vNOTEsHC : Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopic for large uteri: study protocol for a multicentre randomised controlled trial.

Background: In France, 62,000 hysterectomies are performed per year, 70% of which are benign. The choice of approach (laparotomy, laparoscopy or vaginal route) is particularly important in the case of large uterus (> 280g) which are associated with a higher risk of complications. The current data are not sufficient to favour one or other approach. A new medical device, the vNOTES (Natural Vaginal Orifice Transluminal Endoscopy System), offers the advantage of both laparoscopic and vaginal route for pelvic surgery. Objectives: To demonstrate the superiority in terms of intraoperative and postoperative complications of the use of a natural orifice transluminal endoscopic hysterectomy system (vNOTES) versus laparoscopic hysterectomy for benign pathologies on estimated large volume uteri (>280g). Materials and Methods: A randomised, double-blind, superiority trial will be performed at five hospital centres. Women with benign uterine pathology requiring hysterectomy and with a large uterus (> 280g) will be randomised to receive either laparoscopic or vNOTES hysterectomy. Main outcome measures: The primary outcome will be the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Secondary outcomes will be conversion during surgery, duration of surgery and hospitalisation, postoperative pain, postoperative complications, resumption of sexual life and satisfaction with the surgical team. Results: 248 women will be randomised. Conclusion: This trial will provide a better understanding of the approach to large uteri optimise the care of these thousands of women undergoing hysterectomy. What's new?: This trial will evaluate the vNotes for large uteri.

The psychological impact of therapeutic changes during the COVID-19-lockdown for gynaecological and breast cancer patients.

OBJECTIVE: The exceptional health situation related to the Coronavirus 2019 (COVID-19) pandemic has required an in-depth and immediate reorganisation of gynaecological cancer care. The main objective was to assess the psychological impact of such treatment modifications during the lockdown period for gynaecological and breast cancer patients. PATIENTS AND METHODS: A multicentre prospective study was conducted in three university gynaecological cancer wards (Hospices Civils de Lyon, France) during the French first lockdown (16th March to 11th May 2020). All patients with non-metastatic breast cancer or gynaecological cancer were included. Data was collected regarding treatment modifications (delay, cancellation, change of therapeutic plan). The psychological impact of treatment modifications during and after the lockdown was assessed by validated questionnaires (SF-12, EORTC-QLQ-C30, HADS). RESULTS: A total of 205 consecutive patients were included, aged 60.5 ± 1.0 years. Seven patients (3.4%) presented a SARS-CoV-2 infection, and two patients died. Treatment was maintained for 122 (59.5%) patients, postponed for 72 (35.1%) and cancelled for 11 (5.4%). During the lockdown, 35/118 (29.7%) patients suffered from confirmed anxiety and the mean fatigue-EORTC score was 48.00 ± 2.51; it was 38.64 ± 2.33 (p = 0.02) after the lockdown. After the lockdown and compared to the lockdown period, the mental SF-12 score and overall health status EORTC score were significantly higher (45.03 ± 1.06 vs 41.71 ± 1.15, p = 0.02 and 64.58 ± 1.66 vs 57.44 ± 2.02, p = 0.0007, respectively). The number of confirmed-anxiety cases was significantly higher amongst patients for whom treatment was delayed or cancelled (40.5% vs 23.7%, p = 0.04). CONCLUSION: This study quantified the treatment modifications of gynaecological cancer patients during the COVID-19 lockdown and revealed a poorer psychological state and quality of life during this period, even for patients whose treatment plan was not actually modified. Anxiety was more significant in patients with a delayed or cancelled treatment.

Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up.

INTRODUCTION AND HYPOTHESIS: We assessed 3-year anatomic and functional results using synthetic glue to fix mesh in laparoscopic sacrocolpopexy. METHODS: Prospective multicenter cohort study in three academic urogynecology departments. Seventy consecutive patients with stage ≥ 3 POP-Q (Pelvic Organ Prolapse Quantification) anterior and/or apical prolapse underwent laparoscopic sacrocolpopexy using synthetic surgical glue to fix anterior and posterior meshes to the vagina. Patients were followed up at 1, 2 and 3 years. Primary outcome was anterior and apical anatomic success (POP-Q stage ≤ 1) at 3 years. Secondary outcomes comprised functional results (international quality of life and sexuality scales), mesh-related morbidity and urinary incontinence at 3 years. RESULTS: Mean age was 56.7 ± 1.2 years. Mean follow-up was 43 months. Anterior compartment anatomic success rate was 87% at 2 years (Ba, -2.4 cm; p < 0.0001) and 86.5% at 3 years (Ba, -2.3 cm; p < 0.0001); apical success was 96.3% at 2 years (C, -6.8 cm; p < 0.0001) and 97.3% at 3 years (C, -6.5 cm; p < 0.0001). All quality-of-life scores improved significantly and lastingly at 3 years: PFDI-20, PFIQ-7 and PISQ-12, respectively, p < 0.0001, p < 0.0001 and p = 0.01. There was one case of vaginal mesh exposure at 3 years (2.8%) and five of mesh shrinkage at 1 year (7.8%), none at 2 years and two at 3 years (5.4%). Urinary incontinence rate was 29.7% at 1 year, 14.8% at 2 years and 11.1% at 3 years. CONCLUSION: Vaginal mesh adhesive in laparoscopic sacrocolpopexy remained effective at 3 years, with excellent tolerance and no specific complications. Anatomic and functional results were good and enduring in terms of both anterior and apical correction.

Effective, simple and fast procedure for laparoscopic port-sites wounds closure.

The closure of port-sites wounds, as the ultimate step of surgical laparoscopic procedures, can be allowed by threads, staples, surgical glue or adhesive sutures. We describe a simple and easy skin suturing technique which saves time and provides significant surgical ergonomics.

Easy way to treat female stress urinary incontinence with bulking agents (with video).

Since the recent controversy about vaginal mesh implants, surgeons should use safe and effective devices and procedures to treat female stress urinary incontinence (SUI). We propose to describe the noninvasive and ambulatory technique of the urethral bulking procedure. Bulking agents are a simple, minimally invasive technique that can be offered in the treatment of female SUI.

Ectopic pregnancy management by V-NOTES technique.

Ectopic pregnancy is a frequent and life-threatening risk of childbearing. Its management represents a mainstay of emergency gynecological surgery, and laparoscopy is the surgical gold standard technique. The technique of transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) for the management of ectopic pregnancy is presented herein. The procedure is illustrated by an instructive video article that standardizes the essential steps to make the technique ergonomic and easy to perform (step-by-step explanations). This surgical technique allows to consider vaginal salpingectomy using a combined cœlio-vaginal approach. After a posterior colpotomy, an Alexis retractor was inserted in the pouch of Douglas followed by the placement of a dedicated platform on which three trocars were fixed. Pneumoperitoneum was then achieved. Once the diagnosis of ruptured tubal ectopic pregnancy was established, a salpingectomy was performed. As a minimally invasive approach, this procedure has high patient acceptance and seems to improve favorable clinical outcomes.

Easy way to perform salpingectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) (with video).

The transvaginal natural orifice transluminal endoscopic surgery (vNOTES) is a new minimally invasive and emerging technique. Feasibility and safety profiles of peritoneal access via transvaginal routes have been demonstrated especially for the adnexal surgery. In order to be reproducible and replicable with a standardized procedure, we propose the step-by-step video description of the vNOTES salpingectomy. The advantages of the vNOTES (low postoperative pain, faster postoperative recovery, scarless surgery) could lead to a promising alternative to conventional laparoscopic salpingectomy/adnexectomy.

[Impact of the COVID-19 Outbreak on the management of patients with gynecological cancers]. / Impact de la pandémie de Covid-19 sur les modifications thérapeutiques des patientes atteintes de cancers gynécologiques.

OBJECTIVE: The exceptional health situation related to the SARS-Cov2 coronavirus pandemic (COVID-19) required a deep and very quickly adaptation of management practices in gynecological cancer. The main objective is to estimate the proportion of patients with treatment modifications. METHOD: This is a multicenter prospective study conducted in 3 university gynecological cancer departments (HCLyon, France) during the period of confinement (March 16 to May 11, 2020). All patients with non-metastatic breast cancer or gynecological cancer were included. The planned treatment, postponement, delay and organizational modifications (RCP, teleconsultations) were studied. RESULTS: Two hundred and five consecutive patients were included, average age 60.5±1.0. 7 patients (3.4%) had SARS-Cov-2 infection, 2 patients died. One hundred and twenty-two patients (59.5%) had a treatment maintained, 72 patients (35.1%) postponed, 11 patients (5.4%) cancelled. Of the 115 (56.1%) planned surgeries, 40 (34.8%) postponed, 7 cancelled (6.1%). 9 patients (7.8%) had a surgical modification. Of the 59 (28.8%) radiotherapy treatments scheduled, 24 (40.7%) postponed and 2 (3.4%) cancelled. Of the 56 (27.3%) chemotherapy treatment planned, 8 (14.3%) postponed and 2 (3.6%) cancelled. One hundred and forty-five patients (70.7%) have been discussed in multidisciplinary meeting. One hundred and fifty-eight patients (77%) had a teleconsultation system. CONCLUSION: Our study assessed the impact of the COVID-19 pandemic on therapeutic management of patients with gynecological cancer during the period of confinement. This will probably improve our management of an eventual epidemic rebound or future health crisis.

Minimally invasive management of Bartholin gland abscesses (with demonstrative video).

Bartholin gland abscesses are common problems in women and their management represents a mainstay of gynecology. Various treatment methods have been described. We present a technique performed under local anesthesia, without hospitalization or postoperative care. As part of a minimally invasive approach, this procedure promotes therapeutic de-escalation, has high patient acceptance, improves clinical outcomes and reduces costs. The procedure is highlighted through an instructive video article which standardizes the essential steps, to make the technique ergonomics and easy to perform (step-by-step explanation).