Risk of thrombosis and bleeding in gynecologic noncancer surgery: systematic review and meta-analysis.

OBJECTIVE: This study aimed to provide procedure-specific estimates of the risk for symptomatic venous thromboembolism and major bleeding in noncancer gynecologic surgeries. DATA SOURCES: We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar. Furthermore, we performed separate searches for randomized trials that addressed the effects of thromboprophylaxis. STUDY ELIGIBILITY CRITERIA: Eligible studies were observational studies that enrolled ≥50 adult patients who underwent noncancer gynecologic surgery procedures and that reported the absolute incidence of at least 1 of the following: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding that required reintervention (including re-exploration and angioembolization), bleeding that led to transfusion, or postoperative hemoglobin level <70 g/L. METHODS: A teams of 2 reviewers independently assessed eligibility, performed data extraction, and evaluated the risk of bias of the eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine the cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors and used the Grading of Recommendations Assessment, Development and Evaluation approach to rate the evidence certainty. RESULTS: We included 131 studies (1,741,519 patients) that reported venous thromboembolism risk estimates for 50 gynecologic noncancer procedures and bleeding requiring reintervention estimates for 35 procedures. The evidence certainty was generally moderate or low for venous thromboembolism and low or very low for bleeding requiring reintervention. The risk for symptomatic venous thromboembolism varied from a median of <0.1% for several procedures (eg, transvaginal oocyte retrieval) to 1.5% for others (eg, minimally invasive sacrocolpopexy with hysterectomy, 1.2%-4.6% across patient venous thromboembolism risk groups). Venous thromboembolism risk was <0.5% for 30 (60%) of the procedures; 0.5% to 1.0% for 10 (20%) procedures; and >1.0% for 10 (20%) procedures. The risk for bleeding the require reintervention varied from <0.1% (transvaginal oocyte retrieval) to 4.0% (open myomectomy). The bleeding requiring reintervention risk was <0.5% in 17 (49%) procedures, 0.5% to 1.0% for 12 (34%) procedures, and >1.0% in 6 (17%) procedures. CONCLUSION: The risk for venous thromboembolism in gynecologic noncancer surgery varied between procedures and patients. Venous thromboembolism risks exceeded the bleeding risks only among selected patients and procedures. Although most of the evidence is of low certainty, the results nevertheless provide a compelling rationale for restricting pharmacologic thromboprophylaxis to a minority of patients who undergo gynecologic noncancer procedures.

Risk of thrombosis and bleeding in gynecologic cancer surgery: systematic review and meta-analysis.

OBJECTIVE: This study aimed to provide procedure-specific estimates of the risk of symptomatic venous thromboembolism and major bleeding in the absence of thromboprophylaxis, following gynecologic cancer surgery. DATA SOURCES: We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar for observational studies. We also reviewed reference lists of eligible studies and review articles. We performed separate searches for randomized trials addressing effects of thromboprophylaxis and conducted a web-based survey on thromboprophylaxis practice. STUDY ELIGIBILITY CRITERIA: Observational studies enrolling ≥50 adult patients undergoing gynecologic cancer surgery procedures reporting absolute incidence for at least 1 of the following were included: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding requiring reintervention (including reexploration and angioembolization), bleeding leading to transfusion, or postoperative hemoglobin <70 g/L. METHODS: Two reviewers independently assessed eligibility, performed data extraction, and evaluated risk of bias of eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors. The GRADE approach was applied to rate evidence certainty. RESULTS: We included 188 studies (398,167 patients) reporting on 37 gynecologic cancer surgery procedures. The evidence certainty was generally low to very low. Median symptomatic venous thromboembolism risk (in the absence of prophylaxis) was <1% in 13 of 37 (35%) procedures, 1% to 2% in 11 of 37 (30%), and >2.0% in 13 of 37 (35%). The risks of venous thromboembolism varied from 0.1% in low venous thromboembolism risk patients undergoing cervical conization to 33.5% in high venous thromboembolism risk patients undergoing pelvic exenteration. Estimates of bleeding requiring reintervention varied from <0.1% to 1.3%. Median risks of bleeding requiring reintervention were <1% in 22 of 29 (76%) and 1% to 2% in 7 of 29 (24%) procedures. CONCLUSION: Venous thromboembolism reduction with thromboprophylaxis likely outweighs the increase in bleeding requiring reintervention in many gynecologic cancer procedures (eg, open surgery for ovarian cancer and pelvic exenteration). In some procedures (eg, laparoscopic total hysterectomy without lymphadenectomy), thromboembolism and bleeding risks are similar, and decisions depend on individual risk prediction and values and preferences regarding venous thromboembolism and bleeding.

The experience of women reporting damage from vaginal mesh: a reflexive thematic analysis.

Background: The UK's 'First do no harm' report highlighted missed opportunities to prevent harm and emphasised the need to incorporate patient voices into healthcare. Due to concerns about, and the subsequent suspension, of vaginal mesh for urinary incontinence thousands of women face the decision about mesh removal surgery. The aim of this study was to explore and understand the experience of living with complications attributed to vaginal mesh surgery so that this knowledge can contribute to improvements in care for those considering mesh, or mesh removal, surgery. Methods: This study was embedded in the 'PURSUE' study which explored the experiences of 74 people with urogynaecological conditions in the UK (30th April 2021-17th December 2021). Of these 74 people, fifteen women reported complications that they attributed to vaginal mesh surgery. We used the six stages of reflexive thematic analysis to conceptualise these fifteen accounts. Findings: Our conceptual model anchors eight themes around two dualities: (1) body parts versus body whole, (2) dominant discourse versus marginal discourse. Our themes indicate that trust can be established through: (1) embodied healthcare that focuses on connecting with patients' lived experience, (2) dialectic communication that recognises patient experiences and remains open to alternative perspectives. Interpretation: This study raises some important issues for education and practice. Our findings can translate to other health settings where treatments aimed to provide care have caused harm. Funding: NIHR Policy Research Programme (NIHR202450).

Experiences of urinary tract infection: A systematic review and meta-ethnography.

AIM: To understand the experience of urinary tract infection (UTI) by synthesizing primary qualitative research findings and developing a conceptual model that illustrates this experience. METHOD: A systematic search of Medline, PsychInfo, Embase, and CINAHL from inception to August 2020 to find qualitative research exploring the experience of UTI. Qualitative evidence synthesis in the form of meta-ethnography was undertaken. Findings are reported in keeping with eMERGe guidance. RESULTS: We included 16 qualitative studies in the synthesis of evidence, providing data from over 1038 participants aged 13-97 years. We developed nine themes: the impact of UTI on my whole body; impact on quality of life, activities, and the associated psychological toll; I know my body and my experience has taught me when I need to seek care; worry and the transition to medicalization; antibiotics are a valuable treatment approach; antibiotics are a last resort; being heard, seen, and cared for with dignity; self-judgment; and the end of the road, a need for information and cure. These themes supported a conceptual model to illustrate the patient experience of UTI. CONCLUSIONS: The conceptual model communicates the wide and varied symptoms of patients' UTI experiences and how they process this and make care decision based on past health experiences. For some, there appears to be a sense of hopelessness and frustration. This model may be used to highlight the need for improvements in diagnostic and treatment pathways. Future research to further understand the nuances of acute, recurrent, and persistent UTI is needed.

Laparoscopic removal of a synthetic retropubic mid-urethral sling (tension-free vaginal tape): step-by-step technique.

INTRODUCTION AND HYPOTHESIS: The synthetic mid-urethral sling (MUS) has been the pre-eminent surgical treatment option for stress urinary incontinence (SUI) in women in recent times. However, increasing numbers of patients are now requesting mesh removal, secondary to persisting symptoms attributed to their sling. We present a video demonstrating a combined vaginal and laparoscopic approach to this procedure; along with supporting information outlining essential pre-operative assessment, counselling, and governance considerations. METHODS: A 60-year-old woman presented with a 4-year history of pelvic pain. She ascribed this to her retropubic MUS (a tension-free vaginal tape). Following extensive work-up, the mesh was removed using the technique described. RESULTS: On review, 3 months post-operatively, the patient reported improvement in the vaginal discomfort she had experienced prior to the procedure-albeit with concomitant deterioration in her SUI. CONCLUSIONS: An open or laparoscopic approach can be employed to dissect out the retropubic arms of an MUS. The latter provides a superior view of the retropubic space and confers potential advantages regarding recovery and cosmesis. The surgical technique detailed is safe and effective, especially when augmented by thorough preparation and patient counselling.

Laparoscopic sacrohysteropexy versus vaginal hysterectomy and apical suspension: 7-year follow-up of a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Laparoscopic mesh sacrohysteropexy offers a uterine-sparing alternative to vaginal hysterectomy with apical suspension, although randomised comparative data are lacking. This study was aimed at comparing the long-term efficacy of laparoscopic mesh sacrohysteropexy and vaginal hysterectomy with apical suspension for the treatment of uterine prolapse. METHODS: A randomised controlled trial comparing laparoscopic mesh sacrohysteropexy and vaginal hysterectomy with apical suspension for the treatment of uterine prolapse was performed, with a minimum follow-up of 7 years. The primary outcome was reoperation for apical prolapse. Secondary outcomes included patient-reported mesh complications, Pelvic Organ Prolapse Quantification, Patient Global Impression of Improvement in prolapse symptoms and the International Consultation on Incontinence Questionnaire Vaginal Symptoms, Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and PISQ-12 questionnaires. RESULTS: A total of 101 women were randomised and 62 women attended for follow-up at a mean of 100 months postoperatively (range 84-119 months). None reported a mesh-associated complication. The risk of reoperation for apical prolapse was 17.2% following vaginal hysterectomy (VH) and 6.1% following laparoscopic mesh sacrohysteropexy (LSH; relative risk 0.34, 95% CI 0.07-1.68, p = 0.17). Laparoscopic sacrohysteropexy was associated with a statistically significantly higher apical suspension (POP-Q point C -5 vs -4.25, p = 0.02) and longer total vaginal length (9 cm vs 6 cm, p < 0.001). There was no difference in the change in ICIQ-VS scores between the two groups (ICIQ-VS change -22 vs -25, p = 0.59). CONCLUSION: Laparoscopic sacrohysteropexy and vaginal hysterectomy with apical suspension have comparable reoperation rates and subjective outcomes. Potential advantages of laparoscopic sacrohysteropexy include a lower risk of apical reoperation, greater apical support and increased total vaginal length.

Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology.

BACKGROUND: Venous thromboembolism (VTE) and bleeding are serious and potentially fatal complications of surgical procedures. Pharmacological thromboprophylaxis decreases the risk of VTE but increases the risk of major post-operative bleeding. The decision to use pharmacologic prophylaxis therefore represents a trade-off that critically depends on the incidence of VTE and bleeding in the absence of prophylaxis. These baseline risks vary widely between procedures, but their magnitude is uncertain. Systematic reviews addressing baseline risks are scarce, needed, and require innovations in methodology. Indeed, systematic summaries of these baseline risk estimates exist neither in general nor gynecologic surgery. We will fill this knowledge gap by performing a series of systematic reviews and meta-analyses of the procedure-specific and patient risk factor stratified risk estimates in general and gynecologic surgeries. METHODS: We will perform comprehensive literature searches for observational studies in general and gynecologic surgery reporting symptomatic VTE or bleeding estimates. Pairs of methodologically trained reviewers will independently assess the studies for eligibility, evaluate the risk of bias by using an instrument developed for this review, and extract data. We will perform meta-analyses and modeling studies to adjust the reported risk estimates for the use of thromboprophylaxis and length of follow up. We will derive the estimates of risk from the median estimates of studies rated at the lowest risk of bias. The primary outcomes are the risk estimates of symptomatic VTE and major bleeding at 4 weeks post-operatively for each procedure stratified by patient risk factors. We will apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate evidence certainty. DISCUSSION: This series of systematic reviews, modeling studies, and meta-analyses will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding in general and gynecologic surgeries. Our work advances the standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at the best estimates of risk (including modeling of the timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the GRADE approach. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021234119.

Host-biomaterial interactions in mesh complications after pelvic floor reconstructive surgery.

Polypropylene (PPL) mesh is widely used in pelvic floor reconstructive surgery for prolapse and stress urinary incontinence. However, some women, particularly those treated using transvaginal PPL mesh placement for prolapse, experience intractable pain and mesh exposure or extrusion. Explanted tissue from patients with complications following transvaginal implantation of mesh is typified by a dense fibrous capsule with an immune cell-rich infiltrate, suggesting that the host immune response has a role in transvaginal PPL mesh complications through the separate contributions of the host (patient), the biological niche within which the material is implanted and biomaterial properties of the mesh. This immune response might be strongly influenced by both the baseline inflammatory status of the patient, surgical technique and experience, and the unique hormonal, immune and microbial tissue niche of the vagina. Mesh porosity, surface area and stiffness also might have an effect on the immune and tissue response to transvaginal mesh placement. Thus, a regulatory pathway is needed for mesh development that recognizes the roles of host and biological factors in driving the immune response to mesh, as well as mandatory mesh registries and the longitudinal surveillance of patients.

Long-term mesh complications and reoperation after laparoscopic mesh sacrohysteropexy: a cross-sectional study.

INTRODUCTION AND HYPOTHESIS: The paucity of long-term safety and efficacy data to support laparoscopic mesh sacrohysteropexy is noteworthy given concerns about the use of polypropylene mesh in pelvic floor surgery. This study is aimed at determining the incidence of mesh-associated complications and reoperation following this procedure. METHODS: This was a cross-sectional postal questionnaire study of women who underwent laparoscopic mesh sacrohysteropexy between 2010 and 2018. Potential participants were identified from surgical databases of five surgeons at two tertiary urogynaecology centres in the UK. The primary outcome was patient-reported mesh complication requiring removal of hysteropexy mesh. Secondary outcomes included other mesh-associated complications, reoperation rates and Patient Global Impression of Improvement (PGI-I) in prolapse symptoms. Descriptive statistics and Kaplan-Meier survival analyses were used. RESULTS: Of 1,766 eligible participants, 1,121 women responded (response proportion 63.5%), at a median follow-up of 46 months. The incidence of mesh complications requiring removal of hysteropexy mesh was 0.4% (4 out of 1,121). The rate of chronic pain service use was 1.8%, and newly diagnosed systemic autoimmune disorders was 5.8%. The rate of reoperation for apical prolapse was 3.7%, and for any form of pelvic organ prolapse it was 13.6%. For PGI-I, 81.4% of patients were "much better" or "very much better". CONCLUSIONS: Laparoscopic mesh sacrohysteropexy has a low incidence of reoperation for mesh complications and apical prolapse, and a high rate of patient-reported improvement in prolapse symptoms. With appropriate clinical governance measures, the procedure offers an alternative to vaginal hysterectomy with apical suspension. However, long-term comparative studies are still required.