Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study
調査の概要
詳細な説明
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.
The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.
The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).
The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.
At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.
At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Clermont-Ferrand、フランス、63003
- 募集
- CHU de Clermont-Ferrand
-
-
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:
- patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
- benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.
and
- affiliation to social security and
- informed consent
Exclusion Criteria:
- ASA III or IV patients,
- age> 80 years old,
- history of major abdominal surgery by laparotomy
- severe obesity (BMI> 35kg / m2)
- pathology of hemostasis and coagulation (liver disease, bleeding disorders)
- uterine volume estimated on preoperative ultrasonography > 300 g
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to participate.
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：standard instrument
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
|
|
他の：less than 3 millimeter diameter's instruments
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
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 |
時間枠 |
|---|---|
|
operative time
時間枠：at day 1 (at the end of the surgery)
|
at day 1 (at the end of the surgery)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
quantity of intraoperative bleeding
時間枠：at day 1 (at the end of the intervention)
|
at day 1 (at the end of the intervention)
|
|
|
hemoglobin
時間枠：at day 1
|
at day 1
|
|
|
Pain Rating Scale (VAS)
時間枠：at day 1 (at 6 hours potoperative hours)
|
at day 1 (at 6 hours potoperative hours)
|
|
|
Pain Rating Scale (VAS)
時間枠：at day 1 (at 24 postoperative hours)
|
at day 1 (at 24 postoperative hours)
|
|
|
standard laparoscopy conversion rate
時間枠：at day 1
|
at day 1
|
|
|
postoperative complications
時間枠：at each additional hospitalisation
|
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
|
at each additional hospitalisation
|
|
Patient Scar Assessment Scale (PSAS)
時間枠：at 6 and 8 weeks after surgery.
|
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
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at 6 and 8 weeks after surgery.
|
|
Surgen's ergonomics
時間枠：at the end of the surgery
|
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
|
at the end of the surgery
|
協力者と研究者
捜査官
- 主任研究者：Revaz BOTCHORISHVILI、CHU de Clermont-Ferrand
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- CHU-0223
- 2014-A01698-39 (その他の識別子：ANSM)
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