To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial
調査の概要
状態
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：Dabao MD
- 電話番号：13017386201
- メール：forxudabao@126.com
研究場所
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Hunan
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Changsha、Hunan、中国、410013
- 募集
- The Third XIANGYA Hospital of Central South University
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コンタクト：
- Dabao MD
- 電話番号：13017386201
- メール：forxudabao@126.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients clinically diagnosed with intrauterine adhesions and with surgical indications (referring to those with fertility requirements or obstructed menstrual blood drainage) ② Women aged 20-40 years old; ③ Subjects voluntarily participated in the trial and signed informed consent.
Exclusion Criteria:
① Patients with obviously abnormal uterine cavity shape after surgery; those who could not clearly separate the normal uterine cavity anatomical morphology (i.e. bilateral or unilateral fallopian tube openings were not visible); those with reproductive organ malformations and uterine cavities that were too large or too small; those with recent uterine perforation; those with cervical insufficiency.
Those with a history of intrauterine adhesions and treatment;
Those with endometrial tuberculosis or suspected endometrial tuberculosis;
Those with adenomyosis or uterine fibroids>4cm;
Those with a history of malignant tumors or suspected malignant tumors;
Those with acute and chronic intrauterine infection and genital infection;
Those with unexplained vaginal bleeding or suspected uterine malignant lesions;
Those with severe anemia and abnormal coagulation function; those with a history of thrombosis; ⑨ Those in the acute stage of various diseases or severe systemic diseases;
Those with severe mental illness and physical weakness who cannot tolerate this operation;
⑪ Those with severe heart, liver, and kidney function diseases;
⑫ Those with contraindications to anesthesia or surgery;
⑬ Those who have participated in clinical trials in the past three months.
- Those who are considered unsuitable for inclusion by the researchers.
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 |
|---|---|
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実験的：Experimental group
Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery
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After TCRA, uterine stents of different specifications were placed in the uterine cavity according to the different uterine cavity morphologies of the subjects, and the hysteroscope was inserted again to adjust the position of the uterine stent.
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実験的：Control group
Uterine cavity insertion ring + balloon + sodium hyaluronate gel
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The subjects were hospitalized for TCRA surgery.
After the surgery, different types of uterine rings were selected and inserted into the uterine cavity according to the morphology of the subjects' uterine cavity.
At the same time, a No. 12 Foley catheter was left in the uterine cavity, and 2.5 ml of normal saline was injected into the catheter balloon. 2 ml of hyaluronic acid gel was injected into the uterine cavity on one side of the catheter.
The doctor removed the Foley catheter on the first day after the surgery.
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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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Intrauterine adhesion rate
時間枠：At 12 months after the index hysterectomy
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Refer to the 2017 American Fertility Association IUA guidelines AFS score.
AFS score: The case with adhesion whose total AFS score decreased by ≥ 4 points was considered effective.
The effective rate was calculated using the following formula: number of cases with total AFS score decreased by ≥ 4 points/total number of cases × 100%.
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At 12 months after the index hysterectomy
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協力者と研究者
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
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
- XY3-QX-ZGZ-1711A02
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
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。