Review and meta-analysis of prospective randomized controlled trials (RCTs) comparing laparo-endoscopic single site and multiport laparoscopy in gynecologic operative procedures.

PURPOSE: To critically appraise published randomized controlled trials (RCTs) comparing laparo-endoscopic single site (LESS) and multi-port laparoscopic (MPL) in gynecologic operative surgery; the aim was to assess feasibility, safety, and potential benefits of LESS in comparison to MPL. METHODS: A systematic review and meta-analysis of eleven RCTs. Women undergoing operative LESS and MPL gynecologic procedure (hysterectomy, cystectomy, salpingectomy, salpingo-oophorectomy, myomectomy). Outcomes evaluated were as follows: postoperative overall morbidity, postoperative pain evaluation at 6, 12, 24 and 48 h, cosmetic patient satisfaction, conversion rate, body mass index (BMI), operative time, blood loss, hemoglobin drop, postoperative hospital stay. RESULTS: Eleven RCTs comprising 956 women with gynecologic surgical disease randomized to either LESS (477) or MPL procedures (479) were analyzed systematically. The LESS approach is a surgical procedure with longer operative and better cosmetic results time than MPL but without statistical significance. Operative outcomes, postoperative recovery, postoperative morbidity and patient satisfaction are similar in LESS and MPL. CONCLUSION: LESS may be considered an alternative to MPL with comparable feasibility and safety in gynecologic operative procedures. However, it does not offer the expected advantages in terms of postoperative pain and cosmetic satisfaction.

Endometrial ablation: first- vs. second-generation techniques.

INTRODUCTION: Endometrial ablation is a procedure that surgically destroys (ablates) the lining of the uterus (endometrium). The goal of endometrial ablation is to reduce menstrual flow. In some women, menstrual flow may stop completely. In some cases, endometrial ablation may be an alternative to hysterectomy. There are several techniques used to perform endometrial ablation, including electrical or electrocautery ablation, in which an electric current travels through a wire loop or rollerball is applied to the endometrial lining to cauterize the tissue; hydrothermal ablation, in which heated fluid is pumped into the uterus and destroys the endometrial lining via high temperatures; balloon therapy ablation, in which a balloon at the end of a catheter is inserted into the uterus and filled with fluid, which is then heated to the point that the endometrial tissues are eroded away; radiofrequency ablation in which a triangular mesh electrode is expanded to fill the uterine cavity, at which point the electrode delivers an electrical current and destroys the endometrial lining; cryoablation (freezing), in which a probe uses extremely low temperatures to freeze and destroy the endometrial tissues; and microwave ablation, in which microwave energy is delivered through a slender probe inserted into the uterus and destroys the endometrial lining. EVIDENCE ACQUISITION: The purpose of this systematic review was to evaluate the feasibility, safety, and efficacy of endometrial ablation performed with first- and second-generation techniques. A literature search in PubMed from January 2000 to September 2015 was performed using the keywords endometrial ablation, menorrhagia, and heavy menstrual bleeding. Results were restricted to systematic reviews, randomized control trials (RCT)/controlled clinical trials, and observational studies written in English from January 2000 to September 2015. EVIDENCE SYNTHESIS: There is no evidence that either broad category is more effective than the other in reducing HMB, and there is no evidence that rates of satisfaction differ significantly. CONCLUSIONS: The overall results of the presented studies suggest that endometrial ablation is an effective therapy for menorrhagia in women with bleeding disorders.

Focusing on surgery results in infertile patients with deep endometriosis.

Infertility is a common problem in patients with endometriosis and the involved mechanisms are still not completely known. The management of infertility in endometriosis patients includes surgery as well as assisted reproductive technology. Laparoscopic surgery has shown better results in infertility patients with endometriosis in comparison to laparotomy procedures. Laparoscopic surgery has proposed benefits in both minimal to moderate diseases. However, while there may be some benefits with severe diseases, there is still not enough evidence to recommend laparoscopic surgery as the recommended surgery when the main goal is to obtain fertility. We performed a MEDLINE search for articles on fertility in women with deep infiltrating endometriosis (DIE) published between 1990 and April 2015 using the following keywords: "endometriosis", "deep infiltrative endometriosis", "infertility", "fertility after surgery", "laparoscopy surgery", "laparotomy", "pregnancy", "fertility outcome", "bladder endometriosis", and "ureteral endometriosis". The aim of this review was to analyze the results of available clinical studies (randomized controlled or not controlled studies; retrospective cohort studies; or case-control and prospective studies) and guidelines on surgical treatment of infertile endometriosis patients, and pregnancy outcomes after surgery.

Surgical technique of endometrioma excision impacts on the ovarian reserve. Single-port access laparoscopy versus multiport access laparoscopy: a case control study.

Several recent studies report the detrimental effect of endometrioma excision on the ovarian reserve. Surgical technique and the excessive use of bipolar coagulation could be the key factors. Single-port access laparoscopy (SPAL) ovarian cystectomy has been reported as a comparable procedure to conventional laparoscopy in terms of operative outcomes. The aim of this study was to evaluate whether the single-port surgery affects the ovarian reserve whilst performing laparoscopic ovarian cystectomy for unilateral endometrioma. This was a prospective, case-control study of 99 women with unilateral endometrioma. Forty-nine women underwent single-port cystectomy and 50 women underwent multiport laparoscopic (MPL) conventional cystectomy. The primary outcome was the assessment of the ovarian reserve. We evaluated the serum anti-Mullerian hormone (AMH) levels before, 4-6 weeks and 3 months after surgery. At T2 we performed an ultrasound assessment of the antral follicular count (AFC). We have drawn attention to a statistically significant decrease of the mean AMH value and AFC in the SPAL group at the 4-6-week and 3-month follow-up compared to the conventional laparoscopy group. In conclusion, our results suggest that SPAL cystectomy should not be recommended to patients undergoing surgery for endometrioma excision who want to preserve their fertility.

Single-port versus conventional multiport access prophylactic laparoscopic bilateral salpingo-oophorectomy in high-risk patients for ovarian cancer: a comparison of surgical outcomes.

Bilateral salpingo-oophorectomy (BSO) in carriers of BRCA1 and BRCA2 mutations is widely recommended as part of a risk-reduction strategy for ovarian or breast cancer due to an underlying genetic predisposition. BSO is also performed as a therapeutic intervention for patients with hormone-positive premenopausal breast cancer. BSO may be performed via a minimally invasive approach with the use of three to four 5 mm and/or 12 mm ports inserted through a skin incision. To further reduce the morbidity associated with the placement of multiple port sites and to improve cosmetic outcomes, single-port laparoscopy has been developed with a single access point from the umbilicus. The purpose of this study was to evaluate the surgical outcomes associated with reducing the risks of salpingo-oophorectomy performed in a single port, while comparing multiport laparoscopy in women with a high risk for ovarian cancer. Single-port laparoscopy-BSO is feasible and safe, with favorable surgical and cosmetic outcomes when compared to conventional laparoscopy.

Past, present and future ultrasonographic techniques for analyzing ovarian masses.

Ultrasonography is today the method of choice for distinguishing between benign and malignant adnexal pathologies. Using pattern recognition several types of tumors can be recognized according to their characteristic appearance on gray-scale imaging. Color Doppler imaging should be used only to perform a semiquantitative color score or evaluate the flow location. International Ovarian Tumor Analysis group had standardized definitions characterizing adnexal masses and suggested the use of 'simple rules' in premenopausal women. Recently, the use of 3D vascular indices has been proposed but its potential use in clinical practice is debated. Also computerized aided diagnosis algorithms showed encouraging results to be confirmed in the future.

Dienogest. A possible conservative approach in bladder endometriosis. Results of a pilot study.

Deep endometriosis involvement of the bladder is uncommon but it is symptomatic in most of the cases. Although laparoscopic excision is very effective, some patients with no pregnancy desire require a medical approach. We performed a pilot study on the effect of a new progestin dienogest on bladder endometriosis. Six patients were treated for 12 months with dienogest 2 mg/daily. Pain, urinary symptoms, quality of life, nodule volume and side effects were recorded. During treatment, symptoms improved very quickly and the nodules exhibit a remarkable reduction in size. Dienogest may be an alternative approach to bladder endometriosis.

Reproducibility of two different methods for performing mean gray value evaluation of cyst content in endometriomas using VOCAL.

OBJECTIVE: To compare two different methods (manual sampling of the entire cyst and semi-automated spherical sampling from the central part of the cyst) for calculating the mean gray value (MGV) from the cystic content in endometriomas using virtual organ computer-aided analysis (VOCAL). METHODS: Forty-one volumes from histologically confirmed endometriomas were retrieved from our database and the volumes were analyzed to compare the MGVs obtained via the two modalities. In addition, to evaluate the reproducibility in a sample of 20 volumes, two different observers calculated the MGV from cyst content using VOCAL software. For each method, each examiner analyzed the volumes twice, 3 weeks apart, for assessment of intra-observer agreement. First, manual sampling of the internal contour of all the cysts was performed, and 1 week later semi-automated 2-cm sphere sampling from the central part of the cyst was carried out. In addition, the observers recorded the time spent performing each analysis. Inter- and intra-observer reproducibility was evaluated for each method using intra-class correlation coefficients (ICC). RESULTS: There was no difference in the mean MGV between manual sampling (22.211 ± 7.541) and the semi-automated modality of sampling (23.840 ± 8.621, p = 0.439). The correlation between manual and semi-automated sampling measurement was high (r = 0.92). According to the ICCs, there was no significant difference in interobserver reliability between manual sampling (0.931; 95 % CI, 0.824-0.973) and the semi-automated modality of sampling (0.924; 95 % CI, 0.809-0.970). Intra-observer reproducibility for both examiners was good (ICC > 0.94). Semi-automated measurements were obtained faster than those obtained by manual evaluation (p = 0.0001 for observer 1 and p = 0.083 for observer 2). CONCLUSIONS: Both methods seem to be reliable, but the semi-automated method using the sphere should be preferred because it is a less time-consuming procedure.

Assessing the reproducibility of the IOTA simple ultrasound rules for classifying adnexal masses as benign or malignant using stored 3D volumes.

OBJECTIVE: To analyze the reproducibility of the IOTA simple ultrasound rules for classifying adnexal masses as benign or malignant among examiners with different level of expertise using stored 3D volumes of adnexal masses. STUDY DESIGN: Five examiners, with different levels of experience and blinded to each other, evaluated 100 stored 3D volumes from adnexal masses and looked for the presence or absence of malignant or benign features according to the IOTA definitions. Multiplanar view and virtual navigation were used. All examiners had to assess the 3D volume of each adnexal mass and classify it as benign or malignant. To analyze intra-observer agreement each examiner performed the assessment twice with a two-week interval between the first and second assessments. To analyze the inter-observer agreement, the second assessment from each examiner was used. Reproducibility was assessed calculating the weighted Kappa index. RESULTS: Intra-observer reproducibility was moderate or good for all observers (Kappa index ranging from 0.59 to 0.74). Inter-observer reproducibility was moderate to good (Kappa index range: 0.46-0.67). CONCLUSIONS: The simple rules are reasonably reproducible among observers with different level of expertise when assessed in stored 3D volumes.

Three-dimensional volume off-line analysis as compared to real-time ultrasound for assessing adnexal masses.

OBJECTIVE: To assess the agreement between three-dimensional volume off-line analysis as compared to real-time ultrasound for assessing adnexal masses. STUDY DESIGN: Ninety-nine non-consecutive women diagnosed as having an adnexal mass were assessed by transvaginal power Doppler ultrasound. One single examiner performed all ultrasound examinations. Based on the examiner's subjective evaluation using gray scale and Doppler ultrasound findings a presumptive diagnosis (benign or malignant) was provided after real-time ultrasound was performed. Once real-time was done a 3D volume of the adnexal mass was acquired and stored by this examiner. Two examiners, unaware of the real-time ultrasound results, evaluated the 3D volumes using multiplanar display and virtual navigation and also had to provide a presumptive diagnosis (benign or malignant). These two examiners, like the first one, had information about patient's age, menopausal status and complaints. All women underwent surgery or were followed-up until cyst resolution. Histologic diagnosis was used as gold standard. Cysts that resolved spontaneously were considered as benign for analytical purposes. The Kappa index was used to assess the agreement between real time ultrasound and 3D volume analysis. Sensitivity and specificity of both methods were calculated and compared using McNemar test. RESULTS: Forty-one masses were malignant and 58 were benign. Agreement between real-time ultrasound and 3D volume analysis was good for both off-line examiners (Kappa index: 0.82, 95% CI: 0.70-0.93 and 0.78, 95% CI: 0.65-0.90). Sensitivities for real-time ultrasound and 3D volume analyses were 100%, 93% and 90%, respectively (p>0.05). Specificities for real-time ultrasound and 3D volume analyses were 91%, 84% and 86%, respectively (p>0.05). CONCLUSIONS: Off-line 3D volume analysis may be a useful method for assessing adnexal masses, showing a good agreement with real-time ultrasound and having a similar diagnostic performance.