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.

Diagnostic value of a urine test in pregnancy of unknown location.

BACKGRO: Pregnancy of unknown location (PUL) is a term used when there is a positive pregnancy test but no sonographic evidence for an intrauterine pregnancy (IUP) or ectopic pregnancy (EP). This term is a classification and not a final diagnosis. OBJECTIVE: This study aimed to evaluate the diagnostic value of the Inexscreen test on the outcome of patients with pregnancies of unknown location. STUDY DESIGN: In this prospective study, a total of 251 patients with a diagnosis of pregnancy of unknown location at the gynecologic emergency department of the La Conception Hospital, Marseille, France, between June 2015 and February 2019 were included. The Inexscreen (semiquantitative determination of intact human urinary chorionic gonadotropin) test was performed on patients with a diagnosis of pregnancy of unknown location. They participated in the study after information and consent collection. The main outcome measures (sensitivity, specificity, predictive values, and the Youden index) of Inexscreen were calculated for the diagnosis of abnormal pregnancy (nonprogressive pregnancy) and ectopic pregnancy. RESULTS: The sensitivity and specificity of Inexscreen for the diagnosis of abnormal pregnancy in patients with pregnancy of unknown location were 56.3% (95% confidence interval, 47.0%-65.1%) and 62.8% (95% confidence interval, 53.1%-71.5%), respectively. The sensitivity and specificity of Inexscreen for the diagnosis of ectopic pregnancy in patients with pregnancy of unknown location were 81.3% (95% confidence interval, 57.0%-93.4%) and 55.6% (95% confidence interval, 48.6%-62.3%), respectively. The positive predictive value and negative predictive value of Inexscreen for ectopic pregnancy were 12.9% (95% confidence interval, 7.7%-20.8%) and 97.4% (95% confidence interval, 92.5%-99.1%), respectively. CONCLUSION: Inexscreen is a rapid, non-operator-dependent, noninvasive, and inexpensive test that allows the selection of patients at high risk of ectopic pregnancy in case of pregnancy of unknown location. This test allows an adapted follow-up according to the technical platform available in a gynecologic emergency service.

Robot-assisted tubo-tubal reanastomosis after sterilization in 10 steps.

Five to 20% of women regret having a tubal ligation. These women are generally otherwise fertile and have a better chance of pregnancy than other patients experiencing infertility, whether by in vitro fertilization or after tubal surgery. Historically, tubal anastomosis surgery has long been performed by microsurgery through laparotomy, which provided very high precision but was associated with some degree of morbidity. The parallel development of in vitro fertilization and laparoscopy have contributed to reducing the indications for tubal surgery. The laparoscopic approach is challenging because of the number and precision of the sutures needed. The robot-assisted laparoscopic approach may reduce the surgical difficulty and improve the accessibility of this technique. We have described the technique of tubo-tubal reanastomosis after sterilization with robot-assisted laparoscopy in 10 steps. Robot-assisted laparoscopy provides favourable conditions for performing tubo-tubal reanastomosis after sterilization due to the camera stability, precision of movement, and amplitude of articulations.

Outpatient laparoscopic sacrocolpopexy: Feasibility and patient satisfaction.

STUDY OBJECTIVE: To assess the feasibility and patient satisfaction of outpatient management of laparoscopic sacrocolpopexy. DESIGN: Observational study. SETTING: Multicentric study in four French centers: La Conception University Hospital, Marseille; Simone Veil Hospital, Cannes; Simone Veil Hospital, Eaubonne; and Jules Verne Clinic, Nantes. PATIENTS: A total of 125 patients required laparoscopic sacrocolpopexy and accepted outpatient surgery. INTERVENTIONS: Assessment of outpatient surgery success, patient satisfaction, and self-evaluated symptom improvement after surgery. MEASUREMENTS AND MAIN RESULTS: During the study period, 574 patients required laparoscopic sacrocolpopexy, and 21.8% (125) of them met the inclusion criteria for outpatient surgery. The success rate for outpatient surgery was 95.2% (119/125). The perioperative complication rate was 4% (5/125). Among the successfully discharged outpatients, 2.5% (3/119) of them had an unscheduled visit within seven days. Among the discharged patients, 84% (105/125) answered the satisfaction questionnaire, and 88.5% (93/105) declared themselves as "satisfied" or "very satisfied" with the procedures. Patients who declared their conditions to have been "very improved" or "improved" compared to their preoperative symptomatology were 76.9% (83/108) of cases. CONCLUSION: A high success rate for outpatient laparoscopic sacrocolpopexy associated with a high satisfaction rate were found in our study. The development of outpatient options for laparoscopic sacrocolpopexy was supported by our data.

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.

Midline rectovaginal fascial plication: Anatomical and functional outcomes at one year.

OBJECTIVES: To evaluate anatomical and functional results at one year of midline rectovaginal fascial plication (MFP) for rectocele. MATERIAL AND METHODS: Single-center observational study performed in a gynecologic-obstetrics department of a university hospital. Inclusion criteria were patients with isolated or associated rectocele treated by MFP. The success rate defined by a Bp point < 0 cm, improvement of symptoms, and satisfaction were evaluated at one year. Quality of life questionnaires were distributed pre- and postoperatively at one year. RESULTS: 34/46 (74%) patients were interviewed pre and postoperatively including a POPQ evaluation in only 30 patients. Anatomical success rate was 28/30 (93%) (p < 0.0001). There was an improvement in the sensation of vaginal bulge with 22/34 patients (65%) no longer having this symptom (p < 0.0001) and only one patient (1/34, 3%) underwent surgery for recurrence of the rectocele. 24/34 patients (71%) were satisfied with their surgery at one year. CONCLUSION: Anatomical and functional results of MFP for rectocele are encouraging and must be confirmed on a longer follow up.

A Framework Proposal for Quality and Safety Measurement in Gynecologic Emergency Care.

OBJECTIVE: To define and assess the prevalence of potentially life-threatening gynecologic emergencies among women presenting for acute pelvic pain for the purpose of developing measures to audit quality of care in emergency departments. METHODS: We conducted a mixed-methods multicenter study at gynecologic emergency departments in France and Belgium. A modified Delphi procedure was first conducted in 2014 among health care professionals to define relevant combinations of potentially life-threatening conditions and near misses in the field of gynecologic emergency care. A prospective case-cohort study in the spring of 2015 then assessed the prevalence of these potentially life-threatening emergencies and near misses among women of reproductive age presenting for acute pelvic pain. Women in the case group were identified at 21 participating centers. The control group consisted of a sample of women hospitalized for acute pelvic pain not caused by a potentially life-threatening condition and a 10% random sample of outpatients. RESULTS: Eight gynecologic emergencies and 17 criteria for near misses were identified using the Delphi procedure. Among the 3,825 women who presented for acute pelvic pain, 130 (3%) were considered to have a potentially life-threatening condition. The most common diagnoses were ectopic pregnancies with severe bleeding (n=54; 42%), complex pelvic inflammatory disease (n=30; 23%), adnexal torsion (n=20; 15%), hemorrhagic miscarriage (n=15; 12%), and severe appendicitis (n=6; 5%). The control group comprised 225 hospitalized women and 381 outpatients. Diagnostic errors occurred more frequently among women with potentially life-threatening emergencies than among either hospitalized (odds ratio [OR] 1.7, 95% CI 1.1-2.7) or outpatient (OR 14.7, 95% CI 8.1-26.8) women in the control group. Of the women with potentially life-threatening conditions, 26 met near-miss criteria compared with six with not potentially life-threatening conditions (OR 25.6, 95% CI 10.9-70.7). CONCLUSIONS: Potentially life-threatening gynecologic emergencies are high-risk conditions that may serve as a useful framework to improve quality and safety in emergency care.

Risk of de novo posterior vaginal prolapse after anterior laparoscopic sacrocolpopexy: Evaluation at one year.

INTRODUCTION AND HYPOTHESIS: Treatment of anterior vaginal and/or apical prolapse by sacrocolpopexy is most often performed by systematic placement of two non-resorbable meshes, anterior and posterior, whether or not there is an associated posterior vaginal prolapse. We believe that isolated correction of an anterior vaginal and/or apical prolapse in the absence of posterior vaginal prolapse is not associated with a higher rate of de novo posterior vaginal prolapse. METHOD: A prospective, observational, monocenter study performed in the Gynecology unit of the Conception UHC in Marseille from May 2011 to October 2014. Patients over 18 years of age exhibiting an anterior vaginal and/or apical prolapse of stage ≥ 2 of the POP-Q classification resulting in functional impairment with alteration of the quality of life, without an associated posterior vaginal prolapse were included and underwent a laparoscopic anterior sacrocolpopexy (ASP). They were seen again in consultation one year from the intervention. Validated quality of life questionnaires were completed pre- and one year postoperatively. RESULTS: 50 patients were included. The rate of de novo posterior vaginal prolapse was 8/50 (16 %). At one year, there was a significant improvement in terms of the SPDI-20 and SPIQ-7 (p < 0.0001) questionnaire, without significant improvement in the quality of sexual function (PISQ-12 questionnaire) (p = 0.073). CONCLUSION: The risk of de novo posterior vaginal prolapse at one year is low when an ASP is carried out.

Evaluation of a follow-up customized strategy for women treated with methotrexate for an ectopic pregnancy: An observational study.

OBJECTIVE: To evaluate a follow-up customized strategy used in women treated with methotrexate for tubal ectopic pregnancy. STUDY DESIGN: This observational monocentric study took place from November 2009 to December 2015 in the emergency unit at La Conception University Hospital in Marseille, France. 440 women were treated by methotrexate for tubal ectopic pregnancy. Women were assigned in a classic follow up protocol with a weekly hCG evaluation (conventional protocol) if the drop in hCG between D1 and D4 was inferior to 20% or in an alternative follow up (streamlined protocol) with a hCG evaluation at one month. The main outcome measures were the success rate, the proportion of women requiring several methotrexate injections, and the mean number of consultations per women and duration of the follow-up. RESULTS: During this period, the success rate was 348/440 (79.1%). The rate of women requiring 1, 2, or 3 injections and of women lost to follow-up were comparable between the two protocols. The mean number of consultations per woman was 3.6 ± 1.33 vs. 5.95 ± 2.25 days (p < 0.0001), and the follow-up was 27.5 ± 12 vs. 28.1 ± 15.4 (p = 0.6) respectively in the conventional protocol group and the streamlined. CONCLUSION: Our customized strategy allows for a decrease in the number of consultations per woman without changing the success rate or the need for methotrexate injection. hCG count drop between D1 and D4 allows for the selection of a low-risk group that can benefit from appropriate aftercare.

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.

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.

Overview and guidelines of off-label use of methotrexate in ectopic pregnancy: report by CNGOF.

Our objective is to describe off-label use of methotrexate in ectopic pregnancy treatment using evidence based medicine. The patient group includes all women with a pregnancy outside the usual endometrium, or of unknown location. Method used was a Medline search on ectopic pregnancy managed using methotrexate treatment; evidence synthesis was done based on this current literature analysis. Level of evidence (LE) were given according to the centre for evidence base medicine rules. Grade was proposed for guidelines but no recommendation was possible as misoprostol is off label use for all the indications studied. In the absence of any contraindication, the protocol recommended for medical treatment of ectopic pregnancy is a single intramuscular injection of methotrexate (MTX) at a dosage of 1mg/kg or 50mg/m(2) (Grade A). It can be repeated once at the same dose should the hCG concentration not fall sufficiently. Pretreatment laboratory results must include a complete blood count and kidney and liver function tests (in accordance with its marketing authorization). MTX is an alternative to conservative treatment such as laparoscopic salpingotomy for uncomplicated tubal pregnancy (Grade A) with pretreatment hCG levels≤5000IU/l (Grade B). Expectant management is preferred for hCG levels<1000IU/l or in the process of spontaneous decreasing (Grade B). Intramuscular MTX is also recommended after the failure of surgical salpingotomy (Grade C) or immediately after surgery, if monitoring is not possible. Except in special circumstances, a local insitu ultrasound-guided MTX injection is not recommended for unruptured tubal pregnancies (Grade B). In situ MTX is an option for treating cervical, interstitial, or cesarean-scar pregnancies (Grade C). In pregnancies of unknown location persisting more than 10days in an asymptomatic woman who has an hCG level>2000IU/l, routine MTX treatment is an option. MTX is not indicated for combination with treatments such as mifepristone or potassium.