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JAMA Mar 2023The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits.
OBJECTIVE
To determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit.
DESIGN, SETTING, AND PARTICIPANTS
In this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum.
INTERVENTIONS
Early postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum.
MAIN OUTCOMES AND MEASURES
The primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome.
RESULTS
Among 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group.
CONCLUSIONS AND RELEVANCE
Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03462758.
Topics: Adult; Female; Humans; Cesarean Section; Intrauterine Device Expulsion; Intrauterine Devices; Parturition; Postpartum Period; Time Factors; Contraception; Young Adult
PubMed: 36943214
DOI: 10.1001/jama.2023.1936 -
International Journal of Environmental... Sep 2021to evaluate risk factors, causes, management and surgical therapy of postcoital vaginal perforation and evisceration in women with no prior pelvic surgery. (Review)
Review
OBJECTIVE
to evaluate risk factors, causes, management and surgical therapy of postcoital vaginal perforation and evisceration in women with no prior pelvic surgery.
DATA SOURCES
We used MEDLINE (PubMed), Scopus, Embase and Web of Science for our research. Our review includes all reports from 1980 to November 2020. The research strategy adopted included different combinations of the following terms: (intercourse) AND (coitus) AND (vaginal perforation).
METHODS OF STUDY SELECTION
we report a case of vaginal evisceration after consensual intercourse in a young and healthy woman. In addition, we performed a systematic review of vaginal perforations with or without evisceration in women without prior surgery or any other predisposing disease. All studies identified were listed by citation, title, authors and abstract. Duplicates were identified by an independent manual screening, performed by one researcher and then removed. For the eligibility process, two authors independently screened the title and abstracts of all non-duplicated papers and excluded those not pertinent to the topic.
TABULATION, INTEGRATION AND RESULTS
We have followed the PRISMA guidelines. Five manuscripts were detected through the references of the works that had been identified with the research on MEDLINE (PubMed), Scopus, Embase and Web of Science. We found 16 cases between 1980 and 2020. The young age and the virginal status represent the principal risk factors and all the lacerations occurred in the posterior vaginal fornix. The most common surgical technique was the laparotomic approach and, in the remaining cases, the laparoscopic and vaginal route was performed.
CONCLUSIONS
Post-coital vaginal perforation and evisceration in women with no prior pelvic surgery is a rare condition in the clinical practice and, when it is associated with evisceration it is a surgical emergency. Usually, these injuries are not life-threatening conditions but, a delay in diagnosis, can lead to severe complications. In consideration of the high heterogeneity of the data in the literature, it is essential to define a diagnostic-therapeutic management for the patients with vaginal perforation. With our review, we try to identify the associated risk factors, the best and fastest diagnosis, and the best surgical approach. We believe that a combined vaginal and laparoscopic approach can be the best surgical treatment, useful to diagnose injuries of the abdominal organs and to improve postoperative outcome.
Topics: Coitus; Female; Humans; Laparoscopy; Rupture; Vaginal Diseases
PubMed: 34574671
DOI: 10.3390/ijerph18189746 -
Gynecologic Oncology Feb 2021Vaginal necrosis is a late radiation tissue injury with serious morbidity complications. It is rare, and its incidence is not well assessed in prospective trials.... (Review)
Review
Vaginal necrosis is a late radiation tissue injury with serious morbidity complications. It is rare, and its incidence is not well assessed in prospective trials. Patient comorbidities and radiation dose can significantly increase the risk. As treatment of gynecologic malignancies often involve a multidisciplinary approach, timely diagnosis and appropriate management by physicians of the team are crucial. Untreated vaginal necrosis can lead to infection, hemorrhage, necrosis-related fistulation to the bladder or rectum, perforation, and death. In this review, we describe the pathophysiology of vaginal necrosis, its clinical course, and management options.
Topics: Anti-Bacterial Agents; Combined Modality Therapy; Debridement; Female; Genital Neoplasms, Female; Humans; Hydrogen Peroxide; Hyperbaric Oxygenation; Incidence; Necrosis; Radiation Injuries; Radiotherapy Dosage; Risk Factors; Treatment Outcome; Vagina; Vaginal Douching
PubMed: 33303211
DOI: 10.1016/j.ygyno.2020.11.025 -
Acta Obstetricia Et Gynecologica... Aug 2020The retropubic tension-free vaginal tape procedure has been the preferred method for primary surgical treatment of stress and stress-dominant mixed urinary incontinence...
INTRODUCTION
The retropubic tension-free vaginal tape procedure has been the preferred method for primary surgical treatment of stress and stress-dominant mixed urinary incontinence in women for more than 20 years. In this study, we assessed associations between surgeon's experience with the primary tension-free vaginal tape procedure and both perioperative complications and recurrence rates.
MATERIAL AND METHODS
Using a consecutive case-series design, we assessed 596 patients treated with primary retropubic tension-free vaginal tape surgery performed by 18 surgeons from 1998 through 2012, with follow up through 2015 (maximum follow-up time: 10 years per patient). Data on perioperative complications and recurrence of stress urinary incontinence from medical records was transferred to a case report form. Surgeon's experience with the tension-free vaginal tape procedure was defined as number of such procedures performed as lead surgeon (1-19 ["beginners"], 20-49 and ≥50 procedures). All analyses were done with a 5% level of statistical significance. We applied the Chi-square test in the assessment of perioperative complications. The regression analyses of recurrence rate by number of tension-free vaginal tape procedures performed were restricted to the three surgeons who performed ≥50 procedures.
RESULTS
We found a significantly higher rate of bladder perforations (P = .03) and a higher rate of urinary retentions among patients whose tension-free vaginal tape procedures were performed by "beginners" (P = .06). We observed a significant reduction in recurrence rates with increasing number of tension-free vaginal tape procedures for one surgeon (P = .03).
CONCLUSIONS
Surgeon's experience with the tension-free vaginal tape procedure is associated with the risk of bladder perforation and urinary retention, and may be associated with the long-term effectiveness of the procedure.
Topics: Adult; Aged; Aged, 80 and over; Clinical Competence; Female; Humans; Middle Aged; Norway; Postoperative Complications; Risk Factors; Suburethral Slings; Urinary Bladder; Urinary Incontinence, Stress; Urinary Retention; Urologic Surgical Procedures
PubMed: 32104906
DOI: 10.1111/aogs.13830 -
Frontiers in Medicine 2023Graft-versus-host disease (GVHD) is characterized by tissue inflammation in the host following an allogeneic hematopoietic cell transplantation (HCT). The... (Review)
Review
Graft-versus-host disease (GVHD) is characterized by tissue inflammation in the host following an allogeneic hematopoietic cell transplantation (HCT). The pathophysiology is complex and only incompletely understood yet. Donor lymphocyte interaction with the histocompatibility antigens of the host plays a crucial role in the pathogenesis of the disease. Inflammation may affect multiple organs and tissues, e.g., the gastrointestinal tract, liver, lung, fasciae, vaginal mucosa, and the eye. Subsequently, alloreactive donor-derived T and B lymphocytes may lead to severe inflammation of the ocular surface (i.e., cornea and conjunctiva) and the eyelids. Furthermore, fibrosis of the lacrimal gland may lead to severe dry eye. This review focuses on ocular GVHD (oGVHD) and provides an overview of current challenges and concepts in the diagnosis and management of oGVHD. Ophthalmic manifestations, diagnostic procedures, grading of severity and recommendations for ophthalmic examination intervals are provided. Management of ocular surface disease with lubricants, autologous serum eye drops, topical anti-inflammatory agents and systemic treatment options are described based on the current evidence. Ocular surface scarring and corneal perforation are severe complications of oGVHD. Therefore, ophthalmic screening and interdisciplinary treatment approaches are highly relevant to improve the quality of life of patients and to prevent potentially irreversible visual loss.
PubMed: 36891189
DOI: 10.3389/fmed.2023.1133381 -
Acta Obstetricia Et Gynecologica... Mar 2021To reduce the risk of avoidable damage to the patient when training surgeons, one must predefine what standards to achieve, as well as supervise and monitor trainees'...
INTRODUCTION
To reduce the risk of avoidable damage to the patient when training surgeons, one must predefine what standards to achieve, as well as supervise and monitor trainees' performance. The aim of this study is to establish a quality reference, to devise comprehensive tension-free vaginal tape (TVT) learning curves and to compare trainees' results to our quality reference.
MATERIAL AND METHODS
Using the Swedish National Quality Register for Gynecologic Surgery, we devised TVT learning curves for all Swedish TVT trainees from 2009 to 2017, covering their first 50 operations. These outcomes were compared with the results of Sweden's most experienced TVT surgeons for 14 quality variables.
RESULTS
In all, 163 trainees performed 2804 operations and 40 experienced surgeons performed 3482 operations. For our primary outcomes - perioperative bladder perforations and urinary continence after 1 year - as well as re-admission, re-operation and days to all daily living activities, there was no statistically significant difference between trainees and experienced surgeons at any time. For the first 10 trainee operations only, there were small differences in favor of the experienced surgeons: patient-reported minor complications after discharge (14% vs 18.4%, P = .002), 1-year patient-reported improvement (95.9% vs 91.8%, P < .000), and patient satisfaction (90.9% vs 86.2%, P = .002). For both trainee operations 1-10 and 11-50, compared with experienced surgeons, operation time (33.8 vs 22.2 min, P < .000; 28.3 vs 22.2 min, P < .000) and hospital stay time (0.16 vs 0.06 days, P < .001; 0.1 vs 0.06 days, P < .001) were longer, perioperative blood loss was higher (27.7 vs 24.4 mL, P = .001; 26.5 vs 24.4 mL, P = .004), and patient-reported catheterization within 8 weeks was higher (3.9% vs 1.8%, P < .000; 2.5% vs 1.8%, P = .001). One-year voiding difficulties for trainee patients (operations 1-10:14.2%, P = .260; operations 11-50:14.5%, P = .126) were comparable to the experienced surgeons (12.4%).
CONCLUSIONS
There is a learning curve for several secondary outcomes but the small effect size makes it improbable that the difference has clinical significance. Our national Swedish results show that it is possible to train new TVT surgeons without exposing patients to noteworthy extra risk and achieve results which are equivalent to the most experienced Swedish surgeons.
Topics: Activities of Daily Living; Clinical Competence; Female; Humans; Learning Curve; Middle Aged; Patient Readmission; Patient Satisfaction; Postoperative Complications; Registries; Reoperation; Risk Factors; Suburethral Slings; Sweden; Urinary Bladder; Urinary Incontinence
PubMed: 33111326
DOI: 10.1111/aogs.14033 -
Therapeutic Advances in Urology 2020Mesh was a promising, minimally invasive, and 'gold standard' treatment for urinary stress incontinence. Time has shown that complications from these devices can happen... (Review)
Review
Mesh was a promising, minimally invasive, and 'gold standard' treatment for urinary stress incontinence. Time has shown that complications from these devices can happen early, or even several years, after mesh placement and can be catastrophic. Pain, erosion, voiding dysfunction, infection, recurrent UTIs [urinary tract infections (UTIs)], fistulae, organ perforation, bleeding, vaginal scarring, neuromuscular alterations, LUTS (lower urinary tract symptoms), bowel complications and even immune disorders have been linked to mesh. Various tools, such as imaging, endoscopic and functional studies, are available for diagnosis of mesh complications. Since the spectrum of complications is wide, involvement of other specialties is usually beneficial in the diagnosis and management of these complications. There is still much to learn on the accuracy and utility of diagnostic studies in each type of complication. Evidence on the best diagnostic and treatment pathways for these complications is scarce but continuously growing as information is being reported, and we continue to gain expertise in dealing with patients affected by mesh. Treatment options include conservative and medical management initially and then open or minimally invasive surgical procedure approaches. This article will describe diagnostic and treatment pathways for mesh complications.
PubMed: 32754226
DOI: 10.1177/1756287220942993