The Effects of a Laparoscopy by Single-Port Endoscopic Access in Benign Adnexal Surgery: A Randomized Controlled Trial.

STUDY OBJECTIVE: To evaluate whether laparoendoscopic single-site surgery (LESS) offers advantages over conventional laparoscopy (CL) in benign adnexal surgery. DESIGN: Randomized controlled study. SETTING: Gynecology-Obstetrics Unit of the University Hospital of the Conception in Marseille, France. PATIENTS: Patients older than 18 years requiring ovarian cystectomy or salpingo-oophorectomy by laparoscopy for symptomatic ovarian cysts requiring benign or prophylactic surgery. INTERVENTIONS: In the case of ovarian cysts, premenopausal patients typically undergo a unilateral cystectomy, whereas postmenopausal patients undergo a unilateral or bilateral salpingo-oophorectomy upon a patient's request. In cases requiring prophylactic surgery, a bilateral salpingo-oophorectomy was performed. All participants were randomly assigned to either the LESS or the CL group. MEASUREMENTS AND MAIN RESULTS: Patients in both groups reported similar levels of pain at 24 hours: Simple Numerical Scale was 1.3 (standard deviation, 1.5) in the LESS group vs 1.7 (standard deviation, 1.5) in the CL group (p = .12), and there were no significant differences in postoperative pain at 2 hours, 4 hours, 6 hours, and 7 days. Furthermore, there was no difference in analgesic consumption. Regarding intraoperative criteria, the only difference was the longer operating time in the LESS group than the CL group. We also found that patients' satisfaction with their scar at 1 month may be higher with LESS than with CL. CONCLUSION: There was no significant difference between the 2 techniques in postoperative pain, although the LESS technique necessitated a longer operative time than the CL technique, while providing better aesthetic result patients.

Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial.

STUDY OBJECTIVE: To compare the AirSeal insufflation system with the standard insufflation system for postoperative abdominal pain after laparoscopic hysterectomy for benign pathology. DESIGN: Randomized controlled trial. SETTING: Teaching Hospital La Conception, Marseille, France, February 2018 to July 2020. PATIENTS: A total of 80 patients scheduled for a laparoscopic hysterectomy for benign pathology (40 per group). INTERVENTION: Laparoscopic hysterectomy using the AirSeal insufflation system with a pneumoperitoneum between 8 and 10 mm Hg compared with the standard insufflation system with a pneumoperitoneum between 12 and 15 mm Hg. MEASUREMENTS AND MAIN RESULTS: The primary end point was abdominal pain at 6 hours after the end of surgery, assessed by a Simple Numerical Scale from 0 to 10. The secondary end points were intraoperative (operating time and difficulty of the surgery felt by the operator), early postoperative (intensity of abdominal and scapular pain at H0 [end of surgery], H2 [two hours after the end of surgery, H12 [twelve hour after the end of surgery], H24 [twenty four hours after the end of surgery], H48 [fourty eight hours after the end of surgery]), and late postoperative (late postoperative complication, estimated time to return to normal life, and overall patient satisfaction assessed by the SF-12 general health survey). The median values for abdominal pain were not different between the 2 groups at 6 hours (AirSeal group median, 0; interquartile range, 2 vs standard laparoscopy group median, 1; interquartile range, 2; p = .41). The abdominal and scapular pain values were similar in both groups at all postoperative times. There were no differences between the groups regarding secondary end points. CONCLUSION: Use of the AirSeal insufflation system with low-pressure pneumoperitoneum in laparoscopic hysterectomy for a benign indication did not reduce postoperative abdominal and scapular pain.

Video-based self-assessment enhances laparoscopic skills on a virtual reality simulator: a randomized controlled trial.

BACKGROUND: Hysterectomy rates are decreasing in many countries, and virtual reality (VR) simulators bring new training opportunities for residents. As coaching interventions while training on a simulated complex procedure represents a resource challenge, alternative strategies to improve surgical skills must be investigated. We sought to determine whether self-guided learning using a video-based self-assessment (SA) leads to improved surgical skills in laparoscopic hysterectomy (LH) on a VR simulator. METHODS: Twenty-four gynecology residents from two university hospitals were randomized into an SA group (n = 12) and a Control group (n = 12). Each participant's baseline performance on a validated VR basic task was assessed. Both groups then performed three virtually simulated LHs during which the participants received no guidance nor feedback. Following each LH, the SA group participants rated the video of their own performance using a generic and a procedure-specific rating scale, while the Control group participants watched an LH video demonstration. The LH videos of both groups' participants were blindly reviewed and rated by expert surgeons, using modified Objective Structured Assessment of Technical Skills scores (OSATS). Objective metrics recorded by the VR simulator were also compared. RESULTS: There was no difference between the groups' baseline performances on the VR basic task. For the first LH, the OSATS-derived scores did not differ between SA and Control groups (9 [7-13] versus 9 [8-14]; p = 0.728). For the third LH, the OSATS-derived scores were higher for the SA group than for the Control group (17 [15-21] versus 15 [11-17], p = 0.039). Between the two groups, the objective metrics did not differ from the first to the third LH. CONCLUSIONS: The use of a structured video-based SA leads to improved procedural skills in LH on a VR simulator compared to watching benchmark expert performance, in a population of residents with moderate experience in the operating room.

Performance Assessment for Total Laparoscopic Hysterectomy in the Operating Room: Validity Evidence of a Procedure-specific Rating Scale.

STUDY OBJECTIVE: The technical conduct of total laparoscopic hysterectomy (LH) is critical to surgical outcomes. This study explored the validity evidence of an objective scale specific to the assessment of technical skills (H-OSATS) for 7 tasks of an LH with salpingo-oophorectomy procedure performed in the operating room. DESIGN: Observational cohort study. SETTING: Two academic hospitals in Marseille and Montpellier, France. PATIENTS: Three groups of operators (novice, intermediate, and experienced surgeons) were video recorded during their live performances of LH on a simple case. For each group, a dozen unedited videos were obtained for the following tasks: division of the round ligament, division of the infundibulopelvic ligament, creation of the bladder flap, opening of the posterior peritoneum, division of the uterine vessels, colpotomy, and closure of the vault. INTERVENTIONS: Two qualified raters blindly assessed each video using the H-OSATS rating scale. Inter-rater reliability and test-retest reliability were calculated as measures of internal structure. In a separate round of evaluations, the raters provided a global competent/noncompetent decision for each performance. As a measure of consequential validity, a pass/fail score was set for each task using the contrasting group method. MEASUREMENTS AND MAIN RESULTS: Three tasks (creation of the bladder flap, colpotomy, and closure of the vault) displayed sound validity evidence: a meaningful total score difference among the 3 groups of experience as well as between the intermediate and experienced surgeons, reliability outcomes of >0.7, and a pass/fail score with a theoretical false-positive rate of <10%. CONCLUSION: The validity evidence of the H-OSATS rating scale differed for separate evaluations of the 7 tasks. Three tasks (i.e., creation of the bladder flap, colpotomy, and closure of the vault) revealed sound validity evidence, including at the level of the attending surgeon, whereas other tasks were more consistent with low-stakes formative evaluation standards.

Learning Intracorporeal Suture on Pelvitrainer Using a Robotized Versus Conventional Needle Holder.

BACKGROUND: Laparoscopy is the gold standard approach in numerous surgical procedures. A new generation of robotized instruments has been developed to compensate for the ergonomic constraints of conventional instruments. The main objective was to compare the learning curves of novices for intracorporeal suturing on a laparoscopy pelvitrainer, using either a robotized needle holder or conventional needle holders. The post-training performances under ergonomically difficult conditions were also analyzed. MATERIALS AND METHODS: Fifth-year medical students were randomized in group A using a robotized needle holder (JAIMY; Endocontrol, Grenoble, France) and group B using straight conventional needle holders. They undertook four training sessions (intracorporeal knot-tying task) followed by an evaluation session (intracorporeal knots-tying task, frontal suture, and hexagonal suture). RESULTS: Twenty participants were included. The performances of the two groups (n = 10) were not significantly different at baseline. During the training sessions, there was a learning curve with a plateau at the third session for both the groups. At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762). There was a significant difference between group A and group B for the frontal suture (median global score: 15.75 versus 3.75 respectively; P = 0.005) but not for the hexagonal suture (median global score: 18 versus 15 respectively; P = 0.284). CONCLUSIONS: Learning curves were equally fast using the robotized needle holder versus conventional instruments and led to equivalent performances. Under ergonomically difficult conditions, the robotized needle holder provided an advantage relative to conventional instruments.

Laparoscopic Essure® Device Removal by En Bloc Salpingectomy-Cornuectomy with Intraoperative X-Ray Checking: A Retrospective Cohort Study.

STUDY OBJECTIVE: To evaluate the feasibility, efficacy, and morbidity of Essure® device removal via laparoscopic en bloc salpingectomy-cornuectomy resection (LSC) and the utility of confirmation of complete removal with an intraoperative X-ray of the removed specimen (IX-S). DESIGN: Retrospective observational cohort study. SETTING: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. PATIENTS: Women who were not seeking future fertility seeking Essure® device removal by salpingectomy, between February 2017 and August 2018. INTERVENTIONS: All women underwent LSC. An IX-S was performed to confirm complete Essure® device removal. In the case of an unsatisfactory IX-S, an intraoperative pelvic X-ray control of the patient (IX-P) was performed. If IX-P diagnosed residual Essure® fragments, an additional resection was performed, and the removed tissue was checked by IX-S. MEASUREMENTS AND MAIN RESULTS: We included 72 women, and a total of 140 Essure® devices were removed. The IX-S confirmed complete Essure® device removal in 131 of 140 cases (93.6%) in 63 of 72 women (87.5%). Out of the 9 women with unsatisfactory IX-S, 6 had no residual Essure® fragments at IX-P, and Essure® device removal was considered complete. Three women had a persistent Essure® fragment at IX-P: an additional resection allowed complete removal in 2 cases and resulted in failure in 1 of 140 case (0.7%). There were 2 of 72 women (2.8%) intraoperative complications and 4 of 72 women (5.6%) postoperative grade 1 complications according to the Clavien-Dindo classification. CONCLUSION: Essure® device removal by LSC appears to be an effective and safe procedure. IX-S is a useful method to evaluate whether the removal of Essure® device is complete during an LSC procedure.

Surgery of nonpalpable breast cancer: First step to a virtual per-operative localization? First step to virtual breast cancer localization.

INTRODUCTION: Preoperative localization procedures of occult breast cancer (radioisotopic and wire localization) are invasive and uncomfortable. We have evaluated a novel technique which allows a virtual localization. MATERIAL AND METHODS: Our retrospective study focused on patients treated for occult and unifocal breast cancer from September 2016 to June 2017. All patients had radioisotopic preoperative localization. We included patients who had a preoperative prone Magnetic Resonance Imaging (MRI) and an intraoperative 3D optical scan. During surgery, the surgeon localized the tumor thanks to a gamma detection probe and marked the localization on the skin with a black marker. The breast was then optically scanned. MRI was adjusted to the optical surface to match the exact breast position in the Operating Room. The virtual localization provided by the 3D breast modeling tool was retrospectively compared with the radioisotopic localization, defined as the pen mark visible in the optical scan. RESULTS: Nine patients were included in this feasibility study. Tumors were successfully localized in the respective breast quadrant. The mean cutaneous distance between virtual and radioisotopic localization was 1.4 cm in patients with low breast volume (5/9) and 2.8 cm in those with large breast volume (4/9). CONCLUSION: We developed a research prototype which enables virtual preoperative localization of nonpalpable breast lesions using MRI images and intraoperative optical scanning. Parameter optimization is required and will lead to a precise and noninvasive tool. By adding augmented reality, it will be possible to initiate a prospective study to compare this tool with the traditional localizations.

Vaginal Hysterectomy with Salpingectomy for Essure Insert Removal.

STUDY OBJECTIVE: To evaluate the feasibility of an en-bloc salpingectomy at the time of vaginal hysterectomy for removal of Essure inserts. DESIGN: Prospective observational study (Canadian Task Force classification II-1). SETTING: Monocenter study at the Conception University Hospital Center, Marseille, France. PATIENTS: Women seeking removal of the Essure device and candidate for vaginal hysterectomy from January 1, 2017 to January 31, 2018. INTERVENTIONS: Patient underwent a total hysterectomy and bilateral salpingectomy by the vaginal route (VH-S) with en-bloc removal of each hemiuterus with the ipsilateral fallopian tube, thereby allowing for removal of the Essure inserts without fragmentation. MEASUREMENTS AND MAIN RESULTS: Twenty-six VH-S were performed. There was no converted case to laparoscopy or laparotomy because of issues regarding feasibility or complications. Removal of each hemiuterus with the ipsilateral tube as a single unit was feasible in all cases. There was 1 Clavien-Dindo grade 1 perioperative complication: a bladder injury that required 10days of urinary catheterization. There were 2 grade 2 postoperative complications: 1 case of metrorrhagia of a granuloma on the vaginal fundus that was treated with silver nitrate and 1 case of acute urinary retention that required urinary catheterization for 24hours. CONCLUSION: Performing a VH-S with en-bloc removal of the hemiuterus with the ipsilateral tube without fragmentation orsectioning of the Essure inserts appears to be feasible. The vaginal route can hence be an approach for women who undergo hysterectomy during Essure insert surgery removal.

Development of an evidence-based training program for laparoscopic hysterectomy on a virtual reality simulator.

BACKGROUND: Substantial evidence in the scientific literature supports the use of simulation for surgical education. However, curricula lack for complex laparoscopic procedures in gynecology. The objective was to evaluate the validity of a program that reproduces key specific components of a laparoscopic hysterectomy (LH) procedure until colpotomy on a virtual reality (VR) simulator and to develop an evidence-based and stepwise training curriculum. METHODS: This prospective cohort study was conducted in a Marseille teaching hospital. Forty participants were enrolled and were divided into experienced (senior surgeons who had performed more than 100 LH; n = 8), intermediate (surgical trainees who had performed 2-10 LH; n = 8) and inexperienced (n = 24) groups. Baselines were assessed on a validated basic task. Participants were tested for the LH procedure on a high-fidelity VR simulator. Validity evidence was proposed as the ability to differentiate between the three levels of experience. Inexperienced subjects performed ten repetitions for learning curve analysis. Proficiency measures were based on experienced surgeons' performances. Outcome measures were simulator-derived metrics and Objective Structured Assessment of Technical Skills (OSATS) scores. RESULTS: Quantitative analysis found significant inter-group differences between experienced intermediate and inexperienced groups for time (1369, 2385 and 3370 s; p < 0.001), number of movements (2033, 3195 and 4056; p = 0.001), path length (3390, 4526 and 5749 cm; p = 0.002), idle time (357, 654 and 747 s; p = 0.001), respect for tissue (24, 40 and 84; p = 0.01) and number of bladder injuries (0.13, 0 and 4.27; p < 0.001). Learning curves plateaued at the 2nd to 6th repetition. Further qualitative analysis found significant inter-group OSATS score differences at first repetition (22, 15 and 8, respectively; p < 0.001) and second repetition (25.5, 19.5 and 14; p < 0.001). CONCLUSIONS: The VR program for LH accrued validity evidence and allowed the development of a training curriculum using a structured scientific methodology.

Robotic-Assisted Laparoscopic Treatment of Residual Ectopic Pregnancy in a Previous Cesarean Section Scar: A Case Report.

STUDY OBJECTIVE: To describe a technique of robotic-assisted laparoscopy of residual cesarean scar pregnancy (CSP) and uterine defect repair. DESIGN: Video case report, with step-by-step explanation of the procedure (Canadian Task Force classification III) SETTING: CSP may be treated by different approaches including surgery and methotrexate. Successful methotrexate treatments avoid an emergency surgical treatment. In these cases a residual CSP often remains and should be removed in women who desire to conceive. CSP is often associated with a cesarean section scar defect called an isthmocele. In case of isthmocele with important defect and desire for pregnancy, laparoscopic repair may be proposed. Diagnosis and treatment of isthmocele is usually performed in a second time after a successful treatment of CSP. In this case, a surgical treatment including the removal of the residual CSP and treatment of the isthmocele may be proposed. INTERVENTION: In this video we describe a technique for the surgical removal of residual CSP and isthmocele treatment by robotic-assisted laparoscopy. A 32-year-old patient developed a CSP treated by 2 in situ injections of methotrexate. A magnetic resonance imaging study performed 1 month after the last methotrexate injection revealed a persistent 4-cm residual CSP, associated with an isthmocele. Preoperative uterine artery embolization was performed to reduce intraoperative bleeding. After localization of the residual CSP on the left side, a temporary left uterine occlusion was performed. Residual CSP was totally removed. The residual defect and isthmocele were closed using delayed absorbable suture. CONCLUSION: Robotic-assisted laparoscopic removal of residual CSP and isthmocele treatment is a feasible and safe procedure. This procedure may be proposed in patients presenting with this condition after a methotrexate treatment of CSP.

Single-Port Laparoscopy vs Conventional Laparoscopy in Benign Adnexal Diseases: A Systematic Review and Meta-Analysis.

Single-port laparoscopy (SPL) was developed approximately 30 years ago in minimally invasive surgery. Literature comparing SPL with conventional laparoscopy (CL) for adnexal surgery (i.e., cystectomy and adnexectomy) is inconsistent. The objective of this systematic review and meta-analysis was to evaluate the advantage of SPL over CL for adnexal surgery. PubMed, Embase, and MEDLINE were searched for publications in English and in French published between 1975 and November 2015 using the following key words: (((single port) or (single site) or (one port) or (single-port access laparoscopy) or (single-site laparoscopy) or (laparoscopic single-site surgery)) and ((adnexal disease) or (ovarian cystectomy) or (ovariectomy) or (adnexectomy))) not (pregnancy). The primary outcome was postoperative pain assessed at 24 hours postsurgery. The secondary outcomes were postoperative pain at 6 and 48 hours postsurgery, analgesic consumption, operative time, blood loss, laparotomy conversion rate, mean hospital stay, and cosmetic results at 1 month. Sixteen relevant articles were identified by electronic search. The pooled analysis of randomized trials showed no significant difference between SPL and CL in terms of postoperative pain at 6 and 24 hours, blood loss, mean length of hospital stay, cosmetic results, and laparotomy conversion rate; however, operative time was longer for SPL (p = .03). The pooled analysis including all the selected studies showed no significant difference for all of these outcomes. This review and meta-analysis found no significant difference between SPL and CL for adnexal surgery, except for operative time. Further large-scale randomized trials should be conducted to investigate the potential advantages of SPL over CL before this laparoscopic approach can be recommended.

Laparoscopic ovariectomy by single-port access for ovarian cryopreservation.

PURPOSE: The aim of this study is to assess the feasibility of ovariectomy by single-port access laparoscopy for cryopreservation. METHODS: Observational prospective monocentric study including patients referred for an ovariectomy for ovarian tissue cryopreservation underwent ovariectomy by single-port access laparoscopy. Feasibility, intra- and post-operative complications, and quality of the ovarian tissue collected were reported. RESULTS: Height patients were included. No conversion to standard laparoscopy or laparotomy was performed and no intra- or post-operative complications were reported. Median duration of surgery was 35 min (30-60). The quality of all the ovarian tissue collected was correct, and cryopreservation was possible for all patients. CONCLUSIONS: Ovariectomy for cryopreservation by laparoscopy with SPA seems feasible. The advantages of this technique are particularly interesting in these patients who require the least aggressive surgical technique possible and a rapid convalescence.

Supracervical hysterectomy by laparoendoscopic single site surgery.

OBJECTIVE: To evaluate the feasibility of laparoscopic supracervical hysterectomy (LSH) by single port access (SPA) with transcervical morcellation. STUDY DESIGN: Observational study conducted between September 2010 and March 2012 in two departments of Gynaecology. Forty women who required hysterectomy underwent LSH by SPA with transcervical morcellation. RESULTS: LSH by SPA with transcervical morcellation was completed successfully in 37/40 (93.5 %) patients. Mean operating time was 128 (±55) min and mean hospital stay was 3.5 (±1) days. The mean of uterus weight was 310 (±214) g. The mean estimated blood loss was 250 (±110) ml. Four women (10 %) required a second surgical intervention including two cases of endocervical bleeding. CONCLUSION: LSH by SPA with transcervical morcellation is a feasible procedure.

vNOTES hysterectomy using the lateral window technique in case of a ventrofixed uterus following previous cesarean sections: A video article.

vNOTES uses the vagina as the surgical channel for endoscopy and achieves improved cosmesis compared to conventional laparoscopy as there are no abdominal incisions. Ventrofixation of the uterus to the abdominal wall following previous cesarean sections further adds to the surgeon's concern of bladder injury. In such cases, a modification of the technique is proposed: introducing the vNOTES port first, before the opening of the vesico-uterine peritoneal folds, thus carried out under endoscopic view. Medial anterior vesico-uterine adhesions are identified and circumscribed by creating a lateral window in the broad ligament on both sides. This allows the cutting of adhesions under endoscopic view to minimize the risk of bladder injuries. The aim of this technical note is to present this modification of the surgical technique for vNOTES hysterectomy in case of ventrofixed uterus.

Clues to revising the conventional diagnostic algorithm for endometriosis.

Endometriosis is a complex gynecologic disorder characterized primarily by symptoms of pelvic pain, infertility, and altered quality of life. National and international guidelines highlight the diagnostic difficulties and lack of conclusive diagnostic tools for endometriosis. Furthermore, guidelines are becoming questionable at an increasingly rapid rate as new diagnostic techniques emerge. This work aims to provide a knowledge synthesis of the relevance of various diagnostic tools and to assess areas of improvement of conventional algorithms. MEDLINE and Cochrane Library databases were searched from January 2021 to December 2023 using relevant key words. Articles evaluating the diagnostic relevance and performance of various tools were included and independently reviewed by the authors for eligibility. Included studies were assessed using the GRADE and QUADAS-2 tools. Of the 4204 retrieved articles, 26 were included. While anamnesis and clinical examination do contribute to diagnostic accuracy, their level of evidence and impact on the diagnostic process remains limited. Although imaging techniques are recommended to investigate endometriosis, ultrasonography remains highly operator dependent. Magnetic resonance imaging appears to exhibit higher sensitivities than ultrasound. However, concerns persist with regards to the terminology, anatomical definition of lesions, and accuracies of both ultrasound and magnetic resonance imaging. Recently, several biological markers have been studied and cumulative evidence supports the contribution of noncoding RNAs to the diagnosis of endometriosis. Marginal improvements have been suggested for anamnesis, clinical examination, and imaging examinations. Conversely, some biomarkers, including the saliva microRNA signature for endometriosis, have emerged as diagnostic tools which inspire reflection on the revision of conventional diagnostic algorithms.

Long-term quality of life after surgical Essure removal for device-attributed symptoms.

OBJECTIVE: To analyze quality of life(QoL) and symptom resolution after surgical removal of Essure devices. METHODS: Single-center cohort study which included patients with Essure removal between February 2017 and March 2018. Surgery was performed in 65 patients by laparoscopy (Salpingectomy only or Hysterectomy). Questionnaires were used to assess QoL(SF-36), emotional disorders(HAD) and symptoms preoperatively, at 3 months and 4 years postoperatively. RESULTS: 4(6,1%) and 16(24,6%) patients were lost of follow-up at three months and 4 years postoperatively respectively. Four(6,1%) intraoperative surgical complications occurred. During the three-months postoperative period, 3(4,6%) complications occurred: five Clavien Dindo Grade 1 complications (umbilical hematoma) and one Grade 2 complication (hyperthermia and digestive disorder requiring antibiotic therapy). Preoperative QoL scores were lower than those of general population. Scores were significantly improved at 3 months and 4 years postoperatively. At 4 years postoperatively, 17/49(34,7%) had a complete regression of symptoms, 21/49(42,8%) partial resolution and 11/49(22,4%) no improvement. 27/49(55,1%) patients made the connection between symptoms and ESSURE device after media coverage. 22/49(44,89 %) were influenced by media coverage in their decision of surgery. There was a higher percentage of patients with anxiety disorder before Essure removal than 4 years after [22/44 (50 %) versus 11/44 (25 %); p = 0.0045]. CONCLUSION: Essure removal has a restorative role in terms of QoL in short and long-term. Patients should be informed about possibility of no improvement after surgery and surgical morbidity. Larger prospective cohort is needed to make a well-considered decision about risks of surgery compared with expected benefits.

The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases.

BACKGROUND: Results of IBCSG-23-01-trial which included breast cancer patients with involved sentinel nodes (SN) by isolated-tumor-cells or micro-metastases supported the non-inferiority of completion axillary-lymph-node-dissection (cALND) omission. However, current data are considered insufficient to avoid cALND for all patients with SN-micro-metastases. METHODS: To investigate the impact of cALND omission on disease-free-survival (DFS) and overall survival (OS), we analyzed a cohort of 1421 patients <75 years old with SN-micro-metastases who underwent breast conservative surgery (BCS). We used inverse probability of treatment weighting (IPTW) to obtain adjusted Kaplan-Meier estimators representing the experience in the analysis cohort, based on whether all or none had been subject to cALND omission. RESULTS: Weighted log-rank tests comparing adjusted Kaplan-Meier survival curves showed significant differences in OS (p-value = 0.002) and borderline significant differences in DFS (p-value = 0.090) between cALND omission versus cALND. Cox's regression using stabilized IPTW evidenced an average increase in the risk of death associated with cALND omission (HR = 2.77, CI95% = 1.36-5.66). Subgroup analyses suggest that the rates of recurrence and death associated with cALND omission increase substantially after a large period of time in the half sample of women less likely to miss cALND. CONCLUSIONS: Using IPTW to estimate the causal treatment effect of cALND in a large retrospective cohort, we concluded cALND omission is associated with an increased risk of recurrence and death in women of <75 years old treated by BCS in the absence of a large consensus in favor of omitting cALND. These results are particularly contributive for patients treated by BCS where cALND omission rates increase over time.

Acute Bartholin's gland abscess treatment by simple needle aspiration: A prospective study.

OBJECTIVE: This study aim was to examine the success rate of simple needle aspiration for acute Bartholin's gland abscess and compare it to incision and drainage treatment. STUDY DESIGN: This was a non-randomised prospective study conducted at the academic Hospital of La Conception, Marseille, France. We included 202 women who presented with acute Bartholin's gland abscess between June 2013 and October 2017. The study cohort was subdivided into two treatment groups, simple needle aspiration (134 women) or incision and drainage (42 women), according to the women's preference. Success was considered as the absence of surgical treatment within one year of the initial treatment. RESULTS: The success rate was 68/134 (51% (95% CI: 42-59%)) in the simple needle aspiration group and 25/42 (60%) in the incision drainage group (RR: 0.85, 95% CI: 0.63-1.15, P = 0.3). Among 122/134 (91%) women who completed the satisfaction survey, 99/122 (81%) were satisfied with the simple needle aspiration. CONCLUSIONS: Simple needle aspiration can be offered as first-line treatment for acute Bartholin's gland abscess. Simple needle aspiration can be performed as an outpatient procedure without general anesthesia avoiding surgical treatment in half of the cases one-year post- simple needle aspiration.

Contribution of endocrine therapy in oestrogen receptor-positive pT1a-b breast cancer: Results of a retrospective study.

INTRODUCTION: Few data have been reported regarding endocrine therapy (ET) in patients with small pT1a-b ER-postive breast cancer (BC). Thus, we conducted a study to detect possible survival improvements due to ET in such patients. METHODS: Our retrospective observational study included 5545 patients with pT1a-b ER-positive BC treated in 15 French centres, excluding patients with HER2-positive status, neoadjuvant chemotherapy, ER-negative status, unknown pN status or in situ BC. We estimated disease-free survival (DFS), recurrence-free survival (RFS) and overall survival (OS) via univariate analysis and multivariate Cox regression. RESULTS: Most patients (80.3%: 4453) received ET and-when compared to those without ET-experienced increases of 2.5% and 3.3% in DFS and 1.9% and 4.3% in RFS after 5 and 7 years of follow-up, respectively, with little difference in OS. In Cox regression analysis, no ET was significantly associated with decreased DFS (hazard ratio, HR = 1.275, p = 0.047, 95% CI[1.003-1.620]) but not OS or RFS in all patients, while in 2363 patients with pT1a-b ER-positive grade 2-3 BC, no ET was significantly associated with decreased DFS (HR = 1.502, p = 0.049, 95% CI[1.001-2.252]), but not OS (HR = 1.361, p = 0.272). ET omission was not significantly associated with decreased survival in 3047 patients with pT1a-b ER-positive grade 1 BC. CONCLUSION: Our results indicate that while ET provided a beneficial impact on survival to patients with pT1a-bN0 ER-positive BC-and especially in those with grade 2-3 tumours-no such impact was observed in grade 1 tumours. Consequently, ET should be discussed with these patients, particularly in those with pT1a grade 1 tumours.

Deliberate practice on a virtual reality laparoscopic simulator enhances the quality of surgical technical skills.

INTRODUCTION: Virtual reality (VR) simulation provides unique training opportunities. This study evaluates whether the deliberate practice (DP) can be successfully applied to simulated laparoscopic cholecystectomy (LC) for enhancement of the quality of surgical skills. METHODS: Twenty-six inexperienced surgeons underwent a training program for LC on a VR simulator. Trainees were randomly allocated to 1 of 2 specific protocols of 10 sessions comprising a total of 20 LCs. For each session, the control group performed 2 LCs separated by 30 minutes of occupational activities; the DP group were assigned 30 minutes of DP activities in between 2 LCs. Each participant then performed 2 LCs on a cadaveric porcine model. Quantitative parameters were recorded from the simulator and a motion tracking device; qualitative assessment utilized validated rating scales. RESULTS: Twenty-two subjects completed training. Learning curves on the VR simulator were significant for time taken and number of movements in both groups. The DP group was slower from the third LC (1373 vs. 872 seconds, P = 0.022) and utilized more movements from the seventh (942 vs. 701, P = 0.033). Global rating scores improved significantly in both groups over repeated LCs. The DP group revealed higher scores than control from tenth (19.5 vs. 14, P = 0.014) until the twentieth LC (22 vs. 16, P = 0.003). On the porcine model, the DP group also achieved higher global rating scores (25.5 vs. 19.5, P = 0.002). CONCLUSIONS: VR training improved dexterity for both groups, and led to transfer of skill onto a porcine LC model. The DP group achieved higher quality, and demonstrated superior transfer onto real tissues.