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Effectiveness of hysteroscopic resection of a uterine caesarean niche can be predicted: a prospective cohort study.

ABSTRACT: This study aimed to develop and validate a model for the preoperative prediction of the effectiveness of hysteroscopic resection of a uterine cesarean niche in patients with postmenstrual spotting. The predictive model was developed in a primary prospective cohort consisting of 208 patients with niche treated by hysteroscopic resection. Multivariable logistic regression analysis was performed to develop the predictive model, which incorporated preoperative menstrual characteristics and magnetic resonance imaging (MRI) findings. Surgical efficacy was defined as a decrease in postmenstrual spotting duration of at least 3 days at the 3-month follow-up compared with baseline. The predictive model was presented with a nomogram, and the performance was assessed with respect to its calibration, discrimination, and clinical use. Internal validation was performed using tenfold cross-validation. The predictive factors in the final model were as follows: preoperative menstrual duration, thickness of the residual myometrium (TRM), length, TRM/thickness of the adjacent myometrium ratio, angle ?, area, and presence of a lateral branch of the niche. The model showed good performance in predicting the effectiveness of hysteroscopic niche resection. Incorporating the preoperative duration of the menstrual period and MRI findings of the niche into an easy-to-use nomogram facilitates the individualized prediction of the effectiveness of a hysteroscopic niche resection by 26 Fr resectoscope, but multicenter prospective studies are needed to validate it.

SUBMITTER: Zhu Q

PROVIDER: S-EPMC7566491 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of hysteroscopic resection of a uterine caesarean niche can be predicted: a prospective cohort study.

Zhu Qian Q He Xiaoqing X Jiang Ling L Liang Guiling G Zhu Chenfeng C Pan Hongjie H Zhang Jian J Huirne Judith Anna JA

Scientific reports 20201015 1

This study aimed to develop and validate a model for the preoperative prediction of the effectiveness of hysteroscopic resection of a uterine cesarean niche in patients with postmenstrual spotting. The predictive model was developed in a primary prospective cohort consisting of 208 patients with niche treated by hysteroscopic resection. Multivariable logistic regression analysis was performed to develop the predictive model, which incorporated preoperative menstrual characteristics and magnetic ...[more]

PMID: 33060690

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Project description:IntroductionA uterine niche is a defect at the site of the uterine caesarean scar that is associated with gynaecological symptoms and infertility. Promising results are reported in cohort studies after a laparoscopic niche resection concerning reduction of gynaecological symptoms in relation to baseline and concerning pregnancy outcomes. However, randomised controlled trials to study the effect of a laparoscopic niche resection on reproductive outcomes in infertile women are lacking. This study will answer the question if laparoscopic niche resection in comparison to expectant management improves reproductive outcomes in infertile women with a large uterine niche.Methods and analysisThe LAPRES study is a randomised, non-blinded, controlled trial, including 200 infertile women with a total follow-up of 2 years. Women with the presence of a large niche in the uterine caesarean scar and unexplained infertility of at least 1 year or failed IVF will be randomly allocated to a laparoscopic niche resection within 6 weeks or to expectant management for at least 9 months. A large niche is defined as a niche with a depth of >50% of the myometrial thickness and a residual myometrium of ≤3 mm on transvaginal ultrasound. Those receiving expectant management will be allowed to receive fertility therapies, including assisted reproductive techniques, if indicated. The primary outcome is time to ongoing pregnancy, defined as a viable intrauterine pregnancy at 12 weeks' gestation. Secondary outcome measures are time to conception leading to a live birth, other pregnancy outcomes, received fertility therapies after randomisation, menstruation characteristics, patient satisfaction, quality of life, additional interventions, and surgical and ultrasound outcomes (intervention group). Questionnaires will be filled out at baseline, 6, 12 and 24 months after randomisation. Ultrasound evaluation will be performed at baseline and at 3 months after surgery.Ethics and disseminationThe study protocol was approved by the medical ethics committee of the Amsterdam University Medical Centre. (Ref. No. 2017.030). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication. TRIAL REGISTRATION NUMBER DUTCH TRIAL REGISTER REF NO NL6350 : http://www.trialregister.nl.

Project description:IntroductionRecently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting, it has not been studied if the effect of levonorgestrel 52 mg intrauterine system (LNG-IUS 52 mg) is superior to that of hysteroscopy. This study will answer the question of whether LNG-IUS 52 mg is more effective in improving postmenstrual spotting than hysteroscopic niche resection in women with niche-related spotting at 6 months after randomisation.Methods and analysisThis is a randomised controlled trial. A total of 208 women with postmenstrual spotting related to niche in the caesarean uterine scar of at least 2 mm and residual myometrium of at least 2.2 mm evaluated by MRI will be included. Women desiring to conceive within 1 year, with contraindications for LNG-IUS 52 mg or hysteroscopic surgery will be excluded. After informed consent is obtained, eligible women will be randomly allocated to LNG-IUS 52 mg or hysteroscopic niche resection at 1:1. The primary outcome is the efficacy in reducing postmenstrual spotting at 6 months after randomisation. The secondary outcomes include menstrual pattern, total days of blood loss per month, rate of amenorrhoea, side effects and complications.We will use a Visual Analogue Scale for chronic pelvic pain, urological symptoms and women's satisfaction (five-point Likert scale).Ethics and disseminationThe study was approved by the local medical ethics committee and by the Institutional Review Board of the International Peace Maternity and Child Health Hospital, Shanghai, China (No. GKLW 2019-08). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.Trial registration numberChiCTR1900025677.

Project description:BackgroundCaesarean scar pregnancy (CSP) is a type of ectopic pregnancy where the fertilised egg is implanted in the muscle or fibrous tissue of the scar after a previous caesarean section. Management options for women who opted for termination of CSP include sharp curettage, dilation and evacuation (D&E), excision of trophoblastic tissues, local or systemic administration of methotrexate, bilateral hypogastric artery ligation, and selective uterine artery embolisation with curettage and/or methotrexate administration. Recently hysteroscopic resection has also been proposed as an alternative option.ObjectiveTo compare the surgical outcome of hysteroscopic resection with dilation and evacuation (D&E) for the treatment of caesarean scar pregnancy (CSP).MethodsParallel-group, non-blinded, randomised clinical trial conducted at a single centre in Italy. Eligible women are those with singleton gestations at less than 9 weeks of gestation, and with thickness of myometrial layer ≥1 mm at the level of the ectopic. Inclusion criteria are women with CSP with positive embryonic/fetal heart activity who opted for termination of pregnancy. Patients will be randomised 1:1 to receive either hysteroscopic resection (i.e. intervention group) or D&E (i.e. control group). In both groups, 50 mg/m2 (based on DuBois formula for body surface area) of methotrexate (MTX) will be injected intramuscularly at the time of randomisation (day 1) and another dose at day 3. A third dose of MTX is planned in case of persistence of fetal heart activity on day 5. Participants will receive either D&E or hysteroscopic resection from 3 to 7 days after the last dose of MTX. A sample size of 54 women is planned.Main outcome measuresThe primary outcome is the success rate of the treatment protocol, defined as no requirement for further treatment until complete resolution of the CSP as demonstrated by negative beta hCG levels and absence of residual gestational material on ultrasound examination..Study hypothesisHysteroscopic surgery is superior to D&E for the treatment of CSP.What is new?The results of the trial will provide information on the best treatment for CSP.

Project description:ObjectiveTo evaluate the clinical effectiveness and pregnancy rate after hysteroscopic resection (HR) and/or vaginal repair (VR) in patients with cesarean scar defect (CSD).MethodsThis prospective observational study enrolled 191 patients who received CSD surgery in the First affiliated hospital of Sun Yat-sen University between September 2019 to February 2022 (96 in HR and 95 in VR, respectively). Patient follow-up were performed three months after surgery in both groups by transvaginal ultrasound to confirm the presence of fluid in the niche, along with the resolution of prolonged menses at the same time. The primary outcome was the clinical effectiveness between HR and VR, identified by the resolution of prolonged menses.ResultsThe rates of niche-fluid disappearance (70.1% vs 60.2%, P = 0.176) and prolonged menses resolution (74.8% vs 80.0%, P = 0.341) were comparable for HR and VR. A subgroup analysis for niche size revealed that HR provides patients with small niche a more favorable rate of menstrual resolution compared to VR (size of niche ≤ 15 mm2, aOR = 3.423, 95% confidence interval [CI] 1.073-10.918), but patients with large niche experience a lower rate of resolution compared to VR (size of niche > 25 mm2, aOR = 0.286, 95% CI 0.087- 0.938). During follow-up, 41 patients who wanted to conceive became pregnant. Kaplan-Meier estimates of the cumulative probability of pregnancy at 12 months and 24 months were 47.1% (95% CI: 34.5%, 58.8%) and 63.8% (95% CI: 52.5%, 72.9%), respectively. The median pregnancy time was 22 months (95% CI: 14.2, 29.8) after VR and 12 months (95% CI: 8.3, 15.7, Gehan-Breslow-Wilcoxon P = 0.021) after HR. Among patients with subsequent infertility, 31.6% achieved pregnancy by unassisted mode and 29.8% by IVF/ICSI. Moreover, among patients with previously failed IVF/ICSI treatment, 60% (12/20) obtained pregnancy, including 71.4% (10/14) after HR and 33.3% (2/6) after VR.ConclusionsHysteroscopic resection is as effective as vaginal repair at relieving symptoms of CSD-associated prolonged menses. Hysteroscopic resection is the modality of choice with an improvement in prolonged menses for small niche, while vaginal might be considered for a large niche. Furthermore, surgical intervention could improve the clinical pregnancy rate of CSD patients. All of these provide evidence for the individualized management of CSD.

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Effectiveness of hysteroscopic resection of a uterine caesarean niche can be predicted: a prospective cohort study.

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Effectiveness of hysteroscopic resection of a uterine caesarean niche can be predicted: a prospective cohort study.

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