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

NCT07833319 | Recruiting Phase 2

• 1 other identifier: PKUCH-R10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancers

Keywords

Rectal cancer; methylene blue; defunctioning stoma

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with successful stoma closure within 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.

  12 months after surgery

Secondary Outcomes (2)

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

  30 days after surgery

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

  30 days after surgery

Study Arms (1)

Experimental

EXPERIMENTAL

methylene blue injection

Drug: methylene blue injection

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Aiwen Wu, M.D.

CONTACT

+8613911577190; wuaw@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: September 22, 2026
• Study Start: November 25, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)