Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women (DISSUC)
The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.
Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.
調査の概要
状態
詳細な説明
Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.
This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.
Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.
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：Amr S. Hamza, Assoc. Prof.
- 電話番号：+41564863513
- メール：amr.hamza@ksb.ch
研究連絡先のバックアップ
- 名前：Leonhard Schaeffer, Prof.
- 電話番号：+41564863506
- メール：leonhard.schaeffer@ksb.ch
研究場所
-
-
Canton of Aargau
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Baden、Canton of Aargau、スイス、5400
- 募集
- Kantonsspital Baden
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コンタクト：
- Amr S. Hamza, Assoc. Prof.
- 電話番号：+41564863513
- メール：amr.hamza@ksb.ch
-
コンタクト：
- Leonhard Schaeffer, Prof.
- 電話番号：+41564863506
- メール：leonhard.schaeffer@ksb.ch
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Singleton, term pregnancy
- Elective cesarean section before labor onset or membrane rupture
- Maternal age >18 years
- Ability to provide informed consent
Exclusion Criteria:
- Placenta previa
- Maternal substance abuse or infection
- Suspected placenta accreta
- Diabetes
- one or more prior cesarean section
- Vulnerable participants (e.g., mental health conditions)
- Emergency cesarean sections
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Decidual Inclusion Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture.
All other operative steps will be performed according to the standardized study protocol.
|
During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health. |
|
実験的：Decidual Sparing Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture.
All other operative steps will be performed according to the standardized study protocol.
|
Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications. |
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 participants with a cesarean scar niche measured by ultrasound
時間枠：6 to 9 months post-operation
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Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound.
The outcome will be reported as the proportion of participants with a niche in each treatment group.
|
6 to 9 months post-operation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Residual-to-adjacent myometrial thickness ratio
時間枠：6 to 9 months post-operation
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Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
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6 to 9 months post-operation
|
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Operative time
時間枠：Periprocedural
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Operative time in minutes
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Periprocedural
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Need for additional sutures for hemostasis
時間枠：Periprocedural
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Need for additional hemostatic sutures, yes (how many: __ Number) /no
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Periprocedural
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Length of hospital stay
時間枠：Postoperative day 2
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Length of postoperative hospital stay in days
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Postoperative day 2
|
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Postoperative pain intensity on the 11-point Numeric Rating Scale
時間枠：Postoperative day 2
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Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Postoperative day 2
|
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Postoperative bleeding
時間枠：Postoperative day 2
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Clinically relevant postoperative bleeding, yes/no
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Postoperative day 2
|
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Wound infection
時間枠：Postoperative day 2
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Postoperative wound infection, yes/no
|
Postoperative day 2
|
|
Postoperative fever
時間枠：Postoperative day 2
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Postoperative fever, yes/no
|
Postoperative day 2
|
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Abnormal uterine bleeding
時間枠：6 to 9 months post-operation
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Abnormal uterine bleeding reported at follow-up, yes/no
|
6 to 9 months post-operation
|
|
Dysmenorrhea
時間枠：6 to 9 months post-operation
|
Dysmenorrhea reported at follow-up, yes/no
|
6 to 9 months post-operation
|
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Chronic pelvic pain
時間枠：6 to 9 months post-operation
|
Chronic pelvic pain reported at follow-up, yes/no
|
6 to 9 months post-operation
|
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Dyspareunia
時間枠：6 to 9 months post-operation
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Dyspareunia reported at follow-up, yes/no
|
6 to 9 months post-operation
|
|
Cesarean scar niche length measured by ultrasound in mm
時間枠：6 to 9 months post-operation
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Length of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
|
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Cesarean scar niche depth measured by ultrasound in mm
時間枠：6 to 9 months post-operation
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Depth of cesarean scar niche in mm measured by ultrasound.
|
6 to 9 months post-operation
|
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Cesarean scar niche width measured by ultrasound in mm
時間枠：6 to 9 months post-operation
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Width of cesarean scar niche in mm measured by ultrasound.
|
6 to 9 months post-operation
|
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Residual myometrial thickness measured by ultrasound in mm
時間枠：6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
|
6 to 9 months post-operation
|
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Presence of intrauterine fluid on ultrasound
時間枠：6 to 9 months post-operation
|
Presence or absence of intrauterine fluid on ultrasound.
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6 to 9 months post-operation
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Amr S. Hamza, Assoc. Prof.、Kantonsspital Baden
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
- StudyKSBHAM001
個々の参加者データ (IPD) の計画
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IPD プランの説明
医薬品およびデバイス情報、研究文書
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