Dataset Information

The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study.

ABSTRACT:

Objective

To evaluate the effectiveness of a laparoscopic niche resection on niche-related symptoms and/or fertility-related problems, ultrasound findings and quality of life.

Design

Prospective cohort study.

Setting

University hospital.

Population

Women with a large niche (residual myometrium <3 mm) and complaints of either postmenstrual spotting, dysmenorrhoea, intrauterine fluid accumulation and/or difficulties with embryo transfer due to distorted anatomy.

Methods

Women filled out questionnaires and a validated menstrual score chart at baseline and 6 months after the laparoscopic niche resection. At baseline and between 3 and 6 months follow up niches were evaluated by transvaginal ultrasound.

Main outcome measures

The primary outcome was reduction of the main problem 6 months after the intervention. Secondary outcomes were complications, menstrual characteristics, dysmenorrhoea, niche measurements, intrauterine fluid, surgical outcomes, satisfaction and quality of life.

Results

In all, 101 women underwent a laparoscopic niche resection. In 80 women (79.2%) the main problem was improved or resolved. Postmenstrual spotting was significantly reduced by 7 days at 6 months follow up compared with baseline. Dysmenorrhoea and discomfort related to spotting was also significantly reduced. The residual myometrium was increased significantly at follow up. The intrauterine fluid was resolved in 86.9% of the women with intrauterine fluid at baseline; 83.3% of women were (very) satisfied. The physical component of quality of life increased, the mental component did not change.

Conclusions

A laparoscopic niche resection reduced postmenstrual spotting, discomfort due to spotting, dysmenorrhoea and the presence of intrauterine fluid in the majority of women and increased the residual myometrium.

Tweetable abstract

Laparoscopic niche resection reduces niche-related problems and enlarges the residual myometrium.

SUBMITTER: Vervoort A

PROVIDER: S-EPMC5811817 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Publications

The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study.

Vervoort Ajmw A Vissers J J Hehenkamp Wjk W Brölmann Ham H Huirne Jaf J

BJOG : an international journal of obstetrics and gynaecology 20170828 3

<h4>Objective</h4>To evaluate the effectiveness of a laparoscopic niche resection on niche-related symptoms and/or fertility-related problems, ultrasound findings and quality of life.<h4>Design</h4>Prospective cohort study.<h4>Setting</h4>University hospital.<h4>Population</h4>Women with a large niche (residual myometrium <3 mm) and complaints of either postmenstrual spotting, dysmenorrhoea, intrauterine fluid accumulation and/or difficulties with embryo transfer due to distorted anatomy.<h4>Met ...[more]

PMID: 28703935

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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:IntroductionAfter incomplete healing of the uterine cesarean section scar, a niche can be observed; 24% of the women develop large niches with a residual myometrial thickness <3 mm. In these cases a laparoscopic resection is possible. The effect of this new treatment on fertility outcome is not known yet. This paper describes reproductive outcomes 2 years after a laparoscopic niche resection and compares women with or without secondary infertility at baseline.Material and methodsA prospective cohort study was performed, with consecutive inclusion of women between 2011 and 2019. Women with a niche in the uterine cesarean scar, with a residual myometrial thickness of <3 mm and with a desire to become pregnant, were scheduled to undergo a laparoscopic niche resection because of one or more of the following problems (1) postmenstrual spotting; (2) midcycle intrauterine fluid accumulation diagnosed during the fertility workup or (3) difficulties with a previous embryo transfer and preferring a surgical therapy. The study is registered in the ISRCTN register (ref. no. ISRCTN02271575) on April 23, 2013.ResultsThere were 133 (62%) women included with a desire to become pregnant, 88 with secondary infertility. In all, 83 had an ongoing pregnancy at the 2-year follow-up. The ongoing pregnancy rate in patients with previous fertility problems was 60.2% compared with 66.7% in patients without infertility (odds ratio [OR] 0.68, 95% confidence interval [CI] 0.32-1.7). The OR for live births was 0.57 (95% CI 0.02-1.2). Overall, 8.3% of the pregnancies resulted in miscarriages by the 2-year follow-up.ConclusionsThe reproductive outcomes in women with and without previous fertility problems undergoing resection of a large niche are very promising and quite comparable in both groups. These results suggest, but do not prove, a beneficial effect of this therapy for these indications. The results support the design of future randomized controlled trials to evaluate the effect of niche resection vs expectant management to assess its additional value in women with or without fertility problems who desire pregnancy.

Project description:BackgroundDouble-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility.MethodsWomen undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective.DiscussionThis RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound.Trial registrationDutch Trial Register ( NTR5480 ). Registered 29 October 2015.

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.

Dataset Information

The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study.

Objective

Design

Setting

Population

Methods

Main outcome measures

Results

Conclusions

Tweetable abstract

Publications

The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study.

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