Cesarean Section Complications, Cesarean Section; Dehiscence, Uterine Bleeding, Uterus Abnormal, Uterus; Scar
Conditions
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.
Interventions
PROCEDUREHysterotomy closure
Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Patients are recruited and randomly assigned to either the single-layer or double-layer arm of the study. The randomization process occurs on the day of the cesarean section. Following randomization, patients are informed about their assigned group, and the cesarean section procedure is then carried out.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* nulliparous * singleton * age 18-45 * spontaneous pregnancy or autologous assisted fertilization * gestational age 38-40 weeks * elective C-section * informed consent
Exclusion criteria
* coagulopathy * autoimmune diseases * gestational diabetes * anticoagulant therapy * immunosuppressive therapy * endometriosis * uterine fibromatosis * spontaneous labour * connective tissue diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Intra-operatory time | 6 months | Evaluate evaluate weather there is a difference in operative time among the two groups of patients |
| 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 |
| Post-operatory recovery time | 6 months | Evaluate any difference in post-operative recovery time (days) |
Countries
Italy
Contacts
Primary ContactGiuseppe Perugino, MD
Outcome results
None listed