Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids (HemEmbo)
Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.
The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.
A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- University of Colorado Health
-
主任研究者：
- Jonathan Lindquist, MD
-
コンタクト：
- Alejandra Aguilar, MPH, CCRP, CPH
- 電話番号：7208486612
- メール：alejandra.aguilar@cuanschutz.edu
-
-
参加基準
適格基準
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:
- Male or female, aged >18 years
- Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
- French bleeding score > 5
- Rectal bleeding greater than 3 months
- Colonoscopy within three years, negative for colorectal malignancy
- INR < 1.5
- Platelet count > 150,000/dL
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after intervention
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
- Current use of anticoagulants and/or DAPT
- Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
- Prior surgical or endovascular treatment of hemorrhoids
- Prior endoscopic hemorrhoid artery ligation
- Pregnancy or lactation
- Known severe allergic reactions to iodinated contrast not mitigated by standard prophylaxis
- Bleeding attributable to other anorectal pathology such as anal fissures, anorectal abscess, or fistula
- Inflammatory bowel disease
- Inflammatory vasculitis or connective tissue disease
- Current participation in another clinical trial which may interfere with participation in this study
- Treatment with bevacizumab within 2 months
- Contraindication to surgical management of internal hemorrhoids
- Primary or secondary malignancy involving the abdomen or pelvis which is likely to impact treatment
- Prior pelvic radiation therapy
- Prior diagnosis of portal hypertension
- Major comorbidities expected to impact outcomes or increase patient risk, in the judgement of the enrolling physician
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：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Rectal Artery Embolization
Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
A minimally invasive procedure in which a doctor uses imaging guidance to place a small catheter into an artery and injects embolization materials to block the blood vessels supplying the hemorrhoids. This reduces blood flow and helps shrink the hemorrhoids. |
|
アクティブコンパレータ：Operative Hemorrhoidectomy
Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
A surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life Following Treatment
時間枠：Baseline and 1 month after treatment
|
Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life. |
Baseline and 1 month after treatment
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Return to Work
時間枠：From treatment through return to work or normal activities, up to 6 months after treatment
|
Comparison of time to return to work following superior rectal artery embolization and open surgical hemorrhoidectomy. |
From treatment through return to work or normal activities, up to 6 months after treatment
|
|
Time to Return to Pre-Intervention Activities
時間枠：From treatment until return to pre-intervention activities, up to 6 months after treatment
|
Comparison of time to return to pre-intervention activities following superior rectal artery embolization and open surgical hemorrhoidectomy as measured by selected elements of the adapted VEINES questionnaire. Scores range from 3 to 12, with higher scores indicating less limitation in daily, social, and leisure activities and therefore better functional recovery. Lower scores indicate greater activity limitation and poorer functional recovery. |
From treatment until return to pre-intervention activities, up to 6 months after treatment
|
|
Achievement of French Bleeding Score <2
時間枠：6 months after treatment
|
Comparison of proportion of patients that achieve French Bleeding Scores < 2 following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. For the French Bleeding Score, total scores range from 0 to 9, with lower scores indicating less bleeding and better clinical outcomes, and higher scores indicating more severe hemorrhoidal bleeding and worse clinical outcomes. |
6 months after treatment
|
|
Treatment-Related Adverse Events
時間枠：From treatment through 6 months after treatment
|
Comparison of adverse events following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. |
From treatment through 6 months after treatment
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlation of Rectal Arterial Anatomy With Clinical Outcomes
時間枠：Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.
|
Evaluate number and size of arteries and correlate with observed outcomes. |
Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 25-0192
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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