Post-Op Quality of Life After Colorectal Surgery
2014年12月12日 更新者：Conor Delaney, MD, PhD、University Hospitals Cleveland Medical Center
Postoperative Quality of Life: Development and Assessment of a Novel Tool to Assess Quality of Life Following Colorectal Surgery
The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire - to accurately assess early quality of life in patients after abdominal colorectal surgery from the first day after surgery to 6 months after.
The study will also compare this questionnaire to the other currently available assessment tools.
Patients are invited to participate if they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.
調査の概要
詳細な説明
The purpose of this study is to produce a user-friendly tool to accurately assess early quality of life in postoperative patients following abdominal colorectal surgery in the early postoperative period (from surgery to 6 months) that is practical for routine application.
The study will also compare this tool to the current available tools, namely the Short Form (SF-36), the short form inflammatory bowel disease questionnaire (IBDQ), the Cleveland Clinic Global Quality of Life (CGQOL).
Patients will be invited to participate if they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.
研究の種類
観察的
入学 (実際)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44106
- University Hospitals of Cleveland
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients scheduled to undergo laparscopic or open procedures from the Deopartment of Surgery at University Hospitals of Cleveland.
説明
Inclusion Criteria:
- Subjects who are 18 years of age and older
- Subjects of either sex
- Subjects who will undergo any colorectal abdominal surgery at University Hospitals of Cleveland
- Subjects who agree to participate in the study program and provide written informed consent
- Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and diverticulitis
Exclusion Criteria:
- Patients in the middle of three part surgery or had recent surgery (i.e., back for stoma closure for J-pouch)
- Patients with diagnosis of rectal prolapse, condyloma or any other condition that cannot be performed abdominally with an open or laparoscopic procedure
- Patient who have undergone major surgery within the month prior to this colorectal surgery
- Pregnant women, minors, psychiatric patients and prisoners
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
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 |
|---|---|---|
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Evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
時間枠：1 month to 1 hour prior to surgery
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The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
We would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.
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1 month to 1 hour prior to surgery
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Evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
時間枠：2 weeks post operatively
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The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
We would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.
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2 weeks post operatively
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Evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
時間枠：4 weeks post operatively
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The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
We would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.
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4 weeks post operatively
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Evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
時間枠：6 months post-operatively
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The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
We would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.
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6 months post-operatively
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Evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients
時間枠：1 year post-operatively
|
The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.
We would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.
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1 year post-operatively
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Conor Delaney, MD, PhD、University Hospitals of Cleveland/ Institute for Surgical Innovation
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年10月1日
一次修了 (実際)
2008年4月1日
研究の完了 (実際)
2008年5月1日
試験登録日
最初に提出
2007年5月1日
QC基準を満たした最初の提出物
2007年5月1日
最初の投稿 (見積もり)
2007年5月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月15日
QC基準を満たした最後の更新が送信されました
2014年12月12日
最終確認日
2014年12月1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。