経膣自然開口部経管内視鏡手術による子宮摘出術と腹腔鏡下子宮摘出術の比較 (vNOTESHC)
vNOTEsHC: 経膣自然開口部経管内視鏡手術による子宮摘出術と腹腔鏡下子宮摘出術の比較: ランダム化比較試験
In France, there are approximately 62,000 hysterectomies per year, 70% of which are benign. It is the most frequent surgical procedure in gynecology.
Hysterectomies are performed via 3 routes: laparotomy, laparoscopy or vaginal route.
This choice of approach is particularly important in the case of large uteri (50% of uteri > 280g), which increase the risks of laparoconversion and bladder injury (NP3).
The vaginal route reduces the operating time and postoperative pain. Laparoscopy allows a better anatomical view and easier access to the neighbouring organs, which makes it the preferred approach, especially for young surgeons and when the uterus is large. However, the laparoscopic route is associated with an increase in the rate of conversion to laparotomy according to the volume of the uterus, as well as the rate of general per and postoperative complications compared with vaginal hysterectomy for uteri > 280 g. In a meta-analysis comparing laparoscopy and vaginal hysterectomy, the total prevalence of perioperative complications according to the classification of Clavien and Dindo was 27%. For large uteruses, complications by the vaginal route amounted to 15% and those by the laparoscopic route to 37.5%.
The data are not sufficient to give preference to one or other of the approaches, but for benign pathologies, for large uteri (>280 g), the minimally invasive laparoscopic or vaginal approaches are recommended by the CNGOF (grade C).
A new Medical Device (MD), the vNOTES (Vaginal Natural Orifice Transluminal Endoscopy System) offers the advantage of two approaches for pelvic surgery by allowing minimally invasive surgery to be performed by endoscopy through the vagina, offering perfect vision for the assistants and the operator and without scarring. Two randomized trials have shown that vNOTES allows, compared to laparoscopy, to perform adnexectomies and hysterectomies without conversion with less pain, fewer postoperative complications and a shorter hospitalization time.
The first evaluations of vNOTES are encouraging and suggest a new era for pelvic surgery: less postoperative pain, fewer complications and facilitation of ambulatory care. Also the videoscopic assistance of the vNOTES is a pedagogical tool for the vaginal route because the field of vision is no longer limited to the operator alone. However, the vNOTES has only been evaluated by the developers of the tool, in monocentric studies and in small numbers. The hysterectomy study evaluated only 35 patients with vNOTES, half of whom had a uterus of less than 280 g. The benefit of vNOTES for uteri smaller than 280 g is not obvious because of the ease of the surgical procedure and the cost of the "classic" vaginal route. Our study would be the first multicentric and academic study on vNOTES to focus specifically on large volume uteri, the most difficult to operate and prone to postoperative complications.
調査の概要
状態
条件
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：Florence RANCON
- 電話番号：+33 0477829458
- メール：florence.rancon@chu-st-etienne.fr
研究連絡先のバックアップ
- 名前：Céline CHAULEUR, PhD
- 電話番号：+33 0477828383
- メール：celine.chauleur@chu-st-etienne.fr
研究場所
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-
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Bron、フランス、69677
- まだ募集していません
- HFME - Hospices Civils de Lyon
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主任研究者：
- Géry LAMBLIN
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コンタクト：
- Géry LAMBLIN
- メール：gery.lamlin@chu-lyon.fr
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Clermont-Ferrand、フランス、63003
- 募集
- CHU Clermont-Ferrand
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副調査官：
- Sandra CURINIER, PH
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コンタクト：
- Sandrine CAMPAGNE-LOISEAU, PH
- メール：scampagne-loiseau@chu-clermontferrand.fr
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主任研究者：
- Sandrine CAMPAGNE-LOISEAU, PH
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Issoire、フランス、63500
- まだ募集していません
- Ch Issoire
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コンタクト：
- Aslam MANSOOR
- メール：amansoor@ch-issoire.fr
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主任研究者：
- Aslam MANSOOR, PH
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Limoges、フランス、87042
- まだ募集していません
- CHU LIMOGES - Hôpital de la mère et de l'Enfant
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コンタクト：
- Tristan GAUTHIER, PhD
- 電話番号：+33 (0)5 55 05 61 64
- メール：tristan.gauthier@chu-limoges.fr
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Saint-Etienne、フランス、42100
- まだ募集していません
- Clinique Mutualiste de Saint-Etienne
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コンタクト：
- Quentin REBOUL, MD
- メール：quentinreboul@free.fr
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主任研究者：
- Quentin REBOUL, MD
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Saint-Etienne、フランス、42055
- まだ募集していません
- CHU Saint-Etienne
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コンタクト：
- Céline CHAULEUR, PhD
- 電話番号：0477828383
- メール：celine.chauleur@chu-st-etienne.fr
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主任研究者：
- Thomas CORSINI
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副調査官：
- Céline CHAULEUR
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副調査官：
- Ahamd MEDHI
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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:
- Any woman received in preoperative consultation in the Gynecology-Obstetrics Department for a benign pathology of a uterus estimated to be large requiring a hysterectomy.
- Patient affiliated or entitled to a social security system
- Patients over 18 years of age
- Patients having given their agreement to participate and after signing the consent form
Exclusion Criteria:
- Woman refusing to participate in the study (lack of consent)
- Non-French speaking woman (unable to conduct a good quality interview of the pregnant woman)
- Participation in another interventional study.
- Patient subject to a legal protection measure or unable to express her consent
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 |
|---|---|
|
アクティブコンパレータ：laparoscopic hysterectomy
Laparoscopic Hysterectomy will be performed in a standardized manner with or without surgical robot |
laparoscopic hysterectomy uses a standardized procedure with or without surgical robot |
|
実験的：natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES)
Vaginal hysterectomy will be performed in a standardized manner using transluminal endoscopic system |
hysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies) |
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 |
|---|---|---|
|
Proportion of patient with complications
時間枠：From surgery to 6 weeks of surgery
|
The proportion of patients with at least one pre- and post-operative complication at 6 weeks will be estimated along with its 95% confidence interval in each surgical strategy group. The primary endpoint is a composite endpoint including the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Postoperative complications were Infectious complications, Bleeding complications and All hospital readmissions related to the procedure Postoperative complications will be classified according to the Clavien-Dindo classification Intraoperative complications will be defined as :
|
From surgery to 6 weeks of surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Conversion
時間枠：During surgery
|
Number of patients with conversion during surgery |
During surgery
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post-operative pain
時間枠：From surgery to 3 hours of surgery
|
Maximal Pain measured by a numerical scale : 0 no pain / 10 maximum pain |
From surgery to 3 hours of surgery
|
|
Short-term postoperative pain
時間枠：From surgery to 1 week after surgery
|
Maximal short-term postoperative pain the first week after surgery measured by a numerical scale (0 no pain / 10 maximum pain) by a daily telephone call |
From surgery to 1 week after surgery
|
|
Duration of postoperative reflex ileus
時間枠：Day 0
|
Duration of post-operative reflex ileus between the day of the operation and the resumption of a transit (appearance of the first gas) in hours |
Day 0
|
|
Duration of the operation
時間枠：Surgery
|
operative time will be evaluated between the incision and the end of the closure, in minutes. |
Surgery
|
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Duration of hospitalization and the possibility of returning home
時間枠：last day of hospitalization
|
The length of hospital stay will be assessed in days and the possibility of return home by the time in hours from surgical incision to a Chung≥ score of 9/10. The Chung score assesses the possibility of a return home in ambulatory surgery. |
last day of hospitalization
|
|
Sexual dysfunction
時間枠：3 months
|
Sexual disorders: sexual life will be assessed by the difference in the specific validated score (self-questionnaire) (PISQ12 with a score ranging from 0 to 48) between the inclusion date and 3 months after surgery for sexually active women. |
3 months
|
協力者と研究者
捜査官
- 主任研究者：Céline CHAULEUR, PhD、Centre Hospitalier Universitaire de Saint Etienne
研究記録日
主要日程の研究
研究開始 (実際)
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
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