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.

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.

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.

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.

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.

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.

Using pneumovaginoscopy to perform the removal of a vaginal fibroid.

OBJECTIVE: To describe and assess the feasibility of a novel surgical technique (pneumovaginoscopy) for performing vaginal surgery. DESIGN: Video of a single surgical procedure. SETTING: A university hospital. PATIENT(S): A 42-year-old woman, gravida 2 para 2, presented with chronic pelvic pain. Vaginal examination revealed a 4-cm spherical mass bulging through her posterior vaginal wall. Magnetic resonance imaging identified this mass as either a subserosal pedunculated uterine fibroid (type 7 according to the FIGO classification) or an ectopic fibroid of the posterior vaginal wall (type 8). INTERVENTION(S): The whole procedure was performed using pneumovaginoscopy. The GelPOINT V-Path (Applied Medical, Rancho Santa Margarita, California) which is the device most often used to perform transvaginal natural orifice transluminal endoscopic surgical procedures, was introduced into the vagina to create a pneumovagina. Monopolar scissors were used to create an incision through the posterior vaginal wall to reach the fibroid. Myomectomy was performed using traction movements of the fibroid associated with the dissection of the capsule. The absence of a uterine pedicle at the end of the myomectomy was in favor of an ectopic fibroid of the vagina (type 8 of the FIGO classification). The vaginal defect was closed with interrupted sutures using the access points on the GelPOINT. MAIN OUTCOME MEASURE(S): The procedure was easily and efficiently performed using the pneumovaginoscopy technique and lasted less than an hour. The patient was discharged on postoperative day 1 without any postoperative complications. She was symptom-free at her 2-month postoperative visit. RESULT(S): Compared to the classical vaginal approach, pneumovaginoscopy improves visualization through targeted lighting and close-up vision. This technique is particularly interesting in cases where the vaginal opening is narrow and for lesions located in the upper half of the vagina. Because of the unusual expansion of the vagina, increased caution is required to avoid bladder or rectal injuries. CONCLUSION(S): Pneumovaginoscopy is a novel technique that can be performed for vaginal pathologies with the same device used for transvaginal natural orifice transluminal endoscopic surgery. We described this technique and assessed its feasibility.

Vaginal NOTES approach for risk-reducing salpingo-oophorectomy in BRCA mutation carriers: A video demonstration.

Risk-reducing bilateral salpingo-oophorectomy (BSO) is an important option to prevent the development of ovarian and fallopian tube cancers in women with a BRCA1/2 mutation. Conventional laparoscopy is the current preferred technique since it is associated with less morbidity compared to laparotomy. Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a new minimally invasive technique that allows access to the peritoneal cavity through the vagina without skin incisions. The vNOTES technique for risk-reducing BSO is presented herein. This article includes a narrated, step-by-step video demonstration of the entire procedure. Risk-reducing BSO using the vNOTES approach is a feasible technique that appears to be simple, safe, and reproducible. This technique has the potential to improve patients' surgical experience and provide good long-term functional and cosmetics outcomes. This technique needs to be further evaluated and compared to the conventional laparoscopic approach.

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.

Essure removal for device-attributed symptoms: Quality of life evaluation before and after surgical removal.

INTRODUCTION: Increasing reports of adverse effects have raised concerns about the Essure hysteroscopic sterilization method. Women suffering alleged complications of the Essure device often seek surgical removal. This study evaluated the quality of life (QoL) and postoperative outcomes in women undergoing Essure removal. MATERIAL AND METHODS: This observational case series included 95 women. Removal was performed by laparoscopic salpingectomy-cornuectomy, or hysterectomy with bilateral salpingectomy. QoL was assessed preoperatively and three months postoperatively by SF-36 questionnaires [correlated physical health score (PCS) and mental health scores (MCS)]. Symptoms evolution was collected at three months, and complications at one month. RESULTS: Sixty-four laparoscopic salpingectomy-cornuectomies, 33 laparoscopic hysterectomies, and eight vaginal hysterectomies were performed. Four intraoperative complications occurred (one conversion from cornuectomy to laparoscopic hysterectomy, one skin burn, two bladder injuries). Seven postoperative complications occurred (Clavien Dindo, grade 1 or 2). All components of the preoperative QoL scores were lower than those of the general population. PCS scores were lower preoperatively than postoperatively [37.6 versus 50.7; p<0.001]. MCS scores were lower preoperatively than postoperatively [29 versus 52.4; p<0.001]. 71% of patients showed an improvement of at least 10% in both PCS and MCS scores. Systemic and gynecologic symptoms were more frequent before than after surgery (98% versus 50%; p<0.001 and 77% versus 20%; p<0.001 respectively). CONCLUSIONS: Patients seeking Essure removal had an impaired preoperative QoL. They experienced a significant QoL improvement at three months post-operation. These findings will help clinicians to inform patients about their expected postoperative functional status and QoL.

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.

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.

Are Adverse Events Attributed to Essure Associated With Nickel Sensitization?

BACKGROUND: Essure is an effective method for hysteroscopic sterilization. Reports of adverse effects, the underlying mechanisms of which are unknown, have increased in recent years. OBJECTIVE: The aim of the study was to determine whether there is a relationship between adverse events attributed to Essure and nickel sensitization. METHODS: Patients presenting alleged adverse reactions to Essure were referred for nickel patch testing before removal. Data regarding medical history of nickel sensitization and symptoms attributed to Essure were collected. Dimethylglyoxime spot tests were performed on the explanted Essure. There was a follow-up at 3 months to evaluate whether there is improvement of the symptoms after Essure removal. CONCLUSIONS: Nickel sensitization via the classic delayed hypersensitivity pathway did not seem to be responsible for adverse events attributed to Essure. Among systemic symptoms reported, extracutaneous symptoms had the highest prevalence. Systemic contact dermatitis to nickel could not be ruled out in one case.

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 objective assessment tool for total laparoscopic hysterectomy: A Delphi method among experts and evaluation on a virtual reality simulator.

INTRODUCTION: Total Laparoscopic hysterectomy (LH) requires an advanced level of operative skills and training. The aim of this study was to develop an objective scale specific for the assessment of technical skills for LH (H-OSATS) and to demonstrate feasibility of use and validity in a virtual reality setting. MATERIAL AND METHODS: The scale was developed using a hierarchical task analysis and a panel of international experts. A Delphi method obtained consensus among experts on relevant steps that should be included into the H-OSATS scale for assessment of operative performances. Feasibility of use and validity of the scale were evaluated by reviewing video recordings of LH performed on a virtual reality laparoscopic simulator. Three groups of operators of different levels of experience were assessed in a Marseille teaching hospital (10 novices, 8 intermediates and 8 experienced surgeons). Correlations with scores obtained using a recognised generic global rating tool (OSATS) were calculated. RESULTS: A total of 76 discrete steps were identified by the hierarchical task analysis. 14 experts completed the two rounds of the Delphi questionnaire. 64 steps reached consensus and were integrated in the scale. During the validation process, median time to rate each video recording was 25 minutes. There was a significant difference between the novice, intermediate and experienced group for total H-OSATS scores (133, 155.9 and 178.25 respectively; p = 0.002). H-OSATS scale demonstrated high inter-rater reliability (intraclass correlation coefficient [ICC] = 0.930; p<0.001) and test retest reliability (ICC = 0.877; p<0.001). High correlations were found between total H-OSATS scores and OSATS scores (rho = 0.928; p<0.001). CONCLUSION: The H-OSATS scale displayed evidence of validity for assessment of technical performances for LH performed on a virtual reality simulator. The implementation of this scale is expected to facilitate deliberate practice. Next steps should focus on evaluating the validity of the scale in the operating room.

Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic surgery has become the preferred surgical approach due to a reduction in postoperative pain, better recovery, shorter hospitalization, and improved esthetic outcomes. Laparoscopic surgery with single-port laparoscopy (SPL) is a laparoscopic surgery technique that is based on making a single parietal incision using a single trocar specifically designed to allow introduction of several instruments. The level of evidence regarding the advantages of SPL in terms of postoperative pain has remained low despite several randomized studies. Adult patients exhibiting a surgical indication for an a priori benign ovarian pathology or for prophylactic purposes that can be performed by laparoscopy will be randomized to receive conventional laparoscopy (CL) or SPL. The aim of our study is to evaluate whether SPL offers advantages over CL in benign adnexal surgery. METHODS: The patients will be evaluated preoperatively to confirm their eligibility. The perioperative data up to 24 h after the intervention, as well as the postoperative data at day 7 and at one month from the intervention will be collected. The primary outcome for the study will be the postoperative pain at 24 h ± 2 h after the intervention. The pain will be assessed by a numeric rating scale of 0-10. Other outcomes will also be assessed, such as pain at other times, the consumption of analgesics, the operative time, perioperative bleeding, the number of additional trocars in the two groups, the incidence of laparoconversion, the esthetic criteria of the scar at one month, the incidence of complications, and the quality of life at one month. DISCUSSION: If our hypothesis is confirmed, this study will provide evidence that the use of SPL can decrease postoperative pain in adnexal surgery. The standard surgical treatment of this condition would thus be modified. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02739724 . Registered on 12 April 2016.

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.