Suture method
ProcedureOne-layered Suture: Single layer intermittent suture; Two-layered Suture:Single layer intermittent suture plus U type reinforcement stitching
NCT Number: NCT05643703
Background and aims: Cesarean section defect (CSD) can cause abnormal uterine bleeding or impaired fertility, which severely impaire the quality of life in women of pregnant age. For women with moderate or severe CSD, surgery can be performed. The objectives of this study is to compare the efficacy and safety of different suture methods in the treatment of transvaginal diverticulum resection, and the underlying mechanism of CSD occurrence.
Methods: The patients diagnosed with CSD will be enrolled and randomizely assigned into suture method A and suture method. The fresh isolated tissue and swab of different sites in genital tract will be collected for NGS, microbiome, metabonomics and proteomics analysis.
Hypothesis: The menstruation will be analyzed at different following time. The other clinical information will be also collected, including age at surgery, skin-to skin operative time, estimated blood loss (EBL). The perioperative complications, postoperative hopitalization, cost for hospital stay, blasser/intestinal function recovery will also be compared between two gorup. The outcome of fertility will be compared, such as the premature birth, premature rupture of membranes, and rupture of uterus. The clinical manifestation related to CSD and recurrence will be followed. Besides, the underlying mechanism will be analyzed.
Trial opening soon.
Get Notified18 year–40 year
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One-layered Suture: Single layer intermittent suture; Two-layered Suture:Single layer intermittent suture plus U type reinforcement stitching
Time frame: 3 month after surgery
Patients' subject description of the duration of menstrual period, which is defined as the first day of menstruation to the end day
Time frame: within 5 years after surgery
record the post-operative fertility outcome, including natural pregnancy or assisted reproduction, and the correspondence fertility outcome, such as premature birth, premature rupture of membranes, etc.
Time frame: within 1 years after surgery
The difference of different diameters of caesarean scar diverticulum before and after surgery
Peking Union Medical College Hospital
Other
A Prospective Randomized Controlled Study on the Efficacy and Safety of Different Suture Methods for the Transvaginal Repair of Cesarean Section Defect and the Exploration of the Underlying Molecular Mechanism of the Defect Occurrence
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