Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
- Conditions
- Uterus AbnormalCesarean Section; DehiscenceUterine BleedingCesarean Section ComplicationsUterus; Scar
- Interventions
- Procedure: Hysterotomy closure
- Registration Number
- NCT06308172
- Brief Summary
The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups
- Detailed Description
Cesarean section, the most widely performed surgical procedure globally, has seen a significant increase in rates over the past decades, rising from 12.1% in 2000 to 21% in 2015 for various reasons. A recognized complication of cesarean sections is the formation of a uterine niche, commonly referred to as isthmocele. However, the true incidence of this post-operative complication remains uncertain, with reported figures ranging widely from 7% to 80%. The considerable variability in these estimates is attributed in part to the varying sensitivity of diagnostic tools. Moreover, there is a lack of consensus in the literature regarding the definition of a cesarean niche, particularly concerning the dimensions of the defect.
Recent well-designed randomized controlled trials have investigated the long-term outcomes of single versus double-layer hysterotomy closure during C-sections. These studies found no significant differences in isthmocele incidence or intermenstrual spotting. However, limitations such as the lack of correlation between symptom severity and uterine defect dimensions, the inclusion of women in labor, and relatively short follow-up periods are acknowledged weaknesses, prompting the need for further analysis.
Our objective is to compare the outcomes of single versus double-layer hysterotomy closure in terms of intermenstrual spotting and isthmocele incidence in singleton women undergoing elective C-sections. Crucially, standardizing the surgical suturing technique is essential to mitigate potential misleading outcomes resulting from inter-operator variations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- nulliparous
- singleton
- age 18-45
- spontaneous pregnancy or autologous assisted fertilization
- gestational age 38-40 weeks
- elective C-section
- informed consent
- coagulopathy
- autoimmune diseases
- gestational diabetes
- anticoagulant therapy
- immunosuppressive therapy
- endometriosis
- uterine fibromatosis
- spontaneous labour
- connective tissue diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-layer Hysterotomy closure Patients who are randomized in this arm undergo a single layer-hysterotomy closure Double-layer Hysterotomy closure Patients who are randomized in this arm undergo a double layer-hysterotomy closure
- Primary Outcome Measures
Name Time Method Intermenstrual bleeding reduction (days) 6 months The primary outcome of the study is to evaluate weather there is a reduction of intermenstrual bleeding in the six months after cesarean section among the two groups of patients.
- Secondary Outcome Measures
Name Time Method Intra-operatory time 6 months Evaluate evaluate weather there is a difference in operative time among the two groups of patients
Post-operatory recovery time 6 months Evaluate any difference in post-operative recovery time (days)
Time to full patient mobilization 6 months Evaluate any difference in post-operative time to full mobilization
Isthmocele 6 months Evaluate any difference in isthmocele incidence between the two groups
Blood loss 6 months Evaluate any difference in intra-operative blood loss (milliliters of blood)
Analgesics 6 months Evaluate any difference in post-operative use of analgesics
Trial Locations
- Locations (1)
Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
🇮🇹Milan, Mi, Italy