Complications and objective outcomes of uterine preserving surgeries for the repair of pelvic organ prolapse versus procedures removing the Uterus, a systematic review.

BACKGROUND: Several authors have recently compared the outcomes and complications of surgical procedures that preserve or remove the uterus in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Following the publication of several high quality randomized control trials on this topic we performed a new systematic review and meta analysis of this data. METHODS: We performed a systematic literature search in ClinicalTrials.gov, PubMed, Scopus, Ovid, EBSCO host, Science Direct, Web of Science, and Cochrane CENTRAL for randomized controlled and cohort trials of uterine sparing prolapse repair (hysteropexy) versus hysterectomy with suspension. A total of 1285 patients from 14 studies were included in our systematic review and meta-analysis. RESULTS: Uterine sparing procedures (hysteropexy) were comparable to hysterectomy with suspension for recurrence rates (RR = 0.908, 95% CI [0.385, 2.143]), reoperation rates (RR = 1.517, 95% CI [0.802, 2.868]), length of hospital stay, (SMD =  - 0.159 days, 95% CI [-0.375, 0.057]), voiding dysfunction (RR = 1.089, 95% CI [0.695, 1.706]), and intraoperative blood loss (SMD =  - 0.339, 95% CI [-0.631, 0.047]). However, hysteropexy had shorter operative time than hysterectomy with suspension (SMD =  - 1.191 h, 95% CI [-1.836, -0.545]), and fewer visceral injuries (RR = 0.421, 95% CI [0.244, 0.725]). CONCLUSION: We found no significant differences in the outcomes or major complications of uterine preserving surgical procedures versus those which include hysterectomy in the treatment of POP. Hysteropexy procedures may be associated with a shorter operative time and fewer visceral injuries. This is consistent with older analyses.

Feasibility of Risk Reducing Salpingo-Oophorectomy at the Time of Abdominal Surgery for Correction of Pelvic Organ Prolapse and Urinary Incontinence.

OBJECTIVE: The objective of this study is to assess the perioperative outcomes when prophylactic bilateral salpingo-oophorectomy (BSO) is performed concomitantly with surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI). MATERIALS AND METHODS: This is a retrospective case-control study of patients who underwent abdominal surgery for the correction of POP and/or SUI with or without concomitant BSO at a tertiary care center. The primary outcome measures were postsurgery length of hospitalization, estimated blood loss, and 30-day readmission rate. The secondary outcome measure was detection of ovarian cancer precursor lesions. RESULTS: We identified 734 patients who had surgery for POP and/or SUI. The control group contained 385 patients, and the BSO group contained 349 patients. There was no difference between the control and BSO groups in the postsurgery length of stay (LOS) (35.2 h vs. 34.1 h; P = 0.49), and all-cause 30-day readmission rate (14.2% vs. 11.6%; P = 0.3085). However, there was decreased blood loss (40.8 ml vs. 67.2 ml, P < 0.0001) in the BSO group compared to the control group. Sub-analysis of primary outcomes in postmenopausal women (age > 55) showed decreased postsurgery LOS (33.4 h vs. 37.4 h; P = 0.0208) and decreased blood loss (35.9 ml vs. 82.7 ml; P < 0.0001) in the BSO group compared to control. CONCLUSION: Secondary to the lack of additional complications, we recommend surgeons give more consideration to finding appropriate candidates for a risk reducing BSO at time of abdominal surgery to repair POP or SUI.

Comparison of Mechanical Characteristics of Commonly Used Vaginal Packing Materials.

INTRODUCTION: Clinically, vaginal packing provides the benefit of hemostasis and is designed to prevent the formation of postoperative hematomas. Despite the common use of vaginal packing in pelvic surgery, there is limited data to indicate which material has the ideal characteristics for vaginal packing. MATERIALS AND METHODS: Three packing materials were used: DeRoyal® Fluftex™ (DeRoyal Industries, Inc., Powell, Tennessee), NHP Surgi-Pak™ vaginal packing (NHP Industries, Inc., City of Industry, California), and Curad® Plain Packing Strips (Medline Industries, Inc., Northfield, Illinois). A fluid with similar viscosity to human blood, defibrinated sheep's blood (Remel Laboratories, Nenexa Kansas) was used to saturate the materials. The primary outcome was the amount of fluid absorbance of each product in both the handpacked and unpacked state. The number of drops used to saturate each material were counted and converted to mL/g. Each product was tested three times and the results were measured by counting the number of drops needed to saturate the material in each experiment. Experiment: Three materials were obtained and conducted into two different experiments to test absorbance. The packed trial consisted of 0.1g of material and was compacted in a 146mm standard Pasteur pipette (Sigma-Aldrich Corp., St. Louis, Missouri). Droplets of sheep's blood were dispensed until each material had reached its capacity, which was determined by counting the last sequential drop received onto the respective material before the first of the fluid fell from the material into the collecting container. Trials were conducted three times per material and an average of the three trials was calculated. The second experiment tested 1g of each material unpacked and folded into eight layers. Droplets of blood were placed onto the material until each material leaked, which was defined again as the first fluid to fall from the material into the collecting container that it was suspended above. The number of drops needed to produce this effect was recorded. All droplets were counted and converted to mL/g. Standard deviation was calculated for each material in both experiments and an analysis of variance (ANOVA) single factor test was done. RESULTS: Three trials were conducted per material and there was a difference in absorbance between each packing material (p=0.02 packed, p=0.001 unpacked). Additionally, the plain packing strip absorbed the least amount of blood product in the packed and unpacked state compared to DeRoyal® Fluftex™ and NHP Surgi-Pak™ vaginal packing. The average absorbance of the packed materials was 7.7mL/g for DeRoyal® Fluftex™, 9.8mL/g for NHP Surgi-Pak™ vaginal packing, and 7.5mL/g for the Curad® Plain Packing Strips. There was a standard deviation of 2.08 drops for DeRoyal® Fluftex™, 3.51 drops for NHP Surgi-Pak™ vaginal packing, and 1.73 drops for Curad® Plain Packing Strips. Absorbance for DeRoyal® Fluftex™ unpacked was 8.2mL/g, NHP Surgi-Pak™ vaginal packing unpacked was 7.00mL/g, and Curad® Plain Packing Strips was 4.8mL/g. The standard deviation for the unpacked experiment was 29.02 drops for DeRoyal® Fluftex™, 13.61 drops for NHP Surgi-Pak™ vaginal packing, and 15.59 drops for Curad® Plain Packing Strips. A p-value of less than .05 in a confidence interval of 95% was determined. CONCLUSION: Even though there are studies showing the clinical benefits of vaginal packing after a variety of gynecological surgeries, there is less known about the characteristics of the ideal material. Minimal foreign body reaction, decreased adherence to surgical scars, X-ray visualization, low cost, and easy availability are among the ideal characteristics of the presumed ideal material used for vaginal packing. In this study, we compared the absorbance between three commonly used materials and did not find any statistical differences. Further studies are needed to show the clinical benefits and mechanical characteristics of material used for vaginal packing. Due to the lack of a statistically significant difference in absorbance between the materials, evaluation of mechanical characteristics may be beneficial in determining an ideal vaginal packing product.

Urinary incontinence and quality of life in endometrial cancer patients after robotic-assisted laparoscopic hysterectomy with lymph node dissection.

To determine the long-term effects of lymph node dissection on lower urinary tract symptoms in patients treated for endometrial cancer. We conducted a retrospective cohort study of 74 patients with International Federation of Gynaecology and Obstetrics (FIGO) Stage I endometrial cancer who underwent surgical intervention with and without lymph node dissection, and evaluated them with the Urinary Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7). Patients who underwent lymph node dissection reported higher but not statistically different rates of bother by lower urinary tract symptoms compared to those without lymph node dissection. The scores for the lymph node dissection group and the control group were a mean IIQ-7 score of 14.9 ± 23 and 10.5 ± 22.9 (p=.419) and a mean UDI-6 score of 30.0 ± 25.3 and 20.7 ± 22.9 (p=.104), respectively. Lymph node dissection at the time of robotic-assisted surgery did not have a significant effect on lower urinary tract symptoms nor did it affect patient responses on quality of life questionnaires. IMPACT STATEMENT What is already known on this subject? The aetiology of urinary incontinence is multifactorial and there has been debate on how a patient's surgical history affects their risk of developing urinary incontinence. Prior studies have highlighted the relationship between hysterectomy and urinary incontinence (Milsom et al. 1993 ). Additional research has also been done to elucidate the prevalence of pelvic floor disorders in patients who have been surgically treated for endometrial cancer (Erekson et al. 2009 ; Nosti et al. 2012 ). There is limited information on how robotic-assisted lymphadenectomy during surgical staging for endometrial cancer affects patients' urinary function and their quality of life. What do the results of this study add? In this manuscript, we demonstrate that patients who underwent robotic-assisted total laparoscopic hysterectomy (TLH) with lymphadenectomy neither had significant difference in lower urinary tract symptoms nor on quality of life questionnaires as compared to those who did not undergo lymphadenectomy. Worsening of quality of life in regards to urinary incontinence should not be considered a factor of long term surgical morbidity associated with lymph node dissection. What are the implications of these findings for clinical practice and/or further research? There is a need for further studies that focus on the prevalence of pelvic floor disorders in patients after undergoing surgical staging for endometrial cancer and potential interventions that may address these issues.

Tumor-Like Reaction to Polypropylene Mesh from a Mid-Urethral Sling Material Resembling Giant Cell Tumor of Vagina.

BACKGROUND: Polypropylene material is widely used in gynecological surgery. There are few reports regarding its carcinogenic potential. There is lack of evidence supporting tumor formation directly attributed to the use of polypropylene material. CASE: This patient is a 49-year-old woman with a history of stress urinary incontinence which required a MiniArc® Sling who presented with a hard, tender, immobile mass on the anterior vaginal wall. Pathological analysis of the mass revealed a tumor-like reaction to the polypropylene material that resembled a giant cell tumor of soft tissue. CONCLUSION: The use of polypropylene in surgery is ubiquitous across disciplines; thus consideration for a tumor-like reaction to the material should exist for patients who present with a mass near the surgical site.

Polypropylene Mesh Sling for Stress Urinary Incontinence: Does Memory Shaping of the Polypropylene Mesh Matter?

We report a case of a mid-urethral sling (Advantage Fit™, Boston Scientific Corporation, Marlborough, Massachusetts) freshly removed from its original package. Upon removal from the packaging, the sling was noted to have a deformation in positioning at the midpoint, with curvature opposite the natural curve of the sling in the body. The images show the comparison to a sling with the desired positioning. Mid-urethral slings are commonly made from polypropylene mesh which has memory properties. It is important that manufacturers ensure that any steps in the processing or packaging of slings do not result in changes in the shape of the sling that may have unknown impacts on its clinical outcome.

Correlation of Computed Tomography Measured Presacral Thickness with Body Mass Index.

Sacral colpopexy is often chosen as a reliable approach that effectively resolves vaginal vault prolapse. Advancements in minimally invasive technology, robotic and laparoscopic surgery, have helped facilitate surgical dissection and operation when performing this procedure. An increased presacral thickness can potentially present a surgical challenge when operating in the presacral space. We hypothesize that there is a correlation between body mass index and presacral thickness. Computed Tomography (CT) images of 241 patients were reviewed in this retrospective study. The presacral thickness was measured by taking the cross sectional distance from the sacral promontory to the upper aspect of the iliac arteries. The corresponding demographic information of age, body mass index (BMI), and comorbidities were evaluated using univariate analysis, linear regression, and multiple regression analysis. The mean age was 56.6 years, and BMI was 27.6. The mean presacral thickness measurement based on the CT scan was 21.08 mm. Univariate linear regression models demonstrated a positive correlation between presacral thickness and BMI and a negative correlation with age. When adjusting for both age and BMI on multivariate analysis, a positive correlation with hypertension was found. The surgeon should be aware of this potential change in anatomy when operating in the presacral space.

Morphologic Evaluation of Post-implanted Monofilament Polypropylene Mesh Utilizing a Novel Technique with Scanning Electron Microscopy Quantification.

Polypropylene mesh has been shown to shrink up to 50%; however, little is known about other changes that may occur while it is implanted. It is unclear whether such changes have clinical impact; nonetheless, knowledge of such can ultimately affect the technique of implantation and may affect outcomes. The objective of this study was to evaluate surgically explanted mesh after two years implantation for evidence of change in morphology using scanning electron microscopy (SEM). Secondly, we describe a novel technique for quantifying such changes with intentions for future validation. SEM imaging was conducted and mesh changes were visualized. SEM images revealed deep surface cracks both transverse and longitudinal, flaking and peeling of fibers, as well as fibrosis. Microstructural quantification of cracks was also completed. The fraction of transverse cracked area to whole surface area was 24.2%. Average crack length range was 0.58 to 71.46 µm and average crack thickness range was 0.99 to 25.46 µm. Polypropylene mesh is subject to structural changes after surgical implantation. It is important to investigate how these processes impact clinical outcomes. Validated techniques of quantifying such changes can prove useful in future research and aid in development of the ideal graft.

Correlation of patient age with CT-measured aorta-sacral promontory distance.

INTRODUCTION AND HYPOTHESIS: Pelvic floor disorders are becoming more prevalent in the elderly population. Since more patients are seeking definitive management for their prolapse, the number of elderly patients undergoing sacral colpopexies will likely increase. During sacral colpopexies, the surgeon must carefully dissect in the presacral space and avoid vital structures. In elderly patients the aorta potentially elongates and the vertebral body height decreases. Consequently, there is a potential for anatomical change of distance from the bifurcation of the aorta to the sacral promontory. This study aimed to correlate the aorta-sacral promontory distance with age. METHODS: From 1 January 2013 to 31 January 2014 computed tomography (CT) images of 241 patients were reviewed in this retrospective study. Radiologists measured the aorta-sacral promontory distance on sagittal acquisition. The corresponding demographic information of age, body mass index, and comorbidities was evaluated using univariate analysis and univariate linear regression. RESULTS: The mean age was 56.6 years, and BMI was 27.6. The mean aorta-sacral promontory measurement based on the CT scan was 63.11 mm. Univariate analysis using a t test and ANOVA demonstrated an inverse correlation with age (p < 0.0001) and hypertension (p = 0.0034) and a positive correlation with BMI categories (p < 0.0017) Under univariate linear regression, the weight of the patient in kilograms demonstrated positive correlation (p = 0.0413). CONCLUSIONS: Based on CT measurements, the aorta-sacral promontory distance is decreased in elderly and hypertensive patients. Heavier patients have an increased aorta-sacral promontory distance. These potential anatomical variants should be considered before operating in the presacral space.

Surface and boney landmarks for sacral neuromodulation: a cadaveric study.

INTRODUCTION AND HYPOTHESIS: Standard external landmarks have been suggested as a guide for in-office percutaneous nerve evaluation (PNE), but validity of these landmarks has not been assessed. Our objective was to determine whether the standard 9 cm from the tip of the coccyx indicates the position of the S3 sacral foramen and whether other boney landmarks and measurements improved positioning. METHODS: Measurements and distances between external boney landmarks were obtained in 22 embalmed cadavers. Spinal needles were placed 9 cm superior to the coccyx and 2 cm lateral to midline bilaterally. After dissection, internal measurements relating to sacral length, position of S3, and location of the needle in relation to S3 were recorded. Correlations among measured variables were assessed using descriptive statistics. RESULTS: Mean distance from the tip of coccyx to S3 was 9.26 cm (±0.84), from S3 to midline 2.30 cm (±0.2); from needle to S3 1.25 cm, and needle placement was as likely to be placed above or below S3; and S2-S3 and S3-S4 interforamenal distance 1.48 cm (±0.30) and 1.48 cm (±0.24), respectively. Mean distance from S3 to sacroiliac joint (SIJ) was shorter than S2 to SIJ. All associations between external measurements and length from tip of coccyx to S3 were not significant. CONCLUSION: A distance 9 cm from the tip of the coccyx is a reasonable starting landmark for in-office blind PNE. However, given the variability in coccyx length, caution should be taken; also, sensory-motor response is necessary to confirm proper placement.

Robotic Burch colposuspension: a surgical case and instructional video.

INTRODUCTION AND HYPOTHESIS: The Burch colposuspension is a well-studied and proven surgical treatment for stress urinary incontinence without intrinsic sphincter deficiency. The advent of the minimally invasive mid-urethral sling has given rise to diminished surgical experience in performing the Burch. Recent anti-mesh media and FDA notifications have caused patients to demand mesh-free surgery, resulting in an opportunity for the resurgence of the Burch procedure. The objective of this video is to demonstrate surgical technique and instruction for a robotic Burch colposuspension as well as recommendations for successful completion of the procedure. Additionally, the video reviews and illustrates pertinent surgical anatomy regardless of approach. METHODS: The patient is a 53-year-old woman who presented with symptoms of vaginal pressure, urinary incontinence, and constipation. She had symptoms and urodynamics consistent with mixed urinary incontinence without intrinsic sphincter deficiency and had been treated with antimuscarinics for overactive bladder. On examination she was found to have stage II prolapse. She desired surgical management of both her prolapse and stress incontinence. CONCLUSION: Robotic Burch colposuspension can be completed in a safe and effective manner and should be considered as an option for patients in whom an anti-incontinence procedure is indicated and who are already undergoing robotic surgery.

The anatomical outcome of robotic sacrocolpopexy for treatment of pelvic organ prolapse: a comparison of obese and non-obese patients.

The purpose of this study is to compare the anatomical outcome of robotic sacrocolpopexy for pelvic organ prolapse in women with a body mass index (BMI) of 30 and higher to those with a BMI under 30. This is a retrospective chart review. POP-Q measurements preoperatively and 12 months postoperatively were evaluated using non-parametric statistical analysis. The primary outcome was to compare postoperative POPQ measurements at 12 months following surgery. Secondary outcomes were age at the time of surgery, mesh erosion rate, blood loss, length of hospital stay, and baseline anatomical support. A total of 71 patients were identified: 44 patients had a BMI below 30, and 27 had a BMI equal to or greater than 30. We found no significant relationship between BMI and anatomical support at 12 months post operation. However, obese patients were younger at the time of prolapse surgery (53.6 versus 60.6 years of age, p=0.0022). In regards to the ICS prolapse stage, no difference was found between obese and non-obese patients (2.81 versus 2.95, p=0.17).

To mesh or not to mesh with polypropylene: does carcinogenesis in animals matter?

Polypropylene in sheets has been been found to be carcinogenic in some laboratory animals. Although no human carcinogenicity has been reported, long-term follow-up in humans implanted with polypropylene mesh will be important.

Evaluation of surgical instrument handling on polypropylene mesh using scanning electron microscopy.

INTRODUCTION AND HYPOTHESIS: To evaluate the effect of surgical instruments handling on polypropylene mesh using scanning electron microscopy (SEM). METHODS: We applied different surgical instruments, including a few robotic ones, to pieces of polypropylene mesh. SEM was used to evaluate the morphological changes with this intervention. RESULTS: Straight hemostat, laparoscopic atraumatic grasper, laparoscopic needle driver, and robotic instruments (Bipolar forceps, Cadiere forceps, PK dissecting forceps and SutureCut) were applied to the mesh. SEM images of tool-affected mesh regions in specimens handled by different instruments along with the images of intact mesh were obtained. Average mesh fiber diameters, as well as the average parameters characterizing instrument-affected regions, were measured. There was substantial widening of the fibers in specimens handled by hemostat or a needle holder. An elliptical but much longer and narrower tool marking with more surface roughness was observed in mesh handled by a grasper. A ∼25-µm-wide and ∼200-µm-long strap was split on one side from the core of the fiber caused by Cadiere. CONCLUSIONS: There are morphological changes to polypropylene mesh caused by instrument handling. These changes are different depending on the instrument used. These alterations vary from changes in the surface creating roughness of the fiber, compression of the mesh with narrowing of the fiber in at least one direction or actual splitting or pitting of the fiber. Since there are no data regarding the effect of these morphological changes to the ultimate functioning of the mesh, surgeons should minimize mesh handling by instruments.

Post-implantation alterations of polypropylene in the human.

PURPOSE: We reviewed the mechanisms by which polypropylene mesh changes after implantation in the human body. MATERIALS AND METHODS: The existing polymer and medical literature was reviewed regarding polypropylene, including its chemical characteristics, and compositional and physical properties, which undergo alteration after implantation at various human body locations. We also reviewed the changes in those physical properties that were demonstrable in explanted specimens. RESULTS: Polypropylene in mesh form is commonly considered inert and without adverse reactions after implantation in humans. The literature suggests otherwise with reports of various degrees of degradation, including depolymerization, cross-linking, oxidative degradation by free radicals, additive leaching, hydrolysis, stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis. Many substances added to polypropylene for various purposes during manufacture behave as toxic substances that are released during the degradation process. The material may also absorb various substances. These alterations in the chemical structure of polypropylene are responsible for visibly demonstrable fiber changes, resulting in the loss of structural integrity through material embrittlement. The heat of manufacturing polypropylene fibers begins the degradation process, which is augmented by the post-production heat used to flatten the mesh to prevent curling and attach anchoring appendages. CONCLUSION: Based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body. The quest for the perfect mesh must continue.

Polypropylene mesh and the host response.

The use of polypropylene (PP) mesh for pelvic floor repair has been increasing dramatically over the past decade; however, tissue response in humans has not been extensively studied. This review discusses PP mesh and postimplantation host tissue response. Emphasis is placed on studies investigating the relationship between individual mesh properties and specific responses. There is an immediate inflammatory response after PP mesh implantation that lays the framework for tissue ingrowth and subsequent mesh integration. This response varies based on physical properties of individual mesh, such as pore size, weight, coatings, bacterial colonization, and biofilm production.

Evidence-based medicine for polypropylene mesh use compared with native tissue vaginal prolapse repair.

A review of the current medical literature for the use of polypropylene (PP) mesh for vaginally performed prolapse repair, including only those studies reporting prospective, randomized, controlled trials compared with native tissue repairs was undertaken. Five full manuscript publications and 4 studies still in abstract form were all consistent with PP mesh producing better anatomical results for cystocele repair, but when functional results in terms of the patient's quality of life are considered, no significant difference is found between PP mesh and native tissue repairs. PP mesh use results in better anatomical results in the short term but at a cost of repeated surgeries because of erosions and other complications. Patients do not recognize any added benefit from the use of these prostheses in their daily lives.

Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known.

Many properties of polypropylene mesh that are causative in producing the complications that our patients are experiencing were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. These factors were not sufficiently taken into account prior to the sale of these products for use in patients. This report indicates when this information was available to both mesh kit manufacturers and the Food and Drug Administration.