Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal Cancer (PKUCH-R10)
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
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Aiwen Wu, M.D.
- 電話番号：+8613911577190
- メール：wuaw@sina.com
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- 募集
- Beijing Cancer Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental
methylene blue injection |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants with successful stoma closure within 12 months after surgery
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with postoperative surgical complications within 30 days after surgery
時間枠：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. |
30 days after surgery
|
|
Number of participants with methylene blue-related adverse events within 30 days after surgery
時間枠：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. |
30 days after surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PKUCH-R10
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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