開腹腹壁再建のための術前減量
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Benjamin T Miller, MD
- 電話番号：216 406-8573
- メール：millerb35@ccf.org
研究連絡先のバックアップ
- 名前：Erika Schmidt, MD
- 電話番号：2163723107
- メール：schmide7@ccf.org
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60611
- 募集
- Northwestern University
-
コンタクト：
- Megan Melland-Smith, MD
- 電話番号：312-907-1414
- メール：megan.mellandsmith@nm.org
-
コンタクト：
- Nancy Ly, MD
- 電話番号：262-455-1560
- メール：nancy.ly@nm.org
-
主任研究者：
- Megan Melland-Smith, MD
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- 募集
- Cleveland Clinic Main Campus
-
コンタクト：
- Benjamin T Miller, MD
- 電話番号：2164068573
- メール：millerb35@ccf.org
-
-
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
- Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
- BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.
Exclusion criteria
- Lack of English language fluency
- Urgent need for repair as determined by surgeon judgement
- Pregnant patients
- Permanent stoma in place
- Isolated flank hernia
- Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.
- BMI <40 or >55 kg/m2
- Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).
- Obstructive symptoms
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：独身
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 |
|---|---|
|
介入なし：事前の手術
|
|
|
アクティブコンパレータ：術前体重管理プログラム
|
The medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days. |
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 |
|---|---|---|
|
Abdominal core health-specific quality of life at 1 year
時間枠：1 year
|
This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life. |
1 year
|
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 |
|---|---|---|
|
Hernia recurrence at 1 year
時間枠：1 year
|
This will be based on based on the current consensus definition of hernia recurrence which considers CT scan reviewed by 3 blinded assessors, surgeon clinical exam, and patient-reported bulge. |
1 year
|
|
Wound morbidity at 30 days
時間枠：30 days
|
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention. |
30 days
|
|
Wound morbidity at 1 year
時間枠：1 year
|
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention. |
1 year
|
|
Body composition changes in weight
時間枠：1 year
|
This includes comparative mean changes in body weight (kg) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up. |
1 year
|
|
Body composition changes in BMI
時間枠：1 year
|
This includes comparative mean changes in BMI (kg/m2) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up. |
1 year
|
|
Patient abdominal wall specific- quality of life with preoperative weight management program
時間枠：1 year
|
This includes difference in abdominal wall-specific quality of life using the HerQLes score (0-100 with higher scores indicating better abdominal wall-specific quality of life) in the weight loss arm before and after weight loss intervention. |
1 year
|
|
Patient-reported pain changes with preoperative weight management program
時間枠：1 year
|
This includes difference in pain using the PROMIS 3a Pain Intensity Score (30.7-71.8 with higher scores indicating more pain) in the weight loss arm before and after weight loss intervention. |
1 year
|
|
Patient-reported quality of life changes with preoperative weight management program
時間枠：1 year
|
This includes difference in overall quality of life using the EQ5D-5L with VAS (scored with an index value and a 0-100 score with higher scores indicating better quality of life) in the weight loss arm before and after weight loss intervention. |
1 year
|
|
Abdominal wall -specific quality of life short-term
時間枠：30 days
|
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively. |
30 days
|
|
Pain scores
時間枠：1 year
|
This includes the difference in pain scores using the PROMIS 3a Pain Intensity Score (scored from 30.7-71.8) at baseline, 30-day, and 1 year. |
1 year
|
|
Cost effective analysis
時間枠：1 year
|
Perform a formal cost effectiveness analysis. |
1 year
|
|
Body weight percentage loss
時間枠：1 year
|
Proportion of patients achieving a reduction in 5% and 10% body weight at end of 6-month medical weight loss intervention, day of surgery, and 1-year follow-up |
1 year
|
|
Weight management program adherence
時間枠：1 year
|
Proportion of successful completion of the program (defined as attending at least 4 visits) is associated with lower wound complications, hernia recurrence, or higher HerQLes score at one year |
1 year
|
|
Impact of 10% body weight loss on wound complications
時間枠：1 year
|
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare proportion of wound complications |
1 year
|
|
Impact of 10% body weight loss on hernia recurrence
時間枠：1 year
|
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare hernia recurrence at one year |
1 year
|
|
Impact of 10% body weight loss
時間枠：1 year
|
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare HerQLes score (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year |
1 year
|
|
Urgent repair
時間枠：1 year
|
Number of patients who require urgent hernia repair in either arm |
1 year
|
|
Bariatric surgery prior to hernia repair and wounds
時間枠：1 year
|
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of wound complications at one year |
1 year
|
|
Bariatric surgery prior to hernia repair and hernia recurrence
時間枠：1 year
|
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of hernia recurrence at one year |
1 year
|
|
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
時間枠：1 year
|
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair and HerQLes scores (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year |
1 year
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Benjamin T Miller, MD、The Cleveland Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 23-418
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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