Patients

Between Jun 11, 2012, and May 272,016, 228 Chinese women underwent vaginal repair for CSD at Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine. These women all had prolonged postmenstrual spotting and underwent treatment in our hospital. The research protocol was approved by the relevant Institutional Review Board before the study began. This study was approved by the Ethics Committee of Shanghai First Maternity and Infant Hospital, affiliated with Tongji University (KS1512), and was conducted in accordance with the Declaration of Helsinki.

We reviewed and collected the patients medical records and follow-up data after they provided informed consent. All participants gave written informed consent before the study began. The author(s) agreed to provide copies of the appropriate documentation if requested. Baseline clinicopathologic data, including delivery times, menstrual cycle, age, gravidity, parity, age at first C-section, number of C-sections, hemoglobin (Hb) and data from MRI imaging, were also recorded before surgery. Laboratory analysis of Hb was conducted via a regular blood test within 3days of surgery.

Patients treated by vaginal surgery were included in the study with the following criteria: 1) clinical features, such as longer menstruation after C-section and no significant change in the menstrual cycle; 2) history of C-section; and 3) CSD detected by MRI. Exclusion criteria included uterine pathologies, such as adenomyosis, leiomyoma and other conditions [21].

Each patient received continuous epidural anesthesia while in the lithotomy position. At a distance of 0.5cm below the site of the reflexed vesicocervical area,an anterior incision was made from the 3 oclock position to the 9 oclock position using an electric knife. The bladder was carefully dissected away from the uterus with sharp dissection scissors toward the abdominal cavity until the peritoneum was reached. Once the abdominal cavity was entered and the cervical and lower uterine segments were exposed. The CSD tissue was cut to the normal healthy muscle. The incision was closed with a double layer of 10 absorbable interrupted sutures. After adequate hemostasis, the peritoneum and bilateral bladder column were sutured, followed by the incision in the cervical vaginal area.

Patients included in the study had follow-up clinic visits to record their menstruation at 1, 3 and more than 6months after the procedure and measure the CSD scar site by MRI at more than 6months after the procedure. According to the previous study, patients menstruation would likely plateau at follow-up visits more than 3months after surgery [21]. The data from MRI were evaluated at the same center by an experienced radiologist. The data after surgery mainly included the number of menstruation days and the depth, length, width, and thickness of the remaining muscular layer (TRM) as well as the depth/ TRM ratio based on contrast-enhanced MRI [21](Fig. 1). Primary outcomes were the number of postmenstrual spotting days and depth/ TRM ratio. All events and any modifications that occurred during follow-up were recorded.

We defined the Class-A healing group as CSD patients who had menstruation duration of no more than 7days and a thickness of the remaining muscular layer of no less than 5.8mm after vaginal repair, and all other patients were included in the non-class-A healing group [28].

Patient characteristics and preoperative factors were analyzed using students t test and chi-square tests. Ages are given as the medians with ranges, others variables are expressed as meanSD. Multivariate logistic regression models were used to assess risk factors associated with non-class-A healing of CSD. Regression coefficients were used to generate prognostic nomograms. Model discrimination was measured quantitatively with the concordance index. Internal validation was performed using 1000 bootstrap resampling to quantify the overfitting of our modeling strategy and predict future performance of the model.

We incorporated both the depth/TRM ratio measured by MRI and clinical factors into a personalized nomogram for facilitating preoperative prediction of non-class-A healing in CSD patients. Multimarker analyses have been used in recent years for incorporating individual factors into marker panels [29].

All statistical analyses were performed by R software (version 3.3.2). The statistical significance levels were two-sided, with a P value of .05 or less.

Multivariable logistic regression analysis was used to assess the individualized prediction model with the following clinical candidate factors taken before surgery: the depth/ TRM ratio via MRI, number of menstruation days after C-section, WBC and fibrinogen. We built the final nomogram based on logistic regression analysis in the training cohort.

A calibration curve was plotted to evaluate the calibration of the nomogram using the Hosmer-Lemeshow test. A significant test statistic indicated that the prediction model did not calibrate perfectly [30]. Harrells C-index was computed to quantify the performance of the nomogram.

Internal validation was carried out using data from 167 patients.

Decision curve analysis was performed to determine the clinical usefulness of the nomogram by quantifying the net benefits at different threshold probabilities.

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Development and internal validation of a Nomogram for preoperative prediction of surgical treatment effect on cesarean section diverticulum - BMC...

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