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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Amr S. Hamza, Assoc. Prof.
- Número de telefone: +41564863513
- E-mail: amr.hamza@ksb.ch
Estude backup de contato
- Nome: Leonhard Schaeffer, Prof.
- Número de telefone: +41564863506
- E-mail: leonhard.schaeffer@ksb.ch
Locais de estudo
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Canton of Aargau
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Baden, Canton of Aargau, Suíça, 5400
- Recrutamento
- Kantonsspital Baden
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Contato:
- Amr S. Hamza, Assoc. Prof.
- Número de telefone: +41564863513
- E-mail: amr.hamza@ksb.ch
-
Contato:
- Leonhard Schaeffer, Prof.
- Número de telefone: +41564863506
- E-mail: leonhard.schaeffer@ksb.ch
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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. |
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Experimental: 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.
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with a cesarean scar niche measured by ultrasound
Prazo: 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.
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6 to 9 months post-operation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Residual-to-adjacent myometrial thickness ratio
Prazo: 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
Prazo: Periprocedural
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Operative time in minutes
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Periprocedural
|
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Need for additional sutures for hemostasis
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Postoperative day 2
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Postoperative wound infection, yes/no
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Postoperative day 2
|
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Postoperative fever
Prazo: Postoperative day 2
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Postoperative fever, yes/no
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Postoperative day 2
|
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Abnormal uterine bleeding
Prazo: 6 to 9 months post-operation
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Abnormal uterine bleeding reported at follow-up, yes/no
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6 to 9 months post-operation
|
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Dysmenorrhea
Prazo: 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
Prazo: 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
Prazo: 6 to 9 months post-operation
|
Dyspareunia reported at follow-up, yes/no
|
6 to 9 months post-operation
|
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Cesarean scar niche length measured by ultrasound in mm
Prazo: 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
Prazo: 6 to 9 months post-operation
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Depth 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 width measured by ultrasound in mm
Prazo: 6 to 9 months post-operation
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Width of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
Prazo: 6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
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6 to 9 months post-operation
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Presence of intrauterine fluid on ultrasound
Prazo: 6 to 9 months post-operation
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Presence or absence of intrauterine fluid on ultrasound.
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6 to 9 months post-operation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amr S. Hamza, Assoc. Prof., Kantonsspital Baden
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Transtornos Mentais, Desordem Mental
- Doenças Genitais, Masculino
- Doenças Urogenitais Masculinas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Genitais Femininas
- Disfunção Sexual Fisiológica
- Disfunções Sexuais, Psicológicas
- Dispareunia
Outros números de identificação do estudo
- StudyKSBHAM001
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