Risk factors for postoperative pain after cystocele repair with mesh.

INTRODUCTION AND HYPOTHESIS: Prolapse is a common condition seen in women and its therapeutical management consists first and foremost of surgery. Postoperative pain is one of the most common side effects seen after surgery. The objective of this study was to identify risk factors for postoperative pain after cystocele repair with mesh. METHODS: This is a secondary analysis of the multicenter randomized trial PROSPERE, which compared cystocele repair with mesh according to the vaginal or laparoscopic approach. The presence of postoperative pain was assessed by a pain-specific self-reported questionnaire (Questionnaire de Baudelocque). The statistical analysis is based on the Wilcoxon, Chi-squared, and Fisher's tests. RESULTS: The prevalence of postoperative pain (pain persisting more than 6 months) was 39% (80 out of 205, 95% CI 32.4-46.1), with 6.3% (13 out of 205) of chronic pain reports. Preoperative pain was the only statistically significant risk factor OR = 2.32 (p = 0,007; 95% CI 1.24-4.36). CONCLUSIONS: Surgeons must be careful with preoperative painful prolapse and should inform their patient of the risk of developing postoperative chronic pain.

Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry.

OBJECTIVE: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair. DESIGN: Prospective cohort study using a registry. SETTING: Nineteen French surgical centres. POPULATION: A total of 2309 women participated between 2017 and 2019. METHODS: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups. MAIN OUTCOME MEASURES: Serious complications and subsequent reoperations for POP recurrence. RESULTS: The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups. CONCLUSIONS: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making. TWEETABLE ABSTRACT: Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

OBJECTIVE: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. DESIGN: Extended follow up of a randomised trial. SETTING: Eleven centres. POPULATION: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery. METHODS: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). MAIN OUTCOME MEASURES: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications. RESULTS: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)). CONCLUSIONS: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

[Extra uterine leiomyomatosis: Review of the literature]. / La léiomyomatose extra-utérine : revue de la littérature.

Extra-uterine leiomyomatosis is a rare pathology defined by the presence of benign smooth uterine muscle cells in unusual localizations, including different entities. It mainly affects premenopausal women with a medical history of uterine myoma with or without surgical treatment. Three main types are discribed: intraveinous leiomyomatosis, benign metastatisizing leiomyoma and leiomyomatosis peritonealis disseminata. The diagnosis may be complex with many differential diagnosis, and relies on histology. The treatment depends on multiple factors such as age, localization, size, symptoms and associated comorbidities. It is based on surgical resection and hormonal privation, surgical (adnexectomy) or medical (hormonotherapy). There is a high risk of recurrence. Some malignant evolutions have been reported, mostly leiomyosarcoma following peritoneal disseminated leiomyomatosis. Long term follow-up of these patients is mandatory. A particular manifestation of extra-uterine leiomyomatosis is the hereditary leiomyomatosis and renal cell carcinoma (HLRCC) syndrome. It is an autosomal dominant disorder which confers an increased risk of cutaneous and uterine leiomyomas and renal cell cancer, with a poor prognosis due to the urologic tumor.

About a case of traumatic separation of the cervix from the uterine corpus, diagnosed in a context of infertility.

This article reports a case of cervico-isthmic disjunction unnoticed during childhood, diagnosed in a context of primary infertility and endometriosis, and surgically treated. It is an uncommon condition. The diagnosis is most often made as part of an assessment of primary amenorrhea in a young woman with a history of severe pelvic trauma. It is suspected after imaging assessment and confirmed intraoperatively. The treatment consists in an anastomosis between the cervix and the uterine body, after individualizing these two structures, around a drain guiding healing. After this surgery, multiple pregnancies have been successfully carried out.

Outpatient vaginal hysterectomy: Comparison of conventional suture ligature versus electrosurgical bipolar vessel sealing.

OBJECTIVE: The aim of our study was to evaluate the feasibility of vaginal hysterectomy in an ambulatory care system and the best way to perform it between conventional and bipolar vessel sealing system ligatures. PATIENTS AND METHODS: This was a prospective study of 32 patients with vaginal hysterectomy at Lille University Hospital between December 2013 and May 2015. Two surgical techniques were compared: conventional suture ligature (CSL) and electrosurgical bipolar vessel sealing (BVS). Patients stayed in classical hospitalization but were managed how if they were in an ambulatory unit to evaluate their capacity to come back home the same evening of the surgery. The evaluation of same-day discharge was based on Post Anesthetic Discharge Scoring System (PADSS) score?9/10 and Visual Analogic Scale (VAS) score?4/10. Other data collected were: operative time, uterus weight, peroperative bleeding, PADSS score at the 8th postoperative hour, VAS score at the 4th, 6th, 8th, 12th and 24th postoperative hours, the presence of postoperative nausea/vomiting and rehospitalization. RESULTS: In the BVS group, 93.8% of patients validated the combined score (PADSS+VAS) on the evening of the intervention against 50% of patients in the CSL group (P<0.05). Hundred percent of BVS group patients were discharged on the day after surgery against 87.5% in the CSL group. The VAS was significantly lower in the BVS group at the 8th (1.4), 12th (1.2) and 24th (1.3) postoperative hours. Operative time was significantly shorter in the BVS group. We found more events such as nausea/vomiting in the CSL group. CONCLUSION: Vaginal hysterectomy is feasible in an ambulatory care system most of times. By reducing postoperative pain, electrosurgical bipolar vessel sealing would promote outpatient hospitalization.

Simulation training to teach postpartum hemorrhage surgery to residents.

OBJECTIVE: Description of the aims, the framework and the results of a postpartum hemorrhage surgery workshop for residents. STUDY DESIGN: This article is the first publication to describe a simulation workshop for the surgical management of maternal hemorrhage. Training was divided into both theoretical and practical workshops. Four obstetrician-gynecologists supervised residents who performed all the surgical procedures on a cadaver. This training course included the oldest residents at the Faculty of Medicine of Lille and was evaluated by participants using pre-test and post-test questionnaires. Medical knowledge was also evaluated. RESULTS: The pre-test questionnaire showed that medical knowledge for the treatment of postpartum hemorrhage was acceptable but that real practice was lacking. Eighty-six percent of the residents responded that they were not able deal with the situation correctly and most considered it stressful. The post-test questionnaire showed that training greatly improved the participants' theoretical knowledge and technical skills as well as significantly improving self-confidence. CONCLUSIONS: Based on these positive results this workshop will be included in the resident training program and also be extended to professionals as a part of the continuing medical education program.

[Study of the factors motivating refusal of women to participate to a randomized clinical trial in gynecological surgery. Retrospective observational bicentric study]. / Étude des facteurs motivant le refus des femmes de participer à un essai clinique randomisé en chirurgie gynécologique. Étude observationnelle rétrospective bicentrique.

INTRODUCTION: Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. OBJECTIVE: To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. PATIENT AND METHOD: Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. RESULTS: In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close follow-up" in 60% (12/20). CONCLUSION: Our study identified the most influential factors relevant to women decision-making whether or not to participate in RCT in surgery. A number of factors leading to refusal of participation are potentially correctable leading to better recruitment rates in future RCTs. Optimization of information on the principle of randomization, limiting the number of additional visits could help researchers improve participation rates.

[Tubo-ovarian abscesses treatment: Faisability and results of trans-vaginal ultrasound-guided aspiration]. / Évaluation de la faisabilité du traitement des abcès tubo-ovariens par ponction trans-vaginale écho-guidée.

OBJECTIVE: Two years after the French guidelines, the objective was to assess the feasibility and efficiency of ultrasound-guided trans-vaginal drainage of tubo-ovarian abscesses (TOA) and to study the responsible germs. MATERIAL AND METHODS: All the patients with a larger abscess than 20mm were included prospectively from May 2011 to July 2014 in the university hospital of Lille. RESULTS: Sixty-nine drainages were performed among 50 patients. Success rate was 94%. No complication occurred. One germ was found in 55% of patients, the TOA was polymicrobian in 20% of cases. CONCLUSION: Ultrasound-guided trans-vaginal drainage of TOA is safe and effective with more than 90% of success rate.

Bulky fibroid and pregnancy: myomectomy is possible during pregnancy.

When bulky fibroids are discovered during pregnancy, they can become acutely complicated. The question of their resection thus arises. The authors report a case of a woman who was diagnosed at eight weeks' gestation by ultrasound and then by MRI, with a uterine fibroma measuring 22x12x15 cm.

Evaluation of tubal microinserts position using 3D ultrasound and pelvic X-ray.

PURPOSE: To retrospectively compare three-dimensional ultrasonography (3D-US) and pelvic X-rays to assess the position of tubal sterilization microinserts. MATERIAL AND METHODS: Forty-four patients who underwent tubal sterilization with Essure(®) microinserts in our institution were included. The microinserts'position was evaluated three months after the procedure using 3D-US and pelvic X-rays. Placement on 3D-US was binary categorized as correct or incorrect and the distance between the two devices was reported. The orientation and symmetric deployment of the microinserts and the distance between the proximal parts of the two devices was assessed on pelvic X-rays. Performance of 3D-US and pelvic X-ray were compared using Mac Nemar test. Comparison of the distance between the two devices measured on pelvic X-rays and 3D-US was made with the paired Student t test. RESULTS: 3D-US images showed microinserts in 93% (41/44). Eighty-six percent (38/44) were correctly positioned on 3D-US and 82% (36/44) on pelvic X-rays. No significant differences between the performances of the two imaging techniques were found. No significant differences for the distance between the two devices measured on pelvic X-ray and 3D-US was found. CONCLUSION: 3D-US is a simple, non-ionizing technique, which appears as a promising alternate technique to pelvic X-rays to assess the correct position of Essure(®) microinserts.

[Hedrocele, an unknown pelvic organ prolapse]. / Mise au point sur l'hédrocèle, un trouble de la statique pelvienne méconnu.

Pelvic floor disorders are frequent and source of symptoms which can be invalidating for patients. Between them, hedrocele is a pathology often unknown and clinically difficult to diagnose. It is a herniation of fat pad, small bowel or sigmoid colon in the recto-uterine pouch (cul-de-sac of Douglas) exercising a mass effect on the anterior wall of the rectum. Pelvic magnetic resonance imaging with morphological sequences and dynamic sequences in thrust can be very useful, allowing a comprehensive study of pelvic floor dysfunction and confirming the complete diagnosis, especially before surgery. We suggest you some examples to illustrate this pathology in order to emphasize the importance of its diagnosis, especially preoperative. A better understanding of this pelvic floor dysfunction would improve the care of patients.

[Pudendal nerve block for perineo-vulvar surgery: monocentered prospective and randomised study]. / Bloc du nerf pudendal en chirurgie périnéo-vulvaire : étude monocentrique prospective randomisée.

OBJECTIVES: Evaluation of pudendal nerve block on the quality of analgesia in perineal or vulvar surgery. PATIENTS AND METHODS: We realised a monocentered, prospective and randomised study of all patients undergoing perineo-vulvar surgery. Two groups of patients were evaluated: general anaesthesia alone (GA group, 41 patients) and both general anaesthesia and bilateral nerve stimulator-guided pudendal nerve block (15 mL of Ropivacaïne 5 mg.mL(-1)+0,5 µg.kg(-1) of Clonidine) (PB group, 42 patients). Evaluation of pain was realised with per- and post-surgical prescription of hypnotics and antalgics was noted. The primary outcome measure was the Visual Analogic Scale (VAS) pain means scores in the first postoperative 24 hours. RESULTS: There was no difference in the VAS pain means scores in the first 24 hours, but it seemed to have a decrease in VAS pain at 2 hours in the PB group. Analgesic consumption during surgery was decreased in the same group. No complication of the pudendal block has been reported. DISCUSSION AND CONCLUSION: The nerve stimulator-guided pudendal nerve block is a simple and useful method which can, when associated with general anesthesia, reduce per-operative antalgics consumption and a decrease in the immediate postoperative pain in perineal or vulvar surgery, without complication or lengthening operating time. Further studies are needed to confirm the effectiveness of this technique and evaluate the costs and potential complications.

Pelvic endometriosis in women under 25: a specific management?

AIM: The aim of this study was to describe the characteristics of women under 25 years with pelvic endometriosis and assess their potential for recurrence and fertility after surgery. METHODS: In a comparative retrospective study, 108 patients aged less than 25 years who underwent surgery for pelvic endometriosis were included: 49 in the DIE group (deep infiltrating endometriosis) and 59 in the SE group (superficial endometriosis). The main outcome measures were complications, recurrence and fertility. This study received the favorable opinion of the CEROG No 2012-GYN-04-02. RESULTS: The diagnosis was made at 21.6 ± 2.8 years, mainly considering clinical signs (78.4%), and on average 4.3 ± 3.7 years after the onset of symptoms; 16.1% of patients had to be reoperated (N.=5/31) due to a recurrence of their endometriosis. There were more recurrent pain (50% vs. 21.7%, P=0.005) and endometriosis (35.7 vs. 19.6%, P=0.08) in the DIE group. 75% (N.=33/44) patients desired pregnancy after surgery and 50% of them became pregnant, with one third thanks to assisted reproductive technology. CONCLUSION: In young women, endometriosis is often more severe. The early treatment does not improve the rate of recurrence and fertility, but can reduce pain and thus improve the quality of life.

How to manage peroperative haemorrhage when vaginally treating genital prolapse.

Surgery of genital prolapse causes haemorrhagic complications in about 1% of cases. The pelvis is highly vascular and accessing the usual landmarks of vaginal surgery, in particular the sciatic spine, is delicate work. Meticulous dissection of closed spaces is often difficult, and exposure and haemostatic procedures will be challenging in the event of any bleeding complication. When fixing prosthesis to the sacrospinous ligament, the inferior gluteal artery and its coccygeal branch are at risk. Fixation to the sacrospinous ligament must be performed more than 25mm away from the sciatic spine and, if possible, must not transfixiate it. Safe insertion of prosthesis requires sufficient experience, and an adequate learning curve. Being aware of vascular anatomy allows one to understand and treat haemorrhagic incidents. Packing or selective embolization seem to be the two methods to adopt, depending on the severity of bleeding and the conditions of exposure on the one hand, and on the technical resources available for embolization, on the other. Hypogastric ligature appears to be ineffective in this context.