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.

[Urogynecology pelvic organ prolapse French surgical training during and after residency]. / Formation des internes et jeunes assistants de gynécologie-obstétrique en statique pelvienne en France.

OBJECTIVES: For the treatment of prolapse, the vaginal route is less standardized than laparoscopy and seems abandoned by younger doctors. Our objectives were to evaluate the surgical experience of resident and youth gynecology and obstetrics assistants in pelviperineology and the level of confidence and mastery of the different surgical treatment of pelvic. METHODS: An anonymous questionnaire sent via an Internet platform interviewing residents and young assistants of gynecology and obstetrics (promotion 2005 to 2010) in France on their surgical training in pelviperineology. RESULTS: Twenty-nine percent (208/724) of the persons contacted responded with two thirds of residents and one third of young assistants, all regions of France were represented. Sixty-four percent of respondents wanted to favor a surgical career. The laparoscopic sacrocolpopexy was declared to be the best method mastered while residents and young assistants reported being more often leading operator in vaginal techniques during their medical training. CONCLUSION: Surgical practice during medical training of resident and young assistants did not seem associated with declared mastery level of technique. Different clinical surgical practice training techniques such as simulation, cadaveric study, movies on surgical technics may also improve the level of confidence and mastery of young doctors for surgical techniques.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical effectiveness and complication rates at 5 years following the total Trans Vaginal Mesh (TVM) technique to treat pelvic organ prolapse. METHODS: Prospective, observational, multi-centre study in patients with prolapse of stage II or higher. RESULTS: Of the 90 women enrolled in the study, 82 (91%) were available for the 5-year follow-up period. At the 5-year endpoint, success, defined as no surgical prolapse reintervention and leading edge <-1 (International Continence Society [ICS] criteria) or above the level of the hymen, was 79% and 87% respectively. A composite criterion of success defined as: leading edge above the hymen (<0) and no bulge symptoms and no reintervention for prolapse was met by 90%, 88% and 84% at the 1-, 3-, and 5-year endpoints respectively. Quality of life improvement was sustained over the 5 years. Over the 5-year follow-up period, a total of only 4 patients (5%) required re-intervention for prolapse, while a total of 14 patients (16%) experienced mesh exposure for which 8 resections needed to be performed. Seven exposures were still ongoing at the 5-year endpoint, all asymptomatic. Only 33 out of 61 (54%) sexually active patients at baseline remained so at 5 years. De novo dyspareunia was reported by 10%, but no new cases at the 5-year endpoint. One patient reported de novo unprovoked mild pelvic pain at 5 years, 5 reported pains during pelvic examination only. CONCLUSIONS: Five-year results indicated that TVM provided a stable anatomical repair. Improvements in QOL and associated improvements in prolapse-specific symptoms were sustained. Minimal new morbidity emerged between the 1- and 5-year follow-up.

[PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. / Étude randomisée comparant la promontofixation cœlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair).

BACKGROUND: Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages: easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes. METHOD/DESIGN: The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies.

[Functional results following transobturator and retropubic mid-urethral sling]. / Résultats fonctionnels de la chirurgie de l'incontinence urinaire à l'effort par bandelette sous-urétrale par voie rétropubienne et transobturatrice.

OBJECTIVE: To compare functional results following retropubic and transobturator mid-urethral sling procedures. METHODS: Multicenter randomized controlled trial. Power calculation was based on the rate of bladder injury. The current study concerns an analysis of secondary judgment criteria. RESULTS: One hundred and forty-nine patients were randomly allocated to either TVT (n=75) or TVT-O (n=74). Among them, 132 women completed a 24-month follow-up. There was no significant difference between the two groups, concerning urodynamics data (excluding uroflowmetry) at 12 months follow-up, functional and sexual results at 6, 12 and 24 months follow-up. Concerning sexual results, an improvement in visual analogue scale scores was observed in both groups at 24 months follow-up with no difference between the two groups: median score increased from 70 (IQR: 50-80) pre-operatively to 90 (IQR: 70-100) at 24 months follow-up (P=0,0004) in TVT-O group and from 70 (IQR: 50-80) to 85 (IQR: 70-100) (P=0,0009) in TVT group. CONCLUSION: TVT and TVT-O procedures are both associated with an increase in quality of life with no significant differences in functional results at 2 years follow-up.

[Not Available]. / Place du curage lombo-aortique et pelvien dans les cancers épithéliaux de l'ovaire.

D. Salet-Lizée, S. Alsary Ovarian cancer often invades regional lymph nodes but the patterns of involvement are variable; spread to para-aortic and pelvic lymph nodes can be unilateral, contralateral or bilateral. For staging purposes, complete lymph node dissection seems more reasonable and effective than simple lymph node sampling. In early stage disease, lymph node dissection has both diagnostic and therapeutic value allowing identification and optimal management of Stage IIIc tumors with retroperitoneal spread; it may also have direct therapeutic value by removing retroperitoneal micrometastatic disease including cell clones which may be resistant to chemotherapy. Therefore, complete lymph node dissection is recommended in early-stage disease with the exception of stage I mucinous ovarian cancer. In advanced-stage disease, lymph node involvement is an additional factor of poor prognosis correlating with increased tumor aggressivity. Optimal debulking resection of all visible tumor offers the best chance for a prolonged disease-free interval if patient condition permits and morbidity can be limited. Survival benefit for complete lymph node dissection has not been evaluated by randomized controlled trials; but several non-randomized studies and two long-term prospective trials have shown objective improvement in disease-free survival and improved quality of life when debulking surgery leaves no residual tumor larger than 1 cm.

[Not Available]. / Place du curage lombo-aortique et pelvien dans les cancers épithéliaux de l'ovaire.

D. Salet-Lizée, S. Alsary Ovarian cancer often invades regional lymph nodes but the patterns of involvement are variable; spread to para-aortic and pelvic lymph nodes can be unilateral, contralateral or bilateral. For staging purposes, complete lymph node dissection seems more reasonable and effective than simple lymph node sampling. In early stage disease, lymph node dissection has both diagnostic and therapeutic value allowing identification and optimal management of Stage IIIc tumors with retroperitoneal spread; it may also have direct therapeutic value by removing retroperitoneal micrometastatic disease including cell clones which may be resistant to chemotherapy. Therefore, complete lymph node dissection is recommended in early-stage disease with the exception of stage I mucinous ovarian cancer. In advanced-stage disease, lymph node involvement is an additional factor of poor prognosis correlating with increased tumor aggressivity. Optimal debulking resection of all visible tumor offers the best chance for a prolonged disease-free interval if patient condition permits and morbidity can be limited. Survival benefit for complete lymph node dissection has not been evaluated by randomized controlled trials; but several non-randomized studies and two long-term prospective trials have shown objective improvement in disease-free survival and improved quality of life when debulking surgery leaves no residual tumor larger than 1 cm.

[The place of lumo-aortic and pelvic lymph node dissection in the treatment of ovarian cancer]. / Place du curage lombo-aortique et pelvien dans les cancers épithéliaux de l'ovaire.

Ovarian cancer often invades regional lymph nodes but the patterns of involvement are variable; spread to para-aortic and pelvic lymph nodes can be unilateral, contralateral or bilateral. For staging purposes, complete lymph node dissection seems more reasonable and effective than simple lymph node sampling. In early stage disease, lymph node dissection has both diagnostic and therapeutic value allowing identification and optimal management of Stage IIIc tumors with retroperitoneal spread; it may also have direct therapeutic value by removing retroperitoneal micrometastatic disease including cell clones which may be resistant to chemotherapy. Therefore, complete lymph node dissection is recommended in early-stage disease with the exception of stage I mucinous ovarian cancer. In advanced-stage disease, lymph node involvement is an additional factor of poor prognosis correlating with increased tumor aggressivity. Optimal debulking resection of all visible tumor offers the best chance for a prolonged disease-free interval if patient condition permits and morbidity can be limited. Survival benefit for complete lymph node dissection has not been evaluated by randomized controlled trials; but several non-randomized studies and two long-term prospective trials have shown objective improvement in disease-free survival and improved quality of life when debulking surgery leaves no residual tumor larger than 1 cm.

[TVT-O treatment of stress urinary incontinence: immediate and one-year results]. / Traitement de l'incontinence urinaire d'effort par bandelette TVT-O: résultats immédiats et à un an.

OBJECTIVE: To compare one-year results between the classic retropupubic (TVT) and the in-out transobturator approaches (TVT-O) of tension-free vaginal tape for the treatment of stress urinary incontinence (SUI). PATIENTS AND METHODS: The first 82 patients operated for SUI by TVT-O in our institution were included in the analysis. Patients were evaluated at 1 and 12 months. The global satisfaction rate was assessed at 12 months by a self-reported questionnaire. Results were compared to those of the first 124 patients operated of SUI by TVT in the same institution and by the same surgeons between 1996 and 1999. RESULTS: Except a younger mean age in the TVT-O group (57 versus 60 years), no other preoperative parameter was significantly different between the TVT and the TVT-O groups. The mean operating time was shorter in the TVT-O group (15 versus 30 minutes, P<0.001). No intraoperative complication occurred. The rate of bladder perforation was significantly lower in the TVT-O group (0 versus 8.8%, P=0.004). The rate of post-voiding residual less than 100 ml was higher in the TVT-O group (88 versus 61%, P<0.001). In the TVT-O group, 40% of patients had postoperative inguinal pain (mean=9 days, range 2-15 days). After 12 months from TVT-O, 85% of patients were completely dry, 6% had de novo over bladder activity, and 93.5% of patients were satisfied with the treatment they received. The 12-month results were not significantly different between the TVT and the TVT-O groups. DISCUSSION AND CONCLUSION: With a follow-up of 12 months, TVT-O is as efficient as TVT and has a lower risk of bladder injury, a cut by half operating time, and less postoperative dysuria.

[Endometrial choriocarcinoma in peri-menopausal women]. / Choriocarcinome utérin en péri-ménopause.

We report a case of a primary uterine choriocarcinoma associated with adenocarcinoma occurring during peri-menopausal age, and review the literature. The clinical course and the histopathology of the case were reviewed and a Medline literature search for other cases was performed. BHCG and analysis of uterine curettage provided the diagnosis of choriocarcinoma. Polychemotherapy, started immediately after the patient's clinical condition deteriorated, was successful. Colpohysterectomy and pelvic lymphadenectomy were performed 5 months later. Treatment was completed by vaginal curietherapy. Histopathologic examination of the surgical specimen revealed only adenocarcinoma. The patient was followed for 18 months without evidence of recurrence. The literature search revealed that primary forms are exceptional; the etiology is unknown. Treatment is based on polychemotherapy. Primary choriocarcinomas are rare tumours, associated with other histopathological forms. We document a case occurring during the peri-menopausal period and review the literature on this pathology. The very poor prognosis in the past has changed with early polychemotherapy.

[Changing attitudes on the surgical treatment of urogenital prolapse: birth of the tension-free vaginal mesh]. / Evolution des idées sur le traitement chirurgical des prolapsus génitaux: naissance de la technique TVM.

OBJECTIVES: To describe, in view of the new standardization, the technique for urogenital prolapse repair using a one-piece synthetic mesh. MATERIALS AND METHODS: The history and development steps through which the Tension free Vaginal Mesh (TVM) technique emerged are described. The use of a mesh was prompted by the 20-30% recurrence rate associated with conventional repair techniques. Selection of the type of mesh is discussed. Non-absorbable synthetic meshes have shown their usefulness in visceral surgery. A list of materials along with their respective advantages and inconveniences is reviewed and particular emphasis is put on both the tolerance and erosion issues, the latter being specific to the vaginal route. The TVM Group selected a one-thread polypropylene mesh, Prolene Soft, which seemed the most appropriate for the transvaginal approach of prolapse surgical repair. The prosthesis and its design rationale are described. Full details are given on the consecutive intervention steps and underlying concepts. RESULTS: The relevant literature is scarce and there is a lack of methodologically sound studies validating the materials and techniques used. After completion of a first step of technique refinement and feasibility assessment involving about 300 surgical interventions, the authors initiated a prospective multicenter study. Clinical outcome assessments using feasibility, complications, and efficacy endpoints will be published after twelve months, three years, and five years of follow-up. CONCLUSION: Fruitful reasoning led to the development of the TVM technique of complete surgical repair of genital prolapse, which uses a synthetic materiel carefully selected after several tests. All surgeons can apply this technique after a short training period.

[Clinical management of non palpable breast lesions: experience about a series of 176 consecutive cases]. / Prise en charge des lésions infracliniques du sein : expérience à propos de 176 cas consécutifs.

OBJECTIVE: To propose a rational attitude to treat infraclinic breast lesions about a 176-case retrospective analysis. PATIENTS AND METHODS: Between January and December 2000, 176 patients were addressed for an infraclinic breast lesion. The epidemiologic and mammographic data, diagnostic management and histological results were collected. RESULTS: Patients were addressed for an ACR 2 lesion in 0.8% of cases, ACR 3: 34.8%, ACR 4: 43.2% and ACR 5: 21.2%. One hundred and sixteen patients underwent a stereotactic macrobiopsy: 55 Advanced Breast Biopsy Instrumentation (ABBI), 61 Minimal Invasive Breast Biopsy (MIBB). Histologically, 59.5% were benign, 33.6% malignant, 2.6% borderline and 4.3% suspicious or non contributive. Forty-two patients underwent an open surgical biopsy. Histologically 56.1% were benign, 41.5% malignant and 2.4% borderline. Eighteen patients were controlled by mammography. Among ACR 3s there were 90% of benign lesions and 46% of malignancy in ACR 4s. Patients with malignant, borderline or suspicious result in stereotactic biopsy, underwent one-time surgery in 97% vs 55% in surgical biopsy (P < 0.0001). DISCUSSION AND CONCLUSION: Infraclinic breast lesions must be radiologically classified with the ACR classification. Stereotactic macrobiopsies are reserved for ACR 4 and ACR 5 lesions. Because of their reliability, practice of macrobiopsies avoids surgery in about 50% of ACR 4 lesions which correspond to benign lesions. When the result is malignant, it allows most of times surgical procedure one-time.

Comparison of anterior colporrhaphy versus Bologna procedure in women with genuine stress incontinence.

The aim of the study was to compare the anterior colporrhaphy and the Bologna operation for the treatment of anterior vaginal wall prolapse associated with genuine urinary incontinence (GSI). Sixty-two women undergoing surgery for GSI and concurrent grade 2-3 cystocele were the subjects of the study. Anterior colporraphy was performed on 31 women (group A) and the Bologna operation on another 31 (group B). The mean follow-up was 3 years (range 2-7). Perioperative complications, including urinary tract infections, occurred in 16% of group A versus 42% of group B (P<0.001). Anatomic success regarding the prolapse was, respectively, 92.9% (26/28) and 84.6% (22/26) (P = 0.25). Subjective cure rates of GSI (patient history) were 57.1% in group A (16/28) and 87% in group B (23/26) (P<0.05). Objective cure rates of GSI (negative stress test result) were 53.6% in group A (15/28) and 84.6% in group B (22/26) (P<0.02). We concluded that the Bologna operation was more effective for treating GSI associated with anterior vaginal prolapse than was anterior colporraphy, with an increased rate of morbidity and postoperative urinary retention.