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1.
Front Med (Lausanne) ; 11: 1382609, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39219795

RESUMEN

Introduction: The curriculum for a da Vinci surgeon in gynecology requires special training before a surgeon performs their first independent case, but standardized, objective assessments of a trainee's workflow or skills learned during clinical cases are lacking. This pilot study presents a methodology to evaluate intraoperative surgeon behavior in hysterectomy cases through standardized surgical step segmentation paired with objective performance indicators (OPIs) calculated directly from robotic data streams. This method can provide individual case analysis in a truly objective capacity. Materials and methods: Surgical data from six robot-assisted total laparoscopic hysterectomies (rTLH) performed by two experienced surgeons was collected prospectively using an Intuitive Data Recorder. Each rTLH video was annotated and segmented into specific, functional surgical steps based on the recorded video. Once annotated, OPIs were compared through workflow analysis and across surgeons during two critical surgical steps: colpotomy and vaginal cuff closure. Results: Through visualization of the individual steps over time, we observe workflow consistencies and variabilities across individual surgeons of a similar experience level at the same hospital, creating unique surgeon behavior signatures across each surgical case. OPI differences across surgeons were observed for both the colpotomy and vaginal cuff closure steps, specifically reflecting camera movement, energy usage and clutching behaviors. Comparing colpotomy and vaginal cuff closure time needed for the step and the events of energy use were significantly different (p < 0.001). For the comparison between the two surgeons only the event count for camera movement during colpotomy showed significant differences (p = 0.03). Conclusion: This pilot study presents a novel methodology to analyze and compare individual rTLH procedures with truly objective measurements. Through collection of robotic data streams and standardized segmentation, OPI measurements for specific rTLH surgery steps can be reliably calculated and compared to those of other surgeons. This provides opportunity for critical standardization to the gynecology field, which can be integrated into individualized training plans in the future. However, more studies are needed to establish context surrounding these metrics in gynecology.

2.
Geburtshilfe Frauenheilkd ; 84(3): 256-263, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38455998

RESUMEN

Introduction: Changes in surgical practice patterns to cure stress urinary incontinence (SUI) became evident after FDA warnings regarding vaginal mesh were issued. The primary aim was to describe nationwide numbers of suburethral alloplastic slings (SAS) inserted in 2010, 2015, 2018 and 2021 in Germany. Secondary, numbers were related to SUI specific non-alloplastic alternatives and bulking agents. Additionally, age distribution and overall inpatient surgeries in women were subject to analysis. Materials and Methods: Descriptive study utilizing data gathered from the German Federal Statistical Office ( www.destatis.de ). Included were the following procedures of inpatient surgery: A. SAS; B. non-allplastic slings; C. open/laparoscopic colposuspension; D. Bulking agents; overall changes and changes in age distribution (groups of 5-years intervals) are described. Results: Overall, n = 3599466 female inpatient procedures were analyzed. There was a considerable decrease of SAS surgeries of 28.49% between 2010 (n = 23464) and 2015 (n = 16778), and a decrease of 12.42% between 2015 and 2018 (n = 14695) and an additional decrease of 40.66% between 2018 and 2021 (n = 8720). Over time a 55.03% continuous decrease in non-alloplastic slings was observed (n = 725 in 2010 to n = 326 in 2021). Open and laparoscopic colposuspension numbers went down with a rate of 58.23% (n = 4415 in 2010, n = 1844 in 2021). Between 2010 and 2018, only bulking agent procedures increased with a rate of 5.89% from n = 1425 to n = 1509. Conclusions: There was a considerable decrease in inpatient surgical procedures using SAS. Alternatives not only failed to compensate, but experienced also a major decline.

3.
Surg Endosc ; 37(7): 5215-5225, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-36952046

RESUMEN

BACKGROUND: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. METHODS: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons' characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. RESULTS: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. CONCLUSION: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.


Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Cirugía Plástica , Humanos , Diafragma Pélvico/cirugía , Técnica Delphi , Procedimientos Quirúrgicos Robotizados/métodos , Laparoscopía/métodos
4.
Arch Gynecol Obstet ; 307(3): 849-862, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36401096

RESUMEN

PURPOSE: Conventional laparoscopic surgery (CLS) imposes an increased risk of work-related musculoskeletal disorders. Technical innovations, such as robotic-assisted laparoscopic surgery (RALS), may provide ergonomic benefits. We compare the surgeon`s work-related demands of CLS vs RALS for benign hysterectomies. METHODS: Five specialists (3 females, 2 males) each performed four RALS and four CLS as part of their daily clinical routine. During the surgical procedures, muscular demands were assessed by bipolar surface electromyograms of the descendent trapezius, extensor digitorum and flexor carpi radialis muscles as well as cardio-vascular demands by electrocardiography, and neck, arm and torso posture by gravimetrical position sensors. Additionally, the subjects rated their level of perceived workload (NASA TLX questionnaire with 6 dimension) and musculoskeletal discomfort (11-point Likert-scale, 0-10). RESULTS: Muscular demands of the trapezius and flexor carpi radialis muscles were lower with RALS but extensor digitorum demands increased. Cardiovascular demands were about 9 heart beats per minute (bpm) lower for RALS compared to CLS with a rather low median level for both surgical techniques (RALS = 84 bpm; CLS 90 bpm). The posture changed in RALS with an increase in neck and torso flexion, and a reduction in abduction and anteversion position of the right arm. The perceived workload was lower in the physical demands dimension but higher in the mental demands dimension during RALS. Subjective musculoskeletal discomfort was rare during both surgical techniques. CONCLUSIONS: This explorative study identified several potential ergonomic benefits related to RALS which now can be verified by studies using hypothesis testing designs. However, potential effects on muscular demands in the lower arm extensor muscles also have to be addressed in such studies.


Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Cirujanos , Masculino , Femenino , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Carga de Trabajo , Electromiografía , Laparoscopía/métodos , Postura
5.
J Clin Med ; 11(17)2022 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-36078957

RESUMEN

The objective of this case series was to describe different uterus-preserving surgical approaches and outcomes in patients with complex obstructive Müllerian duct malformation caused by cervical and/or vaginal anomalies. A retrospective analysis was performed including patients undergoing uterovaginal anastomosis (n = 6) or presenting for follow-up (n = 2) at the Department for Gynecology at the University of Tuebingen between 2017 and 2022. Uterovaginal anastomosis was performed with a one-step combined vaginal and laparoscopic approach (method A), a two-step/primary open abdominal approach with primary vaginal reconstruction followed by abdominal uterovaginal anastomosis after vaginal epithelization (method B) or an attempted one-step approach followed by secondary open abdominal uterovaginal anastomosis due to reobstruction (method A/B). Patients presented at a mean age of 15 years. Two patients were treated by method A, four by method B and two by method A/B. Functional anastomosis was established in seven of eight patients, with normal vaginal length in all patients. Concerning uterovaginal anastomosis, the primary open abdominal approach with or without previous vaginal reconstruction seems to have a higher success rate with fewer procedures and should be implemented as standard surgical therapy for complex obstructive genital malformations including the cervix.

7.
Int Urogynecol J ; 33(2): 411-419, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34100975

RESUMEN

INTRODUCTION AND HYPOTHESIS: The purpose of the study was to analyze anatomical and functional outcomes after sacrocolpopexy (SCP) for vaginal vault prolapse pelvic organ prolapse quantification (POPQ) II-III by random use of absorbable (Vicryl) and non-absorbable sutures (Ethibond) for vaginal mesh fixation. METHODS: This study was designed as a two-center randomized controlled study (RCT). The primary objective was to evaluate the anatomical outcome. Success was defined when the vaginal apex (point C; POPQ) did not descend more than 50% of the total vaginal length (tvl) during Valsalva. Patients completed a pelvic examination incorporating the POPQ and questionnaires (the German pelvic floor questionnaire and the PISQ-12 questionnaire) at baseline and 6 months postsurgery. Perioperative adverse events (AE) were recorded. Sample size calculations, based on a 10% non-inferiority limit required 100 participants per group, with power = 90%. RESULTS: In 190 out of 195 women (ETH group n = 96; VIC group n = 94) anatomical success was achieved. The relative risk of anatomical success failure in the VIC group versus the ETH group was 0.69, with a 95% confidence interval 0.12-4.02. The change in the symptom scores did not differ significantly between the ETH and the VIC group. In the ETH group, three suture penetrations into the vagina were observed, and none in the VIC group 6 months postoperatively. CONCLUSIONS: Anatomical success after SCP for vaginal vault prolapse POPQ II-III is not affected by suture type for vaginal monofilament mesh attachment. Moreover, we did not see any differences in functional outcomes between the two groups. Three suture penetrations into the vagina were observed in the ETH group, and none in the VIC group 6 months postoperatively.


Asunto(s)
Prolapso de Órgano Pélvico , Mallas Quirúrgicas , Femenino , Procedimientos Quirúrgicos Ginecológicos , Humanos , Prolapso de Órgano Pélvico/cirugía , Mallas Quirúrgicas/efectos adversos , Suturas/efectos adversos , Resultado del Tratamiento , Vagina/cirugía
8.
Arch Gynecol Obstet ; 304(6): 1519-1526, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34453213

RESUMEN

PURPOSE: The rates of hysterectomy are falling worldwide, and the surgical approach is undergoing a major change. To avoid abdominal hysterectomy, a minimally invasive approach has been implemented. Due to the increasing rates of subtotal hysterectomy, we are faced with the following questions: how often does the cervical stump have to be removed secondarily, and what are the indications? METHODS: This was a retrospective, single-centre analysis of secondary resection of the cervical stump conducted from 2004 to 2018. RESULTS: Secondary resection of the cervical stump was performed in 137 women. Seventy-four percent of the previous subtotal hysterectomy procedures were performed in our hospital, and 26% were performed in an external hospital. During the study period, 5209 subtotal hysterectomy procedures were performed at our hospital. The three main indications for secondary resection of the cervical stump were prolapse (31.4%), spotting (19.0%) and cervical dysplasia (18.2%). Unexpected histological findings (premalignant and malignant) after subtotal hysterectomy resulted in immediate (median time, 1 month) secondary resection of the cervical stump in 11 cases. In four patients, the indication was a secondary malignant gynaecological disease that occurred more than 5 years after subtotal hysterectomy. The median time between subtotal hysterectomy and secondary resection of the cervical stump was 40 months. Secondary resection of the cervical stump was performed vaginally in 75.2% of cases, laparoscopically in 20.4% of cases and abdominally in 4.4% of cases. The overall complication rate was 5%. CONCLUSION: Secondary resection of the cervical stump is a rare surgery with a low complication rate and can be performed via the vaginal or laparoscopic approach in most cases. The most common indications are prolapse, spotting and cervical dysplasia. If a secondary resection of the cervical stump is necessary due to symptoms, 66.6% will be performed within the first 6 years after subtotal hysterectomy.


Asunto(s)
Histerectomía , Metrorragia , Femenino , Humanos , Estudios Retrospectivos
9.
BMC Womens Health ; 21(1): 52, 2021 02 05.
Artículo en Inglés | MEDLINE | ID: mdl-33546671

RESUMEN

BACKGROUND: Obstetric genital fistulas are an uncommon condition in developed countries. We evaluated their causes and management in women treated at a German pelvic floor centre. METHODS: Women who had undergone surgery for obstetric genital fistulas between January 2006 and June 2020 were identified, and their records were reviewed retrospectively. RESULTS: Eleven out of 40 women presented with genitourinary fistulas, and 29 suffered from rectovaginal fistulas. In our cohort, genitourinary fistulas were more common in multiparous women (9/11), and rectovaginal fistulas were more common in primiparous women (24/29). The majority of the genitourinary fistulas were at a high anterior position in the vagina, and all rectovaginal fistulas were at a low posterior position. While all genitourinary fistulas were successfully closed, rectovaginal fistula closure was achieved in 88.65% of cases. Women who suffered from rectovaginal fistulas and were at high risk of recurrence or postoperative functional discomfort and desired another child, we recommended fistula repair in the context of a subsequent delivery. For the first time, pregnancy-related changes in the vaginal wall were used to optimize the success rate of fistula closure. CONCLUSIONS: In developed countries, birth itself can lead to injury-related genital fistulas. As fistula repair lacks evidence-based guidance, management must be tailored to the underlying pathology and the surgeon's experience. Attention should be directed towards preventive obstetric practice and adequate perinatal and postpartum care. Although vesicovaginal fistulas occur rarely, in case of urinary incontinence after delivery, attention should be paid to the patient, and a vesicovaginal fistula should be ruled out. Trial registration Retrospectively registered, DRKS 00022543, 28.07.2020.


Asunto(s)
Diafragma Pélvico , Fístula Vesicovaginal , Niño , Femenino , Alemania , Humanos , Embarazo , Fístula Rectovaginal/etiología , Fístula Rectovaginal/cirugía , Fístula Vesicovaginal/etiología , Fístula Vesicovaginal/cirugía
10.
J Clin Med ; 9(8)2020 Aug 03.
Artículo en Inglés | MEDLINE | ID: mdl-32756295

RESUMEN

Uterus transplantation (UTx) can provide a route to motherhood for women with Mayer-Rokitansky-Küster-Hauser syndrome (MRKHS), a congenital disorder characterized by uterovaginal aplasia, but with functional ovaries. Based on our four successful living-donor transplantations and two resulting births, this analysis presents parameters relevant to standardizing recipient/donor selection, UTx surgery, and postoperative treatment, and their implementation in routine settings. We descriptively analyzed prospectively collected observational data from our four uterus recipients, all with MRKHS, their living donors, and the two newborns born to two recipients, including 1-year postnatal follow-ups. Analysis included only living-donor/recipient pairs with completed donor/recipient surgery. Two recipients, both requiring ovarian restimulation under immunosuppression after missed pregnancy loss in one case and no pregnancy in the other, each delivered a healthy boy by cesarean section. We conclude that parameters crucial to successful transplantation, pregnancy, and childbirth include careful selection of donor/recipient pairs, donor organ quality, meticulous surgical technique, a multidisciplinary team approach, and comprehensive follow-up. Surgery duration and blood vessel selection await further optimization, as do the choice and duration of immunosuppression, which are crucial to timing the first embryo transfer. Data need to be collected in an international registry due to the low prevalence of MRKHS.

11.
BMC Urol ; 20(1): 126, 2020 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-32814553

RESUMEN

BACKGROUND: Aim of this study is to examine pelvic floor symptoms, anatomical results and patients' satisfaction after sacrospinous vaginal fixation for stage 4 pelvic organ prolapse. METHODS: All patients with stage 4 pelvic organ prolapse were treated with vaginal hysterectomy, native tissue cystocele and rectocele repair and bilateral sacrospinous vaginal fixation. Anatomical and functional outcomes according to the POPq classification system and the German version of the Australian pelvic floor questionnaire were assessed. Changes between baseline, first follow-up and second follow-up were assessed by the paired Wilcoxon rank test using R, version 3.5.1. RESULTS: 20 patients were included in the study. Scores in all four domains of the pelvic floor symptom questionnaire (bladder, bowel, prolapse, sexual function) were significantly improved at 6 and 12-months follow-up. One patient presented with a symptomatic stage 3 cystocele that needed a second surgical intervention and two patients needed surgery due to a de novo stress urinary incontinence. There were no perioperative adverse events and all patients reported full satisfaction after surgery. CONCLUSIONS: The vaginal approach with hysterectomy, native tissue repair and bilateral sacrospinous vaginal fixation seems to be a safe and effective method for the treatment of advanced stage POP, offering excellent relief in all pelvic floor symptoms. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02998216 ), December 20th, 2016. Prospectively registered.


Asunto(s)
Histerectomía , Prolapso de Órgano Pélvico/cirugía , Anciano , Femenino , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Ligamentos/cirugía , Persona de Mediana Edad , Estudios Prospectivos , Autoinforme , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
12.
Cancers (Basel) ; 12(2)2020 Jan 22.
Artículo en Inglés | MEDLINE | ID: mdl-31979067

RESUMEN

Non-invasive physical plasma (NIPP) generated by non-thermally operated electrosurgical argon plasma sources is a promising treatment for local chronic inflammatory, precancerous and cancerous diseases. NIPP-enabling plasma sources are highly available and medically approved. The purpose of this study is the investigation of the effects of non-thermal NIPP on cancer cell proliferation, viability and apoptosis and the identification of the underlying biochemical and molecular modes of action. For this, cervical cancer (CC) single cells and healthy human cervical tissue were analyzed by cell counting, caspase activity assays, microscopic and flow-cytometric viability measurements and molecular tissue characterization using Raman imaging. NIPP treatment caused an immediate and persisting decrease in CC cell growth and cell viability associated with significant plasma-dependent effects on lipid structures. These effects could also be identified in primary cells from healthy cervical tissue and could be traced into the basal cell layer of superficially NIPP-treated cervical mucosa. This study shows that NIPP treatment with non-thermally operated electrosurgical argon plasma devices is a promising method for the treatment of human mucosa, inducing specific molecular changes in cells.

13.
ACS Appl Mater Interfaces ; 11(46): 42885-42895, 2019 Nov 20.
Artículo en Inglés | MEDLINE | ID: mdl-31657892

RESUMEN

Noninvasive epithelial tissue treatment with cold atmospheric plasma (CAP) is a promising option for local treatment of chronic inflammatory and precancerous lesions as well as various mucosal cancer diseases. Atmospheric pressure plasma jets (APPJ) are well-characterized and medically approved plasma sources. There are numbers of medically approved plasma sources for the treatment of epithelial diseases; however, little is known about the biochemical effects of CAP at the plasma-tissue interface. Furthermore, the actual penetration depth of CAP into tissue is currently unclear. Noninvasive and marker-independent Raman microspectroscopy was employed to assess the molecular effects of CAP on single cells and primary human cervical tissue samples. CAP treatment showed immediate and persisting changes of specific molecular tissue components determined by multivariate analysis. Raman imaging identified CAP-dependent changes in the morphology of the tissue, as well as molecular tissue components. The expression of the different components was not significantly altered within 24 h of incubation. DNA and lipids showed the strongest changes upon CAP treatment, which were traced to the basal cell layer of cervical epithelium, corresponding to an average functional plasma penetration depth of roughly 270 µm. In this study, Raman microspectroscopy is shown to be a promising method for molecular single-cell and solid tissue characterization. Regarding CAP treatment of tissues, Raman microspectroscopy could be suitable for the screening of biological mechanisms as well as for future contact- and marker-independent monitoring of plasma tissue effects.


Asunto(s)
Biomarcadores de Tumor/metabolismo , Cuello del Útero , Proteínas de Neoplasias/metabolismo , Gases em Plasma/farmacología , Lesiones Precancerosas , Neoplasias del Cuello Uterino , Línea Celular Tumoral , Cuello del Útero/metabolismo , Cuello del Útero/patología , Femenino , Humanos , Membrana Mucosa/metabolismo , Membrana Mucosa/patología , Lesiones Precancerosas/tratamiento farmacológico , Lesiones Precancerosas/metabolismo , Lesiones Precancerosas/patología , Neoplasias del Cuello Uterino/tratamiento farmacológico , Neoplasias del Cuello Uterino/metabolismo , Neoplasias del Cuello Uterino/patología
14.
Zentralbl Chir ; 144(4): 380-386, 2019 Aug.
Artículo en Alemán | MEDLINE | ID: mdl-31291666

RESUMEN

Obstetric injuries can rarely lead to formation of rectovaginal fistula (RVF). The aim of this retrospective study was to evaluate the causes and management of obstetric rectovaginal fistulas in patients treated at the Department of Obstetrics and Gynecology, Tuebingen, from January 2015 to April 2019. Five of 12 surgically treated rectovaginal fistulas were primary fistulas, and 7 patients had recurrence of a fistula. The surgery was carried out by using a vaginal approach following birth or in the context of a subsequent delivery. The latter procedure was chosen in patients at high risk of recurrence or in those who had a high risk of postoperative functional discomfort. For the first time, pregnancy-related changes of the vaginal wall were used to optimise the success rates of a fistula closure. 11 of 12 obstetric rectovaginal fistulas could be closed successfully. The choice of rectovaginal fistula repair should be tailored to the underlying pathology, the type of repair performed previously, the patient's wishes and the surgeon's experience. The therapy of rectovaginal fistulas in special centres is clearly beneficial.


Asunto(s)
Fístula Rectovaginal , Femenino , Ginecología , Humanos , Embarazo , Estudios Retrospectivos , Colgajos Quirúrgicos , Resultado del Tratamiento
15.
Zentralbl Chir ; 144(4): 374-379, 2019 Aug.
Artículo en Alemán | MEDLINE | ID: mdl-31174226

RESUMEN

BACKGROUND: Despite a variety of surgical procedures for rectovaginal fistulas, surgical therapy remains a considerable challenge. Therefore, it was the aim of this prospective study to evaluate preliminary results of an innovative technique. METHODS: Surgical transperineal ligation of the fistula tract was performed without any fistulectomy or sphincter reconstruction. Only lower rectovaginal fistulas were selected for this technique. Standardised inclusion and exclusion criteria were defined. RESULTS: Within a 16-month period, 7 female patients with lower rectovaginal fistulas were treated by transperineal ligation of the fistula tract in two centres. Rectovaginal fistulas were associated with iatrogenic obstetric trauma, following Bartholin infection, and with Crohn's disease. In all cases, rectovaginal fistulas could be identified and treated by ligation of the fistula tract. Neither intra- nor postoperative complications were documented. Only one operation was performed under fecal diversion. After a mean follow-up of 9 months, fistula healing was observed in 4 of 7 patients (success rate 57%). CONCLUSION: Preliminary results of transperineal ligation of the fistula tract for rectovaginal fistulas seem to be promising. However, further experience, larger series and long-term follow-up have to be provided to objectively assess this innovative technique.


Asunto(s)
Enfermedad de Crohn , Fístula Rectovaginal , Femenino , Humanos , Inflamación , Complicaciones Posoperatorias , Embarazo , Estudios Prospectivos , Resultado del Tratamiento
16.
Arch Gynecol Obstet ; 299(4): 1015-1022, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30805706

RESUMEN

PURPOSE: Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact® vs. RetroArc®) inserted in two different ways regarding perioperative and mid-term outcomes. METHODS: In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure. RESULTS: Of the 303 women, 152 were randomized to the TVT® and 151 to the RetroArc® operation. At 3 months, n = 288 (95.0%) and at 12 months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc®-procedure was not inferior to TVT® (p = 0.144). In subjective cure, however, the TVT exact® procedure achieved significant better results (TVT® 76.1%, RetroArc® 54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact®-procedure. CONCLUSIONS: Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.


Asunto(s)
Cabestrillo Suburetral/normas , Incontinencia Urinaria de Esfuerzo/cirugía , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento
17.
Geburtshilfe Frauenheilkd ; 78(10): 991-998, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-30364366

RESUMEN

Introduction The complication of tape erosion in the urethra following placement of a retropubic (TVT) or transobturator (TOT) tension-free suburethral vaginal sling or an accidental iatrogenic transurethral tape position can result in the formation of a urethrovaginal or vesicovaginal fistula. The objective of the investigation is the evaluation of the management of such rare complications. Patients and Methods Retrospective analysis of 14 patients who were treated for a urethral lesion or urethrovaginal fistula formation status post TVT/TOT placement between June 2011 and February 2018 in the Tübingen University Department of Gynaecology. Results As surgical therapy, 57.1% (n = 8) cases underwent vaginal fistula closure using a Martius flap of the labium majus and in 21.4% (n = 3) using a vaginal rotation skin flap. In 21.4% (n = 3), exclusively vaginal suture reconstruction of the urethra following excision of the tape running transurethrally or tape erosion was performed. 50% (n = 7) of the patients had lasting continence postoperatively without any further need for therapy. In 28.6% (n = 4), there was ongoing stress urinary incontinence, in 21.4% (n = 3) mixed urinary incontinence. Six of the 7 patients with persistent incontinence underwent new placement of a tension-free suburethral retropubic sling (TVT) an average of 8.8 months (5 - 13 months) postoperatively which was uncomplicated in all patients and achieved satisfactory continence. The 3 patients with mixed urinary incontinence and persistent urgency components additionally received anticholinergic medication. During the time period investigated, there were no long-term complications, in particular no recurrent fistulas. Conclusion The rare but relevant complications of a urethral erosion, transurethral tape position or urethrovaginal fistula formation status post TVT/TOT placement can be successfully managed via vaginal surgery. Persistent postoperative urinary incontinence with the need for a two-phase repeat TVT placement following sufficient wound healing must be preoperatively clarified.

18.
Arch Gynecol Obstet ; 298(2): 353-361, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29931524

RESUMEN

OBJECTIVE: To report the perioperative adverse events associated with nerve-preserving sacropexy for pelvic organ prolapse (POP) repair and to identify risk factors that could predict possible adverse events. MATERIALS AND METHODS: A total of 768 women who underwent sacropexy for POP repair performed by one surgeon using the same technique, beyond the learning curve, over a 10-year period, between January 1st 2007 and December 31st 2016. METHODS: The medical records of 768 women were reviewed for age, body mass index (BMI), tobacco use, previous surgeries (for POP and incontinence, abdominal surgeries in general), operating time, duration of hospitalization and perioperative events at time of surgery and 6 weeks postoperatively. Additionally, the complications were classified according to the Clavien-Dindo grading system and the Charlson Age Comorbidity Index (CACI) was evaluated for the patients. RESULTS: Between January 1st 2007 and December 31st 2016, 768 patients underwent sacropexy for POP. 27 (3.5%) adverse events occurred intra- and post-operative within 6 weeks after surgery. In univariate and multivariate analyses, only comorbidity and concomitant posterior colporrhaphy are significantly associated with complications. CONCLUSIONS: Surgeon's experience and a standardized technique minimize the risk of perioperative adverse events. The data on complications we found can be used to guide effective consent.


Asunto(s)
Complicaciones Intraoperatorias/epidemiología , Prolapso de Órgano Pélvico/cirugía , Anciano , Comorbilidad , Femenino , Humanos , Complicaciones Intraoperatorias/prevención & control , Persona de Mediana Edad , Tempo Operativo , Estudios Retrospectivos , Factores de Riesgo
19.
Acta Obstet Gynecol Scand ; 97(7): 830-837, 2018 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-29603118

RESUMEN

INTRODUCTION: It is unclear how pelvic floor supporting structures might be affected by the absence of the vagina. It was the aim of this prospective study to analyze the magnetic resonance imaging morphology of pelvic support prior and after a Vecchietti procedure in women suffering Mullerian agenesis (Mayer-Rokitansky-Küster-Hauser syndrome). MATERIAL AND METHODS: 26 women with a diagnosis of Mayer-Rokitansky-Küster-Hauser syndrome associated vaginal agenesis were recruited prospectively prior to the laparoscopic creation of a neovagina according to the Vecchietti procedure. The primary outcome measure was the magnetic resonance imaging morphology of supporting structures. Secondary outcome measures were anatomical and functional vaginal length. Follow up was conducted six months after surgery. RESULTS: Twenty-six women were analyzed. Mean age was 19.8 ± 4.4 years (±SD) and mean body mass index was 23.7 ± 4.3 kg/m2 (±SD). All were Caucasian. Supporting structures consistent with cardinal and uterosacral ligaments were visible on magnetic resonance imaging in all cases (100%). There were no levator ani defects. The vaginal apex could be visualized postoperatively in 12 women (46.2%) reaching up to Level I. The vagina was visible in both Level II and III with normal relations to the pelvic walls in all cases. On gynecological examination, vaginal length was 8.8 ± 2.1 cm (mean ± SD) anatomically and 10.2 ± 2.2 cm (mean ± SD) functionally. CONCLUSIONS: The preoperative presence of pelvic support structures into which the vagina is lengthened by the surgery likely explains the uncommon occurrence of vaginal prolapse in women who had the Vecchietti procedure.


Asunto(s)
Trastornos del Desarrollo Sexual 46, XX/cirugía , Anomalías Congénitas/cirugía , Imagen por Resonancia Magnética , Conductos Paramesonéfricos/anomalías , Estructuras Creadas Quirúrgicamente , Vagina/diagnóstico por imagen , Femenino , Humanos , Laparoscopía , Conductos Paramesonéfricos/cirugía , Estudios Prospectivos , Resultado del Tratamiento , Vagina/anomalías , Vagina/cirugía , Adulto Joven
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