Phase II Clinical Study Evaluating Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma in High-risk Patients With Rectal Cancer Undergoing Low Anterior Resection

Acronym: PKUCH-R10

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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