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1.
N Engl J Med ; 386(15): 1409-1420, 2022 04 14.
Article in English | MEDLINE | ID: mdl-35417636

ABSTRACT

BACKGROUND: Whether surgical repair of an acute Achilles' tendon rupture by an open-repair or minimally invasive approach is associated with better outcomes than nonsurgical treatment is not clear. METHODS: We performed a multicenter, randomized, controlled trial that compared nonoperative treatment, open repair, and minimally invasive surgery in adults with acute Achilles' tendon rupture who presented to four trial centers. The primary outcome was the change from baseline in the Achilles' tendon Total Rupture Score (scores range from 0 to 100, with higher scores indicating better health status) at 12 months. Secondary outcomes included the incidence of tendon rerupture. RESULTS: A total of 554 patients underwent randomization, and 526 patients were included in the final analysis. The mean changes in the Achilles' tendon Total Rupture Score were -17.0 points in the nonoperative group, -16.0 points in the open-repair group, and -14.7 points in the minimally invasive surgery group (P = 0.57). Pairwise comparisons provided no evidence of differences between the groups. The changes from baseline in physical performance and patient-reported physical function were similar in the three groups. The number of tendon reruptures was higher in the nonoperative group (6.2%) than in the open-repair or minimally invasive surgery group (0.6% in each). There were 9 nerve injuries in the minimally invasive surgery group (in 5.2% of the patients) as compared with 5 in the open-repair group (in 2.8%) and 1 in the nonoperative group (in 0.6%). CONCLUSIONS: In patients with Achilles' tendon rupture, surgery (open repair or minimally invasive surgery) was not associated with better outcomes than nonoperative treatment at 12 months. (Funded by the South-Eastern Norway Regional Health Authority and Akershus University Hospital; ClinicalTrials.gov number, NCT01785264.).


Subject(s)
Achilles Tendon , Ankle Injuries , Tendon Injuries , Achilles Tendon/injuries , Achilles Tendon/surgery , Acute Disease , Adult , Ankle Injuries/surgery , Ankle Injuries/therapy , Conservative Treatment , Humans , Minimally Invasive Surgical Procedures , Rupture/surgery , Rupture/therapy , Tendon Injuries/surgery , Tendon Injuries/therapy , Treatment Outcome
2.
Blood ; 141(1): 60-71, 2023 01 05.
Article in English | MEDLINE | ID: mdl-36167031

ABSTRACT

Allogeneic hematopoietic stem cell transplantation (alloSCT) is curative for severe inborn errors of immunity (IEIs), with recent data suggesting alloSCT in adulthood is safe and effective in selected patients. However, questions remain regarding the indications for and optimal timing of transplant. We retrospectively compared outcomes of transplanted vs matched nontransplanted adults with severe IEIs. Seventy-nine patients (aged ≥ 15 years) underwent alloSCT between 2008 and 2018 for IEIs such as chronic granulomatous disease (n = 20) and various combined immune deficiencies (n = 59). A cohort of nontransplanted patients from the French Centre de Référence Déficits Immunitaires Héréditaires registry was identified blindly for case-control analysis, with ≤3 matched controls per index patient, without replacement. The nontransplanted patients were matched for birth decade, age at last review greater than index patient age at alloSCT, chronic granulomatous disease or combined immune deficiencies, and autoimmune/lymphoproliferative complications. A total of 281 patients were included (79 transplanted, 202 nontransplanted). Median age at transplant was 21 years. Transplant indications were mainly lymphoproliferative disease (n = 23) or colitis (n = 15). Median follow-up was 4.8 years (interquartile range, 2.5-7.2). One-year transplant-related mortality rate was 13%. Estimated disease-free survival at 5 years was higher in transplanted patients (58% vs 33%; P = .007). Nontransplanted patients had an ongoing risk of severe events, with an increased mean cumulative number of recurrent events compared with transplanted patients. Sensitivity analyses removing patients with common variable immune deficiency and their matched transplanted patients confirm these results. AlloSCT prevents progressive morbidity associated with IEIs in adults, which may outweigh the negative impact of transplant-related mortality.


Subject(s)
Graft vs Host Disease , Granulomatous Disease, Chronic , Hematopoietic Stem Cell Transplantation , Humans , Adult , Young Adult , Retrospective Studies , Granulomatous Disease, Chronic/therapy , Conservative Treatment , Transplantation, Homologous/methods , Hematopoietic Stem Cell Transplantation/methods , Stem Cell Transplantation/methods , Transplantation Conditioning/methods , Graft vs Host Disease/etiology
3.
Ann Intern Med ; 177(3): JC27, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38437689

ABSTRACT

SOURCE CITATION: Berg ES, Tegn NK, Abdelnoor M, et al; After Eighty Study Investigators. Long-term outcomes of invasive vs conservative strategies for older patients with non-ST-segment elevation acute coronary syndromes. J Am Coll Cardiol. 2023;82:2021-2030. 37968019.


Subject(s)
Acute Coronary Syndrome , Conservative Treatment , Humans , Acute Coronary Syndrome/therapy , Treatment Outcome
4.
Eur Heart J ; 45(23): 2052-2062, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38596853

ABSTRACT

BACKGROUND AND AIMS: Older patients with non-ST-elevation acute coronary syndrome (NSTEACS) are less likely to receive guideline-recommended care including coronary angiography and revascularization. Evidence-based recommendations regarding interventional management strategies in this patient cohort are scarce. This meta-analysis aimed to assess the impact of routine invasive vs. conservative management of NSTEACS by using individual patient data (IPD) from all available randomized controlled trials (RCTs) including older patients. METHODS: MEDLINE, Web of Science and Scopus were searched between 1 January 2010 and 11 September 2023. RCTs investigating routine invasive and conservative strategies in persons >70 years old with NSTEACS were included. Observational studies or trials involving populations outside the target range were excluded. The primary endpoint was a composite of all-cause mortality and myocardial infarction (MI) at 1 year. One-stage IPD meta-analyses were adopted by use of random-effects and fixed-effect Cox models. This meta-analysis is registered with PROSPERO (CRD42023379819). RESULTS: Six eligible studies were identified including 1479 participants. The primary endpoint occurred in 181 of 736 (24.5%) participants in the invasive management group compared with 215 of 743 (28.9%) participants in the conservative management group with a hazard ratio (HR) from random-effects model of 0.87 (95% CI 0.63-1.22; P = .43). The hazard for MI at 1 year was significantly lower in the invasive group compared with the conservative group (HR from random-effects model 0.62, 95% CI 0.44-0.87; P = .006). Similar results were seen for urgent revascularization (HR from random-effects model 0.41, 95% CI 0.18-0.95; P = .037). There was no significant difference in mortality. CONCLUSIONS: No evidence was found that routine invasive treatment for NSTEACS in older patients reduces the risk of a composite of all-cause mortality and MI within 1 year compared with conservative management. However, there is convincing evidence that invasive treatment significantly lowers the risk of repeat MI or urgent revascularisation. Further evidence is needed from ongoing larger clinical trials.


Subject(s)
Acute Coronary Syndrome , Conservative Treatment , Percutaneous Coronary Intervention , Humans , Conservative Treatment/methods , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/mortality , Aged , Randomized Controlled Trials as Topic , Myocardial Revascularization/statistics & numerical data , Coronary Angiography , Non-ST Elevated Myocardial Infarction/therapy , Non-ST Elevated Myocardial Infarction/mortality , Female
5.
Eur Heart J ; 45(27): 2380-2391, 2024 Jul 12.
Article in English | MEDLINE | ID: mdl-38805681

ABSTRACT

BACKGROUND AND AIMS: A routine invasive strategy is recommended in the management of higher risk patients with non-ST-elevation acute coronary syndromes (NSTE-ACSs). However, patients with previous coronary artery bypass graft (CABG) surgery were excluded from key trials that informed these guidelines. Thus, the benefit of a routine invasive strategy is less certain in this specific subgroup. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted. A comprehensive search was performed of PubMed, EMBASE, Cochrane, and ClinicalTrials.gov. Eligible studies were RCTs of routine invasive vs. a conservative or selective invasive strategy in patients presenting with NSTE-ACS that included patients with previous CABG. Summary data were collected from the authors of each trial if not previously published. Outcomes assessed were all-cause mortality, cardiac mortality, myocardial infarction, and cardiac-related hospitalization. Using a random-effects model, risk ratios (RRs) with 95% confidence intervals (CIs) were calculated. RESULTS: Summary data were obtained from 11 RCTs, including previously unpublished subgroup outcomes of nine trials, comprising 897 patients with previous CABG (477 routine invasive, 420 conservative/selective invasive) followed up for a weighted mean of 2.0 (range 0.5-10) years. A routine invasive strategy did not reduce all-cause mortality (RR 1.12, 95% CI 0.97-1.29), cardiac mortality (RR 1.05, 95% CI 0.70-1.58), myocardial infarction (RR 0.90, 95% CI 0.65-1.23), or cardiac-related hospitalization (RR 1.05, 95% CI 0.78-1.40). CONCLUSIONS: This is the first meta-analysis assessing the effect of a routine invasive strategy in patients with prior CABG who present with NSTE-ACS. The results confirm the under-representation of this patient group in RCTs of invasive management in NSTE-ACS and suggest that there is no benefit to a routine invasive strategy compared to a conservative approach with regard to major adverse cardiac events. These findings should be validated in an adequately powered RCT.


Subject(s)
Acute Coronary Syndrome , Conservative Treatment , Coronary Artery Bypass , Randomized Controlled Trials as Topic , Humans , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/surgery , Conservative Treatment/methods , Non-ST Elevated Myocardial Infarction/surgery , Non-ST Elevated Myocardial Infarction/therapy , Non-ST Elevated Myocardial Infarction/mortality , Percutaneous Coronary Intervention/methods
6.
Eur Heart J ; 45(26): 2306-2316, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38751052

ABSTRACT

BACKGROUND AND AIMS: Presentation, outcome, and management of females with degenerative mitral regurgitation (DMR) are undefined. We analysed sex-specific baseline clinical and echocardiographic characteristics at referral for DMR due to flail leaflets and subsequent management and outcomes. METHODS: In the Mitral Regurgitation International Database (MIDA) international registry, females were compared with males regarding presentation at referral, management, and outcome (survival/heart failure), under medical treatment, post-operatively, and encompassing all follow-up. RESULTS: At referral, females (n = 650) vs. males (n = 1660) were older with more severe symptoms and higher MIDA score. Smaller cavity diameters belied higher cardiac dimension indexed to body surface area. Under conservative management, excess mortality vs. expected was observed in males [standardized mortality ratio (SMR) 1.45 (1.27-1.65), P < .001] but was higher in females [SMR 2.00 (1.67-2.38), P < .001]. Female sex was independently associated with mortality [adjusted hazard ratio (HR) 1.29 (1.04-1.61), P = .02], cardiovascular mortality [adjusted HR 1.58 (1.14-2.18), P = .007], and heart failure [adjusted HR 1.36 (1.02-1.81), P = .04] under medical management. Females vs. males were less offered surgical correction (72% vs. 80%, P < .001); however, surgical outcome, adjusted for more severe presentation in females, was similar (P ≥ .09). Ultimately, overall outcome throughout follow-up was worse in females who displayed persistent excess mortality vs. expected [SMR 1.31 (1.16-1.47), P < .001], whereas males enjoyed normal life expectancy restoration [SMR 0.92 (0.85-0.99), P = .036]. CONCLUSIONS: Females with severe DMR were referred to tertiary centers at a more advanced stage, incurred higher mortality and morbidity under conservative management, and were offered surgery less and later after referral. Ultimately, these sex-related differences yielded persistent excess mortality despite surgery in females with DMR, while males enjoyed restoration of life expectancy, warranting imperative re-evaluation of sex-specific DMR management.


Subject(s)
Mitral Valve Insufficiency , Humans , Female , Male , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/surgery , Aged , Sex Factors , Middle Aged , Echocardiography , Registries , Treatment Outcome , Conservative Treatment , Heart Failure/mortality , Heart Failure/therapy , Heart Failure/etiology , Mitral Valve/surgery , Mitral Valve/diagnostic imaging
7.
Circulation ; 147(1): 8-19, 2023 01 03.
Article in English | MEDLINE | ID: mdl-36335918

ABSTRACT

BACKGROUND: The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes during a median of 3.2 years. Extended follow-up for mortality is ongoing. METHODS: ISCHEMIA participants were randomized to an initial invasive strategy added to guideline-directed medical therapy or a conservative strategy. Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and noncardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models, and Bayesian methods. Undetermined deaths were classified as cardiovascular as prespecified in the trial protocol. RESULTS: Baseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23% women, 16% Hispanic, 4% Black, 42% with diabetes, and median ejection fraction 0.60. A total of 557 deaths accrued during a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 noncardiovascular deaths, and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate, 12.7% in invasive strategy, 13.4% in conservative strategy; adjusted hazard ratio, 1.00 [95% CI, 0.85-1.18]). There was a lower 7-year rate cardiovascular mortality (6.4% versus 8.6%; adjusted hazard ratio, 0.78 [95% CI, 0.63-0.96]) with an initial invasive strategy but a higher 7-year rate of noncardiovascular mortality (5.6% versus 4.4%; adjusted hazard ratio, 1.44 [95% CI, 1.08-1.91]) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease. CONCLUSIONS: There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04894877.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Humans , Female , Aged , Male , Conservative Treatment , Bayes Theorem , Coronary Artery Disease/therapy , Acute Coronary Syndrome/therapy , Treatment Outcome
8.
Kidney Int ; 105(1): 35-45, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38182300

ABSTRACT

Integrated kidney care requires synergistic linkage between preventative care for people at risk for chronic kidney disease and health services providing care for people with kidney disease, ensuring holistic and coordinated care as people transition between acute and chronic kidney disease and the 3 modalities of kidney failure management: conservative kidney management, transplantation, and dialysis. People with kidney failure have many supportive care needs throughout their illness, regardless of treatment modality. Kidney supportive care is therefore a vital part of this integrated framework, but is nonexistent, poorly developed, and/or poorly integrated with kidney care in many settings, especially in low- and middle-income countries. To address this, the International Society of Nephrology has (i) coordinated the development of consensus definitions of conservative kidney management and kidney supportive care to promote international understanding and awareness of these active treatments; and (ii) identified key considerations for the development and expansion of conservative kidney management and kidney supportive care programs, especially in low resource settings, where access to kidney replacement therapy is restricted or not available. This article presents the definitions for conservative kidney management and kidney supportive care; describes their core components with some illustrative examples to highlight key points; and describes some of the additional considerations for delivering conservative kidney management and kidney supportive care in low resource settings.


Subject(s)
Delivery of Health Care, Integrated , Renal Insufficiency, Chronic , Renal Insufficiency , Humans , Kidney , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/therapy , Conservative Treatment
9.
Ann Surg ; 279(5): 746-754, 2024 May 01.
Article in English | MEDLINE | ID: mdl-37991178

ABSTRACT

OBJECTIVE: Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND: Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS: The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS: After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS: SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.


Subject(s)
Conservative Treatment , Electric Stimulation Therapy , Adult , Adolescent , Humans , Quality of Life , Constipation/therapy , Electric Stimulation Therapy/adverse effects , Treatment Outcome
10.
Lancet ; 401(10393): 2051-2059, 2023 06 17.
Article in English | MEDLINE | ID: mdl-37209706

ABSTRACT

BACKGROUND: Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis. METHODS: This pragmatic multicentre, open-label, randomised controlled trial was conducted in 27 hospitals in the UK. Participants were adults aged 16 years or older who were newly referred to secondary care otolaryngology clinics with recurrent acute tonsillitis. Patients were randomly assigned (1:1) to receive tonsillectomy or conservative management using random permuted blocks of variable length. Stratification by recruiting centre and baseline symptom severity was assessed using the Tonsil Outcome Inventory-14 score (categories defined as mild 0-35, moderate 36-48, or severe 49-70). Participants in the tonsillectomy group received elective surgery to dissect the palatine tonsils within 8 weeks after random assignment and those in the conservative management group received standard non-surgical care during 24 months. The primary outcome was the number of sore throat days collected during 24 months after random assignment, reported once per week with a text message. The primary analysis was done in the intention-to-treat (ITT) population. This study is registered with the ISRCTN registry, 55284102. FINDINGS: Between May 11, 2015, and April 30, 2018, 4165 participants with recurrent acute tonsillitis were assessed for eligibility and 3712 were excluded. 453 eligible participants were randomly assigned (233 in the immediate tonsillectomy group vs 220 in the conservative management group). 429 (95%) patients were included in the primary ITT analysis (224 vs 205). The median age of participants was 23 years (IQR 19-30), with 355 (78%) females and 97 (21%) males. Most participants were White (407 [90%]). Participants in the immediate tonsillectomy group had fewer days of sore throat during 24 months than those in the conservative management group (median 23 days [IQR 11-46] vs 30 days [14-65]). After adjustment for site and baseline severity, the incident rate ratio of total sore throat days in the immediate tonsillectomy group (n=224) compared with the conservative management group (n=205) was 0·53 (95% CI 0·43 to 0·65; <0·0001). 191 adverse events in 90 (39%) of 231 participants were deemed related to tonsillectomy. The most common adverse event was bleeding (54 events in 44 [19%] participants). No deaths occurred during the study. INTERPRETATION: Compared with conservative management, immediate tonsillectomy is clinically effective and cost-effective in adults with recurrent acute tonsillitis. FUNDING: National Institute for Health Research.


Subject(s)
Pharyngitis , Respiration Disorders , Tonsillectomy , Tonsillitis , Male , Female , Humans , Adult , Young Adult , Tonsillectomy/adverse effects , Conservative Treatment , Tonsillitis/surgery , Tonsillitis/complications , Pharyngitis/etiology , Pain/etiology , United Kingdom/epidemiology
11.
J Urol ; 211(3): 354-363, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38079459

ABSTRACT

PURPOSE: We evaluate the efficacy and safety profiles of currently available conservative management options for penile and urethral lichen sclerosus. MATERIALS AND METHODS: A systematic review of existing literature on lichen sclerosus was conducted utilizing the PubMed, Embase, and Web of Science databases. References were assessed for relevance to nonsurgical management of male genital lichen sclerosus by title and abstract by 3 independent reviewers, then reviewed in full and in duplicate by 5 independent reviewers. RESULTS: Seventeen studies describing conservative management of histologically confirmed penile and urethral lichen sclerosus in male patients were included in the final review. We present available evidence supporting the use of 4 major treatment modalities represented in the existing literature: topical corticosteroids, tacrolimus, platelet-rich plasma, and CO2 laser. We also briefly discuss the limited studies on the use of oral acitretin and polydeoxyribonucleotide injections. Outcomes assessed include symptoms, clinical appearance, quality of life, sexual satisfaction, adverse effects, and long-term efficacy of treatment. CONCLUSIONS: Topical corticosteroids remain the mainstay of conservative management of penile and urethral lichen sclerosus, with current literature supporting the use of other therapies such as tacrolimus and platelet-rich plasma as alternatives or adjuvant treatments when escalation of treatment is necessary. Future research should further explore the efficacy and safety of newer therapies through additional controlled clinical trials in the targeted population.


Subject(s)
Lichen Sclerosus et Atrophicus , Urethral Stricture , Humans , Male , Lichen Sclerosus et Atrophicus/drug therapy , Tacrolimus/therapeutic use , Conservative Treatment , Quality of Life , Urethral Stricture/surgery , Glucocorticoids
12.
Hum Reprod ; 39(6): 1231-1238, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38719783

ABSTRACT

STUDY QUESTION: What are the pregnancy and obstetric outcomes in women with atypical hyperplasia (AH) or early-stage endometrial cancer (EC) managed conservatively for fertility preservation? SUMMARY ANSWER: The study found a live birth rate of 62% in patients with AH or EC after conservative treatment, with higher level of labour induction, caesarean section, and post-partum haemorrhage. WHAT IS KNOWN ALREADY: Fertility-sparing treatment is a viable option for women with AH or EC during childbearing years, but the outcomes of such treatments, especially regarding pregnancy and obstetrics, need further exploration. STUDY DESIGN, SIZE, DURATION: This retrospective cohort study analysed data from January 2010 to October 2022, involving 269 patients from the French national register of patients with fertility-sparing management of AH/EC. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women above 18 years of age, previously diagnosed with AH/EC, and approved for fertility preservation were included. Patients were excluded if they were registered before 2010, if their treatment began <6 months before the study, or if no medical record on the pregnancy was available. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 95 pregnancies in 67 women were observed. Pregnancy was achieved using ART in 63 cases (66%) and the live birth rate was 62%, with early and late pregnancy loss at 26% and 5%, respectively. In the 59 cases resulting in a live birth, a full-term delivery occurred in 90% of cases; 36% of cases required labour induction and 39% of cases required a caesarean section. The most common maternal complications included gestational diabetes (17%) and post-partum haemorrhaging (20%). The average (±SD) birthweight was 3110 ± 736 g; there were no significant foetal malformations in the sample. No significant difference was found in pregnancy or obstetric outcomes between ART-obtained and spontaneous pregnancies. However, the incidence of induction of labour, caesarean section, and post-partum haemorrhage appears higher than in the general population. LIMITATIONS, REASONS FOR CAUTION: The retrospective nature of the study may introduce bias, and the sample size might be insufficient for assessing rare obstetric complications. WIDER IMPLICATIONS OF THE FINDINGS: This study offers valuable insights for healthcare providers to guide patients who received fertility-sparing treatments for AH/EC. These pregnancies can be successful and with an acceptable live birth rate, but they seem to be managed with caution, leading to possible tendency for more caesarean sections and labour inductions. No increase in adverse obstetric outcomes was observed, with the exception of suspicion of a higher risk of post-partum haemorrhaging, to be confirmed. STUDY FUNDING/COMPETING INTEREST(S): No funding was received for this study. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: N/A.


Subject(s)
Cesarean Section , Endometrial Neoplasms , Fertility Preservation , Pregnancy Outcome , Humans , Female , Pregnancy , Fertility Preservation/methods , Adult , Retrospective Studies , Endometrial Neoplasms/therapy , Endometrial Neoplasms/complications , Endometrial Hyperplasia/therapy , Endometrial Hyperplasia/complications , Live Birth , Pregnancy Rate , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Postpartum Hemorrhage/prevention & control , France/epidemiology , Birth Rate , Conservative Treatment/methods , Labor, Induced , Reproductive Techniques, Assisted
13.
Osteoporos Int ; 35(5): 795-804, 2024 May.
Article in English | MEDLINE | ID: mdl-38261013

ABSTRACT

Teriparatide and denosumab, anti-osteoporosis medications with different mechanisms, have been widely used in the patients with osteoporotic vertebral fracture (OVF) considered as advanced osteoporosis. Teriparatide has been shown to enhance bone formation and fracture healing in OVF, but there are still no sufficient evidences discussing about the role of denosumab in newly developed OVF. In this study, we found the similar radiological deformation and functional outcomes of conservative treatment with teriparatide and denosumab in thoracolumbar (TL) OVF, and teriparatide showed a more frequent incidence of fracture union with paravertebral bone bridge formation compared to denosumab. INTRODUCTION: Teriparatide and denosumab have been widely used to treat advanced osteoporosis and prevent subsequent fractures in patients with OVCF. Unlike teriparatide, which is considered to be effective in fracture healing, there is still no clear role and evidence for the effect of denosumab in acute OVCF. This study compared the radiological and functional outcomes of conservative treatment with teriparatide and denosumab in TL-OVF. METHODS: This retrospective study enrolled 78 women with mean age of 74.69 ± 7.66 (60-92) years diagnosed as a TL-OVF with no neurological deficits. All patients were treated conservatively with teriparatide (34 of group T, once-daily 20 µg) or denosumab (44 of group D, once-6 months 60 mg) for 6 months. We evaluated the radiological deformation (kyphotic angle, segmental vertebral kyphotic angle, and compression ratio) and the incidence of fracture union with paravertebral bone bridge formation (FUPB) and functional outcomes using the visual analog scale (VAS) and Oswestry Disability Index (ODI) at 0, 3, and 6 months. RESULTS: In the radiological deformation and functional outcomes, there were no significant differences at 0, 3, and 6 months between the two groups (P > 0.05). However, the incidence of FUPB at 6 months was higher in group T (20/34, 58.8%) compared to group D (11/44, 25.0%) (P = 0.004), and teriparatide was the most statistically significant factor for achieving FUPB (OR 4.486, P = 0.012) in multivariable logistic analysis. CONCLUSIONS: Teriparatide and denosumab, despite of their different pharmacological mechanisms, showed similar radiological deformation and functional outcomes in the conservative treatment of TL-OVF. However, teriparatide showed a significantly higher incidence of fracture union with paravertebral bone bridge formation.


Subject(s)
Bone Density Conservation Agents , Osteoporosis , Osteoporotic Fractures , Spinal Fractures , Humans , Female , Aged , Aged, 80 and over , Teriparatide/therapeutic use , Denosumab/therapeutic use , Spinal Fractures/diagnostic imaging , Spinal Fractures/etiology , Spinal Fractures/drug therapy , Bone Density Conservation Agents/therapeutic use , Retrospective Studies , Conservative Treatment/adverse effects , Osteoporotic Fractures/diagnostic imaging , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/drug therapy , Osteoporosis/drug therapy
14.
J Neural Transm (Vienna) ; 131(1): 43-51, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37831150

ABSTRACT

Isolated cervical dystonia is a focal, idiopathic dystonia affecting the neck muscles. Treatment usually consists of botulinum neurotoxin (BoNT) injections into the dystonic muscles. Our aim is to investigate the use of BoNT treatment and conservative treatments by people living with cervical dystonia. An online survey in English was conducted between June and August 2022. Participants were eligible to participate if they were living with cervical dystonia, were over 18 years old and could read and understand English. The survey consisted of demographic questions, characteristics of dystonia, questions relating to BoNT use and the perceived utility of conservative treatments. The data were analysed descriptively, and open-ended questions were grouped into similar topics represented by direct quotes. We received 128 responses from people with cervical dystonia, with an average age of 59 years and 77% women. Most participants (52%) described their cervical dystonia as mild to moderate with an average pain score of 5/10. Eighty-two (64%) participants were having regular BoNT injections, with overall positive perceived effects. Common activities reported to improve the symptoms were the use of heat packs, massage, relaxation, physiotherapy and participation in general exercise. Common coping strategies reported were getting sufficient rest, having the support of friends and family, and remaining engaged in enjoyable hobbies. We found that most participants received regular BoNT injections and that heat packs, exercise, massage, physiotherapy and relaxation were mostly perceived as effective in reducing the symptoms of cervical dystonia.


Subject(s)
Botulinum Toxins, Type A , Dystonic Disorders , Neuromuscular Agents , Torticollis , Humans , Female , Middle Aged , Adolescent , Male , Torticollis/drug therapy , Botulinum Toxins, Type A/therapeutic use , Conservative Treatment , Dystonic Disorders/drug therapy , Neurotoxins , Neck Muscles , Neuromuscular Agents/therapeutic use , Treatment Outcome
15.
Gynecol Oncol ; 181: 28-32, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38104526

ABSTRACT

BACKGROUND: Malignant ovarian germ cell tumors usually occur in young women. The standard of care is fertility sparing surgery and comprehensive surgical staging followed by adjuvant chemotherapy with BEP (bleomycin, etoposide, cisplatin) if needed. The aim of this study was to analyze the reproductive outcomes after conservative treatment in patients diagnosed, treated and followed up in MITO (Multicenter Italian Trials in Ovarian Cancer) centers. METHODS: A questionnaire concerning gynecological symptoms, reproductive outcomes and fertility treatment was administered to 164 MOGCTs survivors. Data regarding patients deceased were collected from MITO-9 database. There were 114 patients diagnosed at reproductive age between 1983 and 2019 included. RESULTS: 109 patients answered the questionnaire and 5 patients decesased were included (median age 24.9 years). 78.1% were stage I,4.4% stage II, 14.9% stage III and 2.6% stage IV. 57.9% received chemotherapy, the mean number of cycles was 4.1. Median time to menstrual recovery after BEP was of 5.6 months range, only 1 case of premature ovarian failure was reported. Among the 114 patients 38 (33.3%) attempted to become pregnant, 29/38 (76.3%) got pregnant with a total of 44 conceptions. 40.9% received chemotherapy and 22.9% did not (p 0.048). Pregnancy desire was the only predictive factor associated with live births among women who attempted pregnancy after treatment. CONCLUSIONS: As MOGCTs affect women of child-bearing age, fertility preservation represents a major treatment issue. Our results are consistent with the available evidence, confirming that adjuvant chemotherapy for MOGCT does not impact the reproductive function and fertility.


Subject(s)
Neoplasms, Germ Cell and Embryonal , Ovarian Neoplasms , Pregnancy , Female , Humans , Young Adult , Adult , Conservative Treatment , Neoplasm Staging , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/pathology , Reproduction , Cisplatin , Neoplasms, Germ Cell and Embryonal/pathology , Chemotherapy, Adjuvant , Retrospective Studies
16.
BJU Int ; 133(6): 680-689, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38469686

ABSTRACT

BACKGROUND: Older men (aged ≥75 years) with high risk, non-metastatic prostate cancer (PCa) are increasingly treated with curative therapy (surgery or radiotherapy). However, it is unclear if curative therapy prolongs life and improves health-related quality of life (HRQoL) in this age group compared to conservative therapy, which has evolved considerably during the last decade. STUDY DESIGN: The Scandinavian Prostate Cancer Group (SPCG) 19/Norwegian Get-Randomized Research Group-Prostate (GRand-P) is a randomised, two-armed, controlled, multicentre, phase III trial carried out at study centres in Norway, Denmark, Finland, and Sweden. ENDPOINTS: The primary endpoints are overall survival and HRQoL (burden of disease scale, European Organisation for the Research and Treatment of Cancer [EORTC] Elderly Cancer patients). Secondary endpoints are PCa-specific survival, metastasis-free survival, role-functioning scale (EORTC quality of life questionnaire 30-item core), urinary irritative/obstructive scale (26-item Expanded Prostate Cancer Index Composite [EPIC-26]), bowel scale (EPIC-26), intervention-free survival, PCa morbidity, use of secondary and tertiary systemic therapies, mean quality-adjusted life-years (QALYs), and mean total healthcare costs. PATIENTS AND METHODS: A total of 980 men (aged ≥75 years) with non-metastatic, high-risk PCa will initially be screened with Geriatric 8 (G8) health status screening tool and Mini-COG© brief cognitive test. Participants identified by G8 as 'fit' or 'frail' will be randomised (ratio 1:1) to either immediate curative therapy (radiotherapy or prostatectomy) or conservative therapy (endocrine therapy or observation). Participants who are unable or unwilling to participate in randomisation will be enrolled in a separate observation group. Randomised patients will be followed for 10 years. TRIAL REGISTRATION: Ethics approval has been granted in Norway (457593), Denmark (H-22051998), Finland (R23043) and Sweden (Dnr 2023-05296-01). The trial is registered on Clinicaltrials.org (NCT05448547).


Subject(s)
Conservative Treatment , Prostatic Neoplasms , Quality of Life , Aged , Aged, 80 and over , Humans , Male , Clinical Trials, Phase III as Topic , Prostatectomy , Prostatic Neoplasms/therapy , Prostatic Neoplasms/pathology , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
17.
World J Urol ; 42(1): 317, 2024 May 13.
Article in English | MEDLINE | ID: mdl-38740620

ABSTRACT

PURPOSE: To review the literature on the topic, to suggest a common line of treatment applicable across a wide community of specialists, and to contribute in maintaining the high level of interest in this disease. METHODS: A comprehensive and exhaustive review of the literature was performed, identifying hundreds of articles on the topic. RESULTS: Peyronie's disease is a condition that has been recognized, studied, and treated for centuries; despite this, if one excludes surgery in cases in which the deformity is stable, no clear treatment (or line of treatment) is available for complete relief of signs and symptoms. Treatment options were divided into local, oral, and injection therapy, and a wide variety of drugs, remedies, and options were identified. CONCLUSIONS: Low-intensity extracorporeal shock wave therapy, vacuum therapy, penile traction therapy, phosphodiesterase type 5 inhibitors, hyaluronic acid, and collagenase of Clostridium histolyticum may be recommended only in specific contexts. Further studies on individual options or potential combinations are required.


Subject(s)
Conservative Treatment , Penile Induration , Penile Induration/therapy , Humans , Male , Conservative Treatment/methods , Extracorporeal Shockwave Therapy/methods , Phosphodiesterase 5 Inhibitors/therapeutic use , Traction/methods , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/therapeutic use , Microbial Collagenase/therapeutic use , Microbial Collagenase/administration & dosage , Practice Guidelines as Topic
18.
J Surg Res ; 298: 307-315, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38640616

ABSTRACT

INTRODUCTION: Nonoperative management (NOM) of uncomplicated appendicitis (UA) has been increasingly utilized in recent years. The aim of this study was to describe nationwide trends of sociodemographic characteristics, outcomes, and costs of patients undergoing medical versus surgical management for UA. METHODS: The 2018-2019 National (Nationwide) Inpatient Sample was queried for adults (age ≥18 y) with UA; diagnosis, as well as laparoscopic and open appendectomy, were defined by the International Classification of Diseases, 10th Revision, Clinical Modification codes. We examined several characteristics, including cost of care and length of hospital stay. RESULTS: Among the 167,125 patients with UA, 137,644 (82.4%) underwent operative management and 29,481 (17.6%) underwent NOM. In bivariate analysis, we found that patients who had NOM were older (53 versus 43 y, P < 0.001) and more likely to have Medicare (33.6% versus 16.1%, P < 0.001), with higher prevalence of comorbidities such as diabetes (7.8% versus 5.5%, P < 0.001). The majority of NOM patients were treated at urban teaching hospitals (74.5% versus 66.3%, P < 0.001). They had longer LOS's (5.4 versus 2.3 d, P < 0.001) with higher inpatient costs ($15,584 versus $11,559, P < 0.001) than those who had an appendectomy. Through logistic regression we found that older patients had up to 4.03-times greater odds of undergoing NOM (95% CI: 3.22-5.05, P < 0.001). CONCLUSIONS: NOM of UA is more commonly utilized in patients with comorbidities, older age, and those treated in teaching hospitals. This may, however, come at the price of longer length of stay and higher costs. Further guidelines need to be developed to clearly delineate which patients could benefit from NOM.


Subject(s)
Appendectomy , Appendicitis , Length of Stay , Humans , Appendicitis/surgery , Appendicitis/economics , Appendicitis/therapy , Appendicitis/epidemiology , Adult , Male , Female , Middle Aged , Appendectomy/economics , Appendectomy/statistics & numerical data , United States/epidemiology , Length of Stay/statistics & numerical data , Length of Stay/economics , Aged , Young Adult , Adolescent , Laparoscopy/economics , Laparoscopy/statistics & numerical data , Retrospective Studies , Conservative Treatment/economics , Conservative Treatment/statistics & numerical data , Hospital Costs/statistics & numerical data
19.
Scand J Gastroenterol ; 59(7): 770-780, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38613245

ABSTRACT

BACKGROUND: Recurrences or persistent symptoms after an initial episode of diverticulitis are common, yet surgical treatment is rarely performed. Current guidelines lack clear recommendations on whether or not to operate, even though recent studies suggest an improved quality of life following surgery. The aim of this study is therefore to compare quality of life in patients with recurrent or ongoing diverticulitis treated conservatively versus surgically, giving a more definitive answer to the question of whether or not to operate on these patients. METHODS: A systematic literature search was conducted in EMBASE, MEDLINE and Cochrane. Only comparative studies reporting on quality of life were included. Statistical analysis included calculation of weighted mean differences and pooled odds ratios. RESULTS: Five studies were included; two RCT's and three retrospective observational studies. Compared to conservative treatment, the SF-36 scores were higher in the surgically treated group at each follow-up moment but only the difference in SF-36 physical scores at six months follow-up was statistically significant (MD 6.02, 95%CI 2.62-9.42). GIQLI scores were also higher in the surgical group with a MD of 14.01 (95%CI 8.15-19.87) at six months follow-up and 7.42 (95%CI 1.23-12.85) at last available follow-up. Also, at last available follow-up, significantly fewer recurrences occurred in the surgery group (OR 0.10, 95%CI 0.05-0.23, p < 0.001). CONCLUSION: Although surgery for recurrent diverticulitis is not without risk, it might improve long-term quality of life in patients suffering from recurrent- or ongoing diverticulitis when compared to conservative treatment. Therefore, it should be considered in this patient group.


Subject(s)
Quality of Life , Recurrence , Humans , Conservative Treatment , Diverticulitis/surgery , Diverticulitis, Colonic/surgery , Treatment Outcome , Randomized Controlled Trials as Topic
20.
Vasc Med ; 29(3): 274-285, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38334057

ABSTRACT

BACKGROUND: False lumen changes (FLCs) are the main reference for the prognosis judgment and treatment plan selection for type IIa superior mesenteric artery dissection (SMAD). METHODS: For this retrospective study, 55 patients with symptomatic type IIa SMAD were included. Computational fluid dynamics (CFD) analysis was used to explore the hemodynamic basis of FLCs. Correlation and multiple linear regression analyses were performed to identify clinical, morphological and hemodynamic factors associated with FLCs. RESULTS: The FLCs of patients with successful conservative treatment (n = 29) are significantly higher than those with failed conservative treatment (n = 26) (58.5 ± 21.1% vs 10.9 ± 17.4%, p < 0.0001). Positive correlations were seen between FLCs and the morphological parameters false lumen length (FLL)/dissection entrance length (DEL) and FLL. In terms of hemodynamic parameters, negative correlations were seen between FLCs and time-averaged wall shear stress (TAWSS), vorticity, and high areas of TAWSS and vorticity, whereas positive correlations were seen between FLCs and oscillatory shear index (OSI), relative residence time (RRT), and high areas of OSI and RRT. Multiple linear regression analysis identified symptom duration (odds ratio [OR], 0.93; 95% CI, 0.91-0.96; p < 0.0001), FLL/DEL (OR, 1.30; 95% CI, 1.01-1.67; p = 0.044), and high RRT area (OR, 2.03; 95% CI, 1.48-2.78; p < 0.0001) as predictors of FLCs. CONCLUSION: The clinical predictor symptom duration, morphological factor FLL/DEL, and the hemodynamic factor high RRT area can serve as predictors of FLCs in patients with symptomatic type IIa SMAD.


Subject(s)
Aortic Dissection , Hemodynamics , Mesenteric Artery, Superior , Humans , Male , Female , Retrospective Studies , Middle Aged , Mesenteric Artery, Superior/diagnostic imaging , Mesenteric Artery, Superior/physiopathology , Aortic Dissection/physiopathology , Aortic Dissection/diagnostic imaging , Aortic Dissection/therapy , Adult , Risk Factors , Treatment Outcome , Aged , Conservative Treatment , Models, Cardiovascular , Computed Tomography Angiography , Patient-Specific Modeling , Predictive Value of Tests , Splanchnic Circulation
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