Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
A prospective randomized clinical trial of patients undergoing bariatric surgery.
Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
調査の概要
詳細な説明
A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.
Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
研究の種類
入学 (実際)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- patients with body mass index (BMI) >40 Kg/m2 or BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.
Exclusion Criteria:
- all kind of previous breast surgery.
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：防止
- 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：PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
|
The participants underwent one 30-min session every week for 12 consecutive weeks.
PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm.
PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain.
PENS was delivered simultaneously in both pectoral muscles.
Patients underwent specific training exercises to improve pectoral fitness.
|
|
アクティブコンパレータ：Specific training
Patients undergoing specific training during 12 weeks postoperatively
|
Patients underwent specific training exercises to improve pectoral fitness.
|
|
介入なし：No intervention
No specific treatment was assigned to these patients postoperatively
|
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 |
|---|---|---|
|
Satisfaction degree. 7-points Likert scale was used for the quantification.
時間枠：12 weeks of treatment
|
The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.
|
12 weeks of treatment
|
協力者と研究者
捜査官
- 主任研究者：Jaime Ruiz-Tovar, MD, PhD、Hospital General Elche
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
その他の研究ID番号
- HURJC2015-02
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