直腸がん患者における低位前方切除症候群の治療のための腸管理プログラム（逆行性直腸浣腸）
低位前方切除症候群: 逆行性浣腸プログラム vs 医学的管理
This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.
SECONDARY OBJECTIVE:
I. The determination of feasibility to complete this treatment pathway.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.
GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.
Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.
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：The Ohio State Comprehensive Cancer Center
- 電話番号：800-293-5066
- メール：OSUCCCClinicaltrials@osumc.edu
研究場所
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University Comprehensive Cancer Center
-
コンタクト：
- Alessandra C. Gasior, DO
- 電話番号：614-722-3879
- メール：Alessandra.gasior@osumc.edu
-
主任研究者：
- Alessandra C. Gasior, DO
-
-
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:
- Age ≥ 18 years old
- Moderate to Severe LARS diagnosis
- Patients with history of rectal cancer that was treated with proctectomy
- Has undergone standard medical management without improvement of symptoms for 3-6 months
Exclusion Criteria:
- Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit
- Patients with any chemo or radiation therapy in the last 6 months
- Patients who currently have colorectal cancer
- Patients with recurrent colorectal cancer
- Patients who have undergone a colorectal surgical procedure within the last three months
- Patients with progressive neurological disease
- Patients with active or recurrent sacral infection
- Patients < 18 years old
- Active sacral nerve simulator
- Pregnant or planning to become pregnant during the treatment portion of the study
- Altered mental status or mental disability that would alter ability to self-administer enema
- Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)
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：支持療法
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group I (RRE, medical management)
Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial. |
Ancillary studies Receive dietary fiber
他の名前：
Undergo RRE
他の名前：
Receive loperamide hydrochloride
他の名前：
Undergo pelvic floor physical therapy
他の名前：
Undergo abdominal film x-ray
他の名前：
|
|
アクティブコンパレータ：Group II (medical management)
Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement. |
Ancillary studies Receive dietary fiber
他の名前：
Receive loperamide hydrochloride
他の名前：
Undergo pelvic floor physical therapy
他の名前：
|
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 |
|---|---|---|
|
Fecal incontinence
時間枠：Up to 1 year from start of treatment
|
Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire [MSKCC BFI]). Effect size (Cohen's d > 0.80) will be computed to ensure the effect of findings. P < 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
Up to 1 year from start of treatment
|
|
Effectiveness assessed using LARS validated scoring tool
時間枠：Up to 1 year from start of treatment
|
Will be assessed using LARS validated scoring tool. Effect size (Cohen's d > 0.80) will be computed to ensure the effect of findings. P < 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
Up to 1 year from start of treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility measured by Patient Satisfaction Survey
時間枠：At 1 year from start of treatment
|
Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d > 0.80) will be computed to ensure the effect of findings. P < 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
At 1 year from start of treatment
|
協力者と研究者
捜査官
- 主任研究者：Alessandra C Gasior, DO、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
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
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
- OSU-22312
- NCI-2024-03173 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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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