Postoperative Pain and Tenesmus After Doppler-Guided Hemorrhoidal Artery Ligation With or Without Mucopexy
Comparison of Postoperative Pain and Tenesmus Between Doppler-Guided Hemorrhoidal Artery Ligation Alone and Doppler-Guided Hemorrhoidal Artery Ligation Combined With Mucopexy in Patients With Hemorrhoidal Disease
Hemorrhoidal disease is one of the most common anorectal disorders affecting adults worldwide. Doppler-guided hemorrhoidal artery ligation (HAL) is a minimally invasive surgical technique that has gained popularity because of its lower postoperative pain and faster recovery compared with conventional hemorrhoidectomy. In selected patients, HAL may be combined with mucopexy to address prolapsing hemorrhoidal tissue.
The aim of this prospective study is to compare postoperative pain and tenesmus between patients undergoing Doppler-guided hemorrhoidal artery ligation alone and those undergoing Doppler-guided hemorrhoidal artery ligation combined with mucopexy.
Patients diagnosed with hemorrhoidal disease and scheduled for surgical treatment at the General Surgery Department of Tokat Gaziosmanpaşa University Hospital will be enrolled after obtaining ethics committee approval and informed consent. Eligible participants will be adults aged 18 years and older without any concomitant anal canal disease. Participants will be allocated into two groups according to the surgical technique performed: (1) Doppler-guided hemorrhoidal artery ligation alone and (2) Doppler-guided hemorrhoidal artery ligation combined with mucopexy.
Postoperative pain will be assessed using a pain scale at the 8th postoperative hour and at the 1st postoperative month. Tenesmus symptoms will be evaluated and recorded at the 2nd postoperative month. The primary outcomes will be postoperative pain scores and the presence of tenesmus. Comparative statistical analyses will be performed between the two groups.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ali Genç, Assistant professor
- 電話番号：+90-5442280060 +90-3562129500
- メール：aligenc0860@outlook.com
研究連絡先のバックアップ
- 名前：Muzaffer Katar, Associate Professor
- 電話番号：0 (356) 212 95 00 - 7515
- メール：Muzaffer.katar@gop.edu.tr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of hemorrhoidal disease requiring surgical treatment
- Ability to provide written informed consent
- Willingness to participate in the study.
Exclusion Criteria:
- Age below 18 years
- Presence of other anal canal diseases (anal fissure, anal fistula, anorectal malignancy, inflammatory bowel disease involving the anorectal region, etc.)
- Previous anorectal surgery that may affect study outcomes
- Inability or unwillingness to provide informed consent.
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：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HAL + Mucopexy
Participants will undergo Doppler-guided hemorrhoidal artery ligation combined with mucopexy for the treatment of hemorrhoidal disease.
Hemorrhoidal arteries will be identified using Doppler guidance and ligated, followed by mucopexy to reposition prolapsing hemorrhoidal tissue.
|
Doppler-guided hemorrhoidal artery ligation will be performed using a Doppler-equipped proctoscope to identify and ligate hemorrhoidal arteries.
Following arterial ligation, mucopexy will be performed to lift and secure the prolapsing hemorrhoidal mucosa.
|
|
アクティブコンパレータ：HAL Alone
Participants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease.
Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy.
|
Participants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease.
Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy.
|
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 |
|---|---|---|
|
Postoperative Pain Score (VAS)
時間枠：Postoperative Hour 8
|
Assessment of pain severity using the Visual Analog Scale (VAS) at the 8th postoperative hour.
|
Postoperative Hour 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Score
時間枠：1 month after surgery
|
Assessment of pain severity using the Visual Analog Scale (VAS) at the 1st postoperative month.
|
1 month after surgery
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。