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

What Was Tested

The trial (phase 2) is built around Methylene blue (non-peptide stack partner).

It had 1 arm (groups): Experimental (experimental).

Methylene blue injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults aged 18 years or older with histologically confirmed rectal adenocarcinoma. 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.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: 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 contraindications or known hypersensitivity to methylene blue injection.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-11-25 with completion listed for 2027-07-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of participants with successful stoma closure within 12 months after surgery (time frame: 12 months after surgery).

It also tracked 2 secondary outcomes, for example Number of participants with postoperative surgical complications within 30 days after surgery and Number of participants with methylene blue-related adverse events within 30 days after surgery.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Methylene blue (non-peptide stack partner) in 26 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.