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1.
Article in French | MEDLINE | ID: mdl-38604536

ABSTRACT

OBJECTIVE: To assess clinical and radiological efficacy and safety of laparoscopic ultrasound-guided radiofrequency ablation of uterine leiomyomas. MATERIAL AND METHODS: Thirty-three patients with symptomatic uterine leiomyomas FIGO type 2 to 7, have undergone a laparoscopic ultrasound-guided radiofrequency ablation at Croix Rousse University Hospital Center (Hospices civils de Lyon) and at Saint-Vincent de Paul Hospital in Lille, between June 2020 and December 2022. The characteristics of each myoma and the symptoms were assessed with pelvic MRI and with Higham score, SSS and HRQL scores preoperatively and at 6 months. RESULTS: A total of 54 fibroids have been treated in 33 patients. We observed a significant decrease of the volume 6 months after the surgery, on average 21mL (55.97 vs. 74.37mL, 95% CI [7.13-34.88], P=0.001). The maximum diameter of each fibroid was also significantly reduced on average 11.78mm (41.89 vs. 52.06, 95% CI [8.83-14.73], P<0.05). We noticed a significant decrease of the NRS for dysmenorrhea on average 2.79 points (2.1 vs. 4.89, 95% CI [1.14-4.42], P<0.05). There was also a trend to improvement of menorrhagia, assess by Higham score. Indeed, 70.8% of the patients had menorrhagia. Menorrhagia was improved of 108,3 points with an average Higham score before surgery of 197.3 versus 87.9 after surgery (95% CI [47.9-168.8], P=0.001). Concerning UFS-QOL score: the symptom severity score (SSS) decreased on average 33 points, testifying of symptom improvement (27.04 vs. 60.89, 95% CI [22.92-43.39], P<0.001) and the HRQL score increased on average 20 points testifying quality of life improvement (65.57 vs. 42.7, 95% CI [15.83-37.85]. P<0.001). No severe adverse event has been reported. CONCLUSION: In this first French study about radiofrequency ablation. We confirm its efficiency for improvement of symptoms and quality of life but other study is mandatory to confirm the safety of this procedure in particular in patients with a wish to conceive.

2.
Trials ; 24(1): 759, 2023 Nov 27.
Article in English | MEDLINE | ID: mdl-38012776

ABSTRACT

BACKGROUND: Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which could affect 200 million women (The term "woman" is used for convenience. Individuals gendered as man or as nonbinary can also suffer from this disease) worldwide. One of the most common symptoms of endometriosis is pelvic chronic pain associated with fatigue. This pain can cause psychological distress and interpersonal difficulties. As for several chronic diseases, adapted physical activity could help to manage the physical and psychological symptoms. The present study will investigate the effects of a videoconference-based adapted physical activity combined with endometriosis-based education program on quality of life, pain, fatigue, and other psychological symptoms and on physical activity. METHODS: This multicentric randomized-controlled trial will propose to 200 patients with endometriosis to be part of a trial which includes a 6-month program with 45 min to more than 120 min a week of adapted physical activity and/or 12 sessions of endometriosis-based education program. Effects of the program will be compared to a control group in which patients will be placed on a waiting list. All participants will be followed up 3 and 6 months after the intervention. None of the participants will be blind to the allocated trial arm. The primary outcome measure will be quality of life. Secondary outcomes will include endometriosis-related perceived pain, fatigue, physical activity, and also self-image, stereotypes, motivational variables, perceived support, kinesiophobia, basic psychological need related to physical activity, and physical activity barriers. General linear models and multilevel models will be performed. Predictor, moderator, and mediator variables will be investigated. DISCUSSION: This study is one of the first trials to test the effects of a combined adapted physical activity and education program for improving endometriosis symptoms and physical activity. The results will help to improve care for patients with endometriosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023.


Subject(s)
Endometriosis , Quality of Life , Male , Humans , Female , Endometriosis/diagnosis , Endometriosis/therapy , Endometriosis/complications , Exercise , Pelvic Pain/etiology , Fatigue , Videoconferencing , Exercise Therapy/adverse effects , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
3.
Eur J Obstet Gynecol Reprod Biol ; 264: 155-161, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34303076

ABSTRACT

OBJECTIVE: To review prospectively the clinical characteristics of patients suffering from urinary tract endometriosis (UTE) in France, in 2017. STUDY DESIGN: We conducted a prospective observational multicenter study including women managed surgically for UTE in 31 French endometriosis expert centers (FRIENDS group) from January 1, 2017 to December 31, 2017. We distinguished patient with isolated bladder endometriosis ("IBE") or isolated ureteral endometriosis ("IUE") and patients associating both locations (mixed locations "ML"). Surgeons belonging to FRIENDS group enrolled patients by filling a 24 items questionnaire the day of the surgery and 6 weeks later. Data on the locations of UTE, preoperative assessment, urinary symptoms and associated pelvic locations were collected in a single anonymized database. RESULTS: A total of 232 patients from 31 centers were included. IBE concerned 82 patients (35.3%), IUE 126 patients (54.4%) ML 24 patients (10.3%). 111 patients reported urinary symptoms (47.8%). IUE was more often asymptomatic than the rest of the locations (59.5% versus 43.3%, OR 1,92, p = 0.017). Associated deep infiltrating endometriosis (DIE) lesions were found in 193 patients (83.1%). IUE was significantly associated with other DIE lesions (82.5% versus 66%, OR2.4, p = 0.006), particularly with rectum or sigmoid nodules (57.1% versus 36.8%, OR 2.3, p = 0.002) and retrocervical space nodules (31.7% versus 19.8%, OR 1.9, p = 0.05). CONCLUSION: Our study reports the second largest series of patients operated from a UTE and shows that ureteral location seems more frequent, less symptomatic and more frequently associated to other DIE locations than bladder endometriosis.


Subject(s)
Endometriosis , Laparoscopy , Ureter , Urinary Bladder Diseases , Endometriosis/epidemiology , Endometriosis/surgery , Female , Humans , Urinary Bladder Diseases/epidemiology , Urinary Bladder Diseases/surgery
4.
J Minim Invasive Gynecol ; 28(7): 1384-1390, 2021 07.
Article in English | MEDLINE | ID: mdl-33152532

ABSTRACT

STUDY OBJECTIVE: To study the safety of a degradable polymeric film (DPF) and its efficacy on reducing the risk of intrauterine-adhesion (IUA) formation in a rat model. DESIGN: A series of case-control studies relying on random allocation, where feasible. SETTING: University and good practice animal laboratories. ANIMALS: The animal models comprised female and male Oncins France Strain A and female Wistar rats. INTERVENTION(S) AND MEASUREMENTS: The Oncins France Strain A rats were used for in vivo evaluation of the impact of the DPF on endometrial thickness and its effect on fertility. For in vivo evaluation of the biologic response, 40 Wistar rats were randomly allocated to intervention and control groups, with matched sampling time after surgery. Finally, for the in vivo evaluation of the DPF's efficacy on IUA prevention, a total of 24 Wistar rats were divided into 3 groups: 1 treated with the DPF, 1 treated with hyaluronic acid gel, and a sham group. MAIN RESULTS: The DPF did not have a significant impact on endometrial thickness, and there were no significant differences in the number of conceived or prematurely terminated pregnancies, confirming its noninferiority to no treatment. The DPF did not induce irritation at 5 days and 28 days. Finally, the DPF significantly reduced the likelihood of complete IUA formation compared with hyaluronic acid gel- and sham-implanted animals, where only 27% of the animals had their uterine cavity obliterated compared with 80% and 100%, respectively. CONCLUSION: The DPF is a safe film that is effective in preventing IUA formation after intrauterine curettage in rats.


Subject(s)
Uterine Diseases , Animals , Case-Control Studies , Female , Humans , Hyaluronic Acid , Male , Pregnancy , Rats , Rats, Wistar , Tissue Adhesions/prevention & control , Uterine Diseases/prevention & control
5.
Int J Med Robot ; 16(1): e2059, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31770474

ABSTRACT

OBJECTIVE: To evaluate fertility after robot-assisted laparoscopic myomectomy (RALM) in terms of pregnancy rates, and obstetrical outcomes. PATIENTS: This is a retrospective cohort of RALM performed for symptomatic leiomyomas among women who want to conceive. Medical data were retrospectively reviewed. An office hysteroscopy was prescribed 3 months after the surgery. RESULTS: Fifty-three patients were included. The mean number of myomas was 2 ± 1.5 with a mean size of 69 ± 17.7 mm. A breach of the cavity was noticed in 15.1% of the cases. Two cases of intrauterine adhesions were diagnosed and treated during the post-operative office hysteroscopy (5.7%). Clinical pregnancy rates were 52.8% with a live birth rate of 41.5% in patients desiring pregnancy. A caesarean section was performed in 17 cases (70.8%). No case of uterine rupture was reported. CONCLUSION: More than half of the patients became pregnant after RALM. A low rate of obstetrical complications was reported, with no uterine ruptures, highlighting the promise of this technique for infertile patients.


Subject(s)
Fertility , Pregnancy Complications/epidemiology , Pregnancy Rate , Robotic Surgical Procedures , Uterine Myomectomy , Adult , Female , Humans , Middle Aged , Pregnancy , Retrospective Studies , Robotic Surgical Procedures/adverse effects , Uterine Myomectomy/adverse effects
6.
Neurourol Urodyn ; 38(8): 2255-2263, 2019 11.
Article in English | MEDLINE | ID: mdl-31402478

ABSTRACT

AIMS: To identify differences in the vaginal microbiomes of women after transvaginal mesh (TVM) surgery for pelvic organ prolapse with and without mesh-associated complications. METHODS: Patients with complications were eligible as cases, patients without as controls. DNA was isolated and the V1-2 region of the 16S ribosomal RNA gene was amplified and sequenced. Overall richness was quantified using Chao1. Overall diversity was expressed as Shannon diversity and screened for group differences using analysis of variance. Multivariate differences among groups were evaluated with functions from R. RESULTS: We recruited 14 patients after mesh exposure, 5 after contraction, and 21 as controls. The average number of operational taxonomic unit was 74.79 (SD ± 63.91) for controls, 57.13 (SD ± 58.74) after exposures, and 92.42 (SD ± 50.01) after contractions. Total 89.6% of bacteria in controls, 86.4% in previous exposures, and 81.3% in contractions were classified as either Firmicutes, Proteobacteria, or Actinobacteria (P < .001). Veillonella spp. was more abundant in patients after contraction (P = .045). The individual microbiomes varied, and we did not detect any significant differences in richness but a trend towards higher diversity with complications. CONCLUSIONS: The presence of Veillonella spp. could be associated with mesh contraction. Our study did not identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome of women predisposed to mesh-related complications for targeted phenotyping of patients who could benefit from TVM surgery.


Subject(s)
Microbiota , Postoperative Complications/microbiology , Surgical Mesh , Urologic Surgical Procedures/adverse effects , Vagina/microbiology , Vagina/surgery , Aged , Bacteria , DNA, Bacterial/genetics , DNA, Bacterial/isolation & purification , Female , Humans , Middle Aged , Pelvic Organ Prolapse/surgery , Veillonella
7.
Commun Biol ; 2: 196, 2019.
Article in English | MEDLINE | ID: mdl-31123719

ABSTRACT

Intrauterine adhesions lead to partial or complete obliteration of the uterine cavity and have life-changing consequences for women. The leading cause of adhesions is believed to be loss of stroma resulting from trauma to the endometrium after surgery. Adhesions are formed when lost stroma is replaced by fibrous tissue that join the uterine walls. Few effective intrauterine anti-adhesion barriers for gynecological surgery exist. We designed a degradable anti-adhesion medical device prototype to prevent adhesion formation and recurrence and restore uterine morphology. We focused on ideal degradation time for complete uterine re-epithelialization for optimal anti-adhesion effect and clinical usability. We developed a triblock copolymer prototype [poly(lactide) combined with high molecular mass poly(ethylene oxide)]. Comparative pre-clinical studies demonstrated in vivo anti-adhesion efficacy. Ease of introduction and optimal deployment in a human uterus confirmed clinical usability. This article provides preliminary data to develop an intrauterine medical device and conduct a clinical trial.


Subject(s)
Equipment Design , Tissue Adhesions/prevention & control , Uterine Diseases/metabolism , Uterus/pathology , Uterus/surgery , Adult , Animals , Cell Adhesion , Collagen , Endometrium/pathology , Female , Humans , In Vitro Techniques , Magnetic Resonance Spectroscopy , Polyesters/chemistry , Polyethylene Glycols/chemistry , Random Allocation , Rats , Rats, Wistar , Recurrence , Viscosity
8.
PLoS One ; 13(11): e0202285, 2018.
Article in English | MEDLINE | ID: mdl-30395571

ABSTRACT

BACKGROUND: Peritoneal adhesions are a serious surgical postoperative complication. The aim of this study is to investigate, in a rat model, the anti-adhesive effects of a bioabsorbable film of polymer combining polyethylene glycol and polylactic acid. MATERIALS AND METHODS: Sixty-three animals were randomized into five groups according to the anti-adhesion treatment: Hyalobarrier®, Seprafilm®, Polymer A (PA), Polymer B (PB), and control. The rats were euthanized on days 5 and 12 to evaluate the extent, severity and degree of adhesions and histopathological changes. Three animals were euthanized at day 2 in PA, PB and control groups to observe the in vivo elimination. RESULTS: Macroscopic adhesion formation was significantly lower in the PA group than in the control group at day 5 (median adhesion score 0±0 vs 9.6 ±0.5 p = 0.002) and at day 12 (0±0 vs 7.3±4 p = 0.02). Furthermore, median adhesion score at day 5 was significantly lower in the PA group than in the Seprafilm group (0±0 vs 4.2± 3.9 p = 0.03). Residence time of PA seems longer than PB. CONCLUSION: The PA bioabsorbable film seems efficient in preventing the formation of peritoneal adhesions.


Subject(s)
Biodegradable Plastics/pharmacology , Membranes, Artificial , Polyesters/pharmacology , Polyethylene Glycols/pharmacology , Tissue Adhesions/prevention & control , Animals , Disease Models, Animal , Female , Peritoneum/pathology , Peritoneum/surgery , Rats , Tissue Adhesions/pathology
9.
Int Urogynecol J ; 28(8): 1139-1151, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28150032

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The use of mesh in pelvic organ prolapse (POP) surgery has become a widespread treatment option, but carries a risk of specific complications. The objective was to report the rate and type of reoperation for mesh-related complications after pelvic organ prolapse surgery in an urogynecological referral center over a period of 8 years. METHODS: A retrospective study was carried out including all patients operated for a mesh complication after prolapse surgery between September 2006 and September 2014 in the urogynecology unit in Nîmes hospital. RESULTS: Sixty-nine mesh complications were recorded among the 67 patients included. Surgical treatment of mesh-related complications accounted for 7% of all pelvic surgeries performed in our center. Thirty-two patients (47.8%) were referred from other centers and 35 patients (52.2%) were initially operated in our unit. The global rate of reintervention for mesh-related complications after prolapse repair performed in our unit was 2.8%. Of 69 mesh complications, 48 patients (71.6%) had transvaginal mesh (TVM) and 19 patients (28.4%) sacrocolpopexy (SCP). The indication for surgery was a symptomatic or large vaginal erosion (47.8%), symptomatic mesh contraction (20.3%), and infection (11.6%). The most frequent primary symptom was pelvic/perineal pain or dyspareunia (33.3% of cases). The mean time between initial mesh surgery and the reoperation for a complication was 33.4 months (95% CI, 24.5 to 42.2). Eleven patients (15.9%) required several interventions. In total, 77.9% of patients experienced complete recovery of symptoms after surgical management. CONCLUSION: In a referral center the global rate of reinterventions for mesh-related complications after POP repair is 2.8%. The surgical treatment of mesh complications appears to be a safe and effective procedure with cure of the symptoms in most cases.


Subject(s)
Pelvic Organ Prolapse/surgery , Postoperative Complications/surgery , Reoperation/statistics & numerical data , Surgical Mesh/adverse effects , Adult , Aged , Aged, 80 and over , Dyspareunia/etiology , Dyspareunia/surgery , Female , Humans , Middle Aged , Pelvic Pain/etiology , Pelvic Pain/surgery , Postoperative Complications/etiology , Retrospective Studies , Tertiary Care Centers , Treatment Outcome , Vagina/surgery
10.
BMC Womens Health ; 16: 21, 2016 05 03.
Article in English | MEDLINE | ID: mdl-27142415

ABSTRACT

BACKGROUND: Carcinoma of the recto-vaginal septum is a quite rare location and related to peritoneal and primary ovarian carcinomas. There are only few reports in the literature with a very poor prognosis. CASE PRESENTATION: Here we report the case of a 63 years old woman with past medical history of left oophorectomy presenting with a pelvic pain. The magnetic resonance imaging (MRI) demonstrated a 10 cm mass located in the recto-vaginal septum. A block resection was performed allowing the retrieval of a 10 cm solid tumor of the recto-vaginal septum. Peritoneal biopsies and the right ovary were normal the final diagnosis was cystadenocarcinoma of the recto-vaginal septum. The patient received adjuvant chemotherapy and displays no sign of recurrence 36 months after diagnosis. CONCLUSION: The management of recto-vaginal septum carcinoma with en bloc resection should be performed to avoid peritoneal spread and improve prognosis.


Subject(s)
Cystadenocarcinoma/physiopathology , Vaginal Neoplasms/surgery , Adnexal Diseases/complications , Adnexal Diseases/etiology , Bevacizumab/pharmacology , Bevacizumab/therapeutic use , Carboplatin/pharmacology , Carboplatin/therapeutic use , Cystadenocarcinoma/diagnosis , Cystadenocarcinoma/epidemiology , Dyslipidemias/etiology , Female , Humans , Hysterectomy/methods , Middle Aged , Pain/etiology , Prognosis , Vaginal Neoplasms/physiopathology
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