-
The Cochrane Database of Systematic... Jan 2013Any form of screening aims to reduce disease-specific and overall mortality, and to improve a person's future quality of life. Screening for prostate cancer has... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Any form of screening aims to reduce disease-specific and overall mortality, and to improve a person's future quality of life. Screening for prostate cancer has generated considerable debate within the medical and broader community, as demonstrated by the varying recommendations made by medical organizations and governed by national policies. To better inform individual patient decision-making and health policy decisions, we need to consider the entire body of data from randomised controlled trials (RCTs) on prostate cancer screening summarised in a systematic review. In 2006, our Cochrane review identified insufficient evidence to either support or refute the use of routine mass, selective, or opportunistic screening for prostate cancer. An update of the review in 2010 included three additional trials. Meta-analysis of the five studies included in the 2010 review concluded that screening did not significantly reduce prostate cancer-specific mortality. In the past two years, several updates to studies included in the 2010 review have been published thereby providing the rationale for this update of the 2010 systematic review.
OBJECTIVES
To determine whether screening for prostate cancer reduces prostate cancer-specific mortality or all-cause mortality and to assess its impact on quality of life and adverse events.
SEARCH METHODS
An updated search of electronic databases (PROSTATE register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CANCERLIT, and the NHS EED) was performed, in addition to handsearching of specific journals and bibliographies, in an effort to identify both published and unpublished trials.
SELECTION CRITERIA
All RCTs of screening versus no screening for prostate cancer were eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS
The original search (2006) identified 99 potentially relevant articles that were selected for full-text review. From these citations, two RCTs were identified as meeting the inclusion criteria. The search for the 2010 version of the review identified a further 106 potentially relevant articles, from which three new RCTs were included in the review. A total of 31 articles were retrieved for full-text examination based on the updated search in 2012. Updated data on three studies were included in this review. Data from the trials were independently extracted by two authors.
MAIN RESULTS
Five RCTs with a total of 341,342 participants were included in this review. All involved prostate-specific antigen (PSA) testing, with or without digital rectal examination (DRE), though the interval and threshold for further evaluation varied across trials. The age of participants ranged from 45 to 80 years and duration of follow-up from 7 to 20 years. Our meta-analysis of the five included studies indicated no statistically significant difference in prostate cancer-specific mortality between men randomised to the screening and control groups (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.86 to 1.17). The methodological quality of three of the studies was assessed as posing a high risk of bias. The European Randomized Study of Screening for Prostate Cancer (ERSPC) and the US Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial were assessed as posing a low risk of bias, but provided contradicting results. The ERSPC study reported a significant reduction in prostate cancer-specific mortality (RR 0.84, 95% CI 0.73 to 0.95), whilst the PLCO study concluded no significant benefit (RR 1.15, 95% CI 0.86 to 1.54). The ERSPC was the only study of the five included in this review that reported a significant reduction in prostate cancer-specific mortality, in a pre-specified subgroup of men aged 55 to 69 years of age. Sensitivity analysis for overall risk of bias indicated no significant difference in prostate cancer-specific mortality when referring to the meta analysis of only the ERSPC and PLCO trial data (RR 0.96, 95% CI 0.70 to 1.30). Subgroup analyses indicated that prostate cancer-specific mortality was not affected by the age at which participants were screened. Meta-analysis of four studies investigating all-cause mortality did not determine any significant differences between men randomised to screening or control (RR 1.00, 95% CI 0.96 to 1.03). A diagnosis of prostate cancer was significantly greater in men randomised to screening compared to those randomised to control (RR 1.30, 95% CI 1.02 to 1.65). Localised prostate cancer was more commonly diagnosed in men randomised to screening (RR 1.79, 95% CI 1.19 to 2.70), whilst the proportion of men diagnosed with advanced prostate cancer was significantly lower in the screening group compared to the men serving as controls (RR 0.80, 95% CI 0.73 to 0.87). Screening resulted in a range of harms that can be considered minor to major in severity and duration. Common minor harms from screening include bleeding, bruising and short-term anxiety. Common major harms include overdiagnosis and overtreatment, including infection, blood loss requiring transfusion, pneumonia, erectile dysfunction, and incontinence. Harms of screening included false-positive results for the PSA test and overdiagnosis (up to 50% in the ERSPC study). Adverse events associated with transrectal ultrasound (TRUS)-guided biopsies included infection, bleeding and pain. No deaths were attributed to any biopsy procedure. None of the studies provided detailed assessment of the effect of screening on quality of life or provided a comprehensive assessment of resource utilization associated with screening (although preliminary analyses were reported).
AUTHORS' CONCLUSIONS
Prostate cancer screening did not significantly decrease prostate cancer-specific mortality in a combined meta-analysis of five RCTs. Only one study (ERSPC) reported a 21% significant reduction of prostate cancer-specific mortality in a pre-specified subgroup of men aged 55 to 69 years. Pooled data currently demonstrates no significant reduction in prostate cancer-specific and overall mortality. Harms associated with PSA-based screening and subsequent diagnostic evaluations are frequent, and moderate in severity. Overdiagnosis and overtreatment are common and are associated with treatment-related harms. Men should be informed of this and the demonstrated adverse effects when they are deciding whether or not to undertake screening for prostate cancer. Any reduction in prostate cancer-specific mortality may take up to 10 years to accrue; therefore, men who have a life expectancy less than 10 to 15 years should be informed that screening for prostate cancer is unlikely to be beneficial. No studies examined the independent role of screening by DRE.
Topics: Aged; Aged, 80 and over; Biopsy, Fine-Needle; Digital Rectal Examination; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Humans; Male; Mass Screening; Middle Aged; Prostate; Prostate-Specific Antigen; Prostatic Neoplasms; Randomized Controlled Trials as Topic
PubMed: 23440794
DOI: 10.1002/14651858.CD004720.pub3 -
Diagnostics (Basel, Switzerland) Mar 2023(1) Background: Among new anti-angiogenesis agents being developed and ever-changing guidelines indications, the question of the benefits/safety ratio remains unclear.... (Review)
Review
(1) Background: Among new anti-angiogenesis agents being developed and ever-changing guidelines indications, the question of the benefits/safety ratio remains unclear. (2) Methods: We performed a systematic review combined with a meta-analysis of 23 randomized controlled trials (12,081 patients), evaluating overall survival (OS), progression free survival (PFS) and toxicity (grade ≥ 3 toxic effects, type, and number of all adverse effects. (3) Results: The analysis showed improvement of pooled-PFS (HR, 0.71; 95% CI, 0.64-0.78; I = 77%; < 0.00001) in first-line (HR, 0.85; 95% CI, 0.78-0.93; = 0.0003) or recurrent cancer (HR, 0.62; 95% CI, 0.56-0.70; < 0.00001) and regardless of the type of anti-angiogenesis drug used (Vascular endothelial growth factor (VEGF) inhibitors, VEGF-receptors (VEGF-R) inhibitors or angiopoietin inhibitors). Improved OS was also observed (HR, 0.95; 95% CI, 0.90-0.99; = 0.03). OS benefits were only observed in recurrent neoplasms, both platinum-sensitive and platinum-resistant neoplasms. Grade ≥ 3 adverse effects were increased across all trials. Anti-angiogenetic therapy increased the risk of hypertension, infection, thromboembolic/hemorrhagic events, and gastro-intestinal perforations but not the risk of wound-related issues, anemia or posterior leukoencephalopathy syndrome. (4) Conclusions: Although angiogenesis inhibitors improve PFS, there are little-to-no OS benefits. Given the high risk of severe adverse reactions, a careful selection of patients is required for obtaining the best results possible.
PubMed: 36980348
DOI: 10.3390/diagnostics13061040 -
The Cochrane Database of Systematic... Oct 2022Premature ovarian insufficiency (POI) is a clinical syndrome resulting from loss of ovarian function before the age of 40. It is a state of hypergonadotropic... (Review)
Review
BACKGROUND
Premature ovarian insufficiency (POI) is a clinical syndrome resulting from loss of ovarian function before the age of 40. It is a state of hypergonadotropic hypogonadism, characterised by amenorrhoea or oligomenorrhoea, with low ovarian sex hormones (oestrogen deficiency) and elevated pituitary gonadotrophins. POI with primary amenorrhoea may occur as a result of chromosomal and genetic abnormalities, such as Turner syndrome, Fragile X, or autosomal gene defects; secondary amenorrhoea may be iatrogenic after the surgical removal of the ovaries, radiotherapy, or chemotherapy. Other causes include autoimmune diseases, viral infections, and environmental factors; in most cases, POI is idiopathic. Appropriate replacement of sex hormones in women with POI may facilitate the achievement of near normal uterine development. However, the optimal effective hormone therapy (HT) regimen to maximise the reproductive potential for women with POI remains unclear.
OBJECTIVES
To investigate the effectiveness and safety of different hormonal regimens on uterine and endometrial development in women with POI.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in September 2021. We also checked references of included studies, and contacted study authors to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) investigating the effect of various hormonal preparations on the uterine development of women diagnosed with POI.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. The primary review outcome was uterine volume; secondary outcomes were endometrial thickness, endometrial histology, uterine perfusion, reproductive outcomes, and any reported adverse events.
MAIN RESULTS
We included three studies (52 participants analysed in total) investigating the role of various hormonal preparations in three different contexts, which deemed meta-analysis unfeasible. We found very low-certainty evidence; the main limitation was very serious imprecision due to small sample size. Conjugated oral oestrogens versus transdermal 17ß-oestradiol We are uncertain of the effect of conjugated oral oestrogens compared to transdermal 17ß-oestradiol (mean difference (MD) -18.2 (mL), 95% confidence interval (CI) -23.18 to -13.22; 1 RCT, N = 12; very low-certainty evidence) on uterine volume, measured after 12 months of treatment. The study reported no other relevant outcomes (including adverse events). Low versus high 17ß-oestradiol dose We are uncertain of the effect of a lower dose of 17ß-oestradiol compared to a higher dose of 17ß-oestradiol on uterine volume after three or five years of treatment, or adverse events (1 RCT, N = 20; very low-certainty evidence). The study reported no other relevant outcomes. Oral versus vaginal administration of oestradiol and dydrogesterone We are uncertain of the effect of an oral or vaginal administration route on uterine volume and endometrial thickness after 14 or 21 days of administration (1 RCT, N = 20; very low-certainty evidence). The study reported no other relevant outcomes (including adverse events).
AUTHORS' CONCLUSIONS
No clear conclusions can be drawn in this systematic review, due to the very low-certainty of the evidence. There is a need for pragmatic, well designed, randomised controlled trials, with adequate power to detect differences between various HT regimens on uterine growth, endometrial development, and pregnancy outcomes following the transfer of donated gametes or embryos in women diagnosed with POI.
Topics: Amenorrhea; Dydrogesterone; Endometrium; Estradiol; Estrogens; Female; Humans; Menopause, Premature; Pregnancy
PubMed: 36200708
DOI: 10.1002/14651858.CD008209.pub2 -
Romanian Journal of Morphology and... 2019Primary ovarian hydatid disease (HD) is a rare entity, produced by the larval stage of Echinococcus granulosus. HD commonly involves liver, lung, abdomen cavity, spleen...
Primary ovarian hydatid disease (HD) is a rare entity, produced by the larval stage of Echinococcus granulosus. HD commonly involves liver, lung, abdomen cavity, spleen and is unusually identified in pelvic organs. Based on our knowledge, the paper reviews 27 literature reports of ovarian HD, diagnosed during the last 20 years, providing a valuable database. Patients' ages ranged between 12-76 years, the gross appearance was that of 40-330 mm diameter hydatid cysts (HCs), 66.66% of them being primary. According to these reports, ovarian HD has non-specific clinical manifestations, such as abdominal or pelvic pain, nausea, dysmenorrhea or amenorrhea. The diagnosis may be achieved by abdominal ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI), serological exams, such as eosinophilia (in 10-30% of patients) or indirect hemagglutination and immunoglobulin (IgG) antibodies detection. Ovarian HC microscopic pattern is characterized by three layers: pericyst or adventitia (host origin), germinal layer (endocyst), and laminated membrane (ectocyst). The immunoreaction triggered by parasites is initially rich in macrophages and neutrophils, followed by eosinophils and lymphocytes, with numerous cluster of differentiation 8 (CD8)-positive T-cells in active lesions and progressive forms. Concomitant ovarian diseases are relatively rare, being represented by borderline tumors (n=2 cases), mucinous cystadenoma (n=1 case), hemorrhagic cyst (n=1 case), and serous adenocarcinoma (n=1 case). In conclusion, the ovarian location of HD should be considered in any differential diagnosis of a cystic lesion, while it does not exclude synchronous ovarian tumors. These cases reinforce the necessity of better measures of prophylaxis and screening of HD in endemic areas.
Topics: Adolescent; Adult; Aged; Child; Echinococcosis; Female; Humans; Immunohistochemistry; Middle Aged; Ovarian Cysts; Young Adult
PubMed: 31912083
DOI: No ID Found -
The Cochrane Database of Systematic... Jan 2016Ovarian cancer tends to be chemosensitive and confine itself to the surface of the peritoneal cavity for much of its natural history. These features have made it an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Ovarian cancer tends to be chemosensitive and confine itself to the surface of the peritoneal cavity for much of its natural history. These features have made it an obvious target for intraperitoneal (IP) chemotherapy. Chemotherapy for ovarian cancer is usually given as an intravenous (IV) infusion repeatedly over five to eight cycles. Intraperitoneal chemotherapy is given by infusion of the chemotherapeutic agent directly into the peritoneal cavity. There are biological reasons why this might increase the anticancer effect and reduce some systemic adverse effects in comparison to IV therapy.
OBJECTIVES
To determine if adding a component of the chemotherapy regime into the peritoneal cavity affects overall survival, progression-free survival, quality of life (QOL) and toxicity in the primary treatment of epithelial ovarian cancer.
SEARCH METHODS
We searched the Gynaecological Cancer Review Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2011, MEDLINE (1951 to May 2011) and EMBASE (1974 to May 2011). We updated these searches in February 2007, August 2010, May 2011 and September 2015. In addition, we handsearched and cascade searched the major gynaecological oncology journals up to May 2011.
SELECTION CRITERIA
The analysis was restricted to randomised controlled trials (RCTs) assessing women with a new diagnosis of primary epithelial ovarian cancer, of any FIGO stage, following primary cytoreductive surgery. Standard IV chemotherapy was compared with chemotherapy that included a component of IP administration.
DATA COLLECTION AND ANALYSIS
We extracted data on overall survival, disease-free survival, adverse events and QOL and performed meta-analyses of hazard ratios (HR) for time-to-event variables and relative risks (RR) for dichotomous outcomes using RevMan software.
MAIN RESULTS
Nine randomised trials studied 2119 women receiving primary treatment for ovarian cancer. We considered six trials to be of high quality. Women were less likely to die if they received an IP component to chemotherapy (eight studies, 2026 women; HR = 0.81; 95% confidence interval (CI): 0.72 to 0.90). Intraperitoneal component chemotherapy prolonged the disease-free interval (five studies, 1311 women; HR = 0.78; 95% CI: 0.70 to 0.86). There was greater serious toxicity with regard to gastrointestinal effects, pain, fever and infection but less ototoxicity with the IP than the IV route.
AUTHORS' CONCLUSIONS
Intraperitoneal chemotherapy increases overall survival and progression-free survival from advanced ovarian cancer. The results of this meta-analysis provide the most reliable estimates of the relative survival benefits of IP over IV therapy and should be used as part of the decision making process. However, the potential for catheter related complications and toxicity needs to be considered when deciding on the most appropriate treatment for each individual woman. The optimal dose, timing and mechanism of administration cannot be addressed from this meta-analysis. This needs to be addressed in the next phase of clinical trials.
Topics: Antineoplastic Agents; Disease-Free Survival; Female; Humans; Induction Chemotherapy; Infusions, Intravenous; Infusions, Parenteral; Ovarian Neoplasms; Randomized Controlled Trials as Topic
PubMed: 26755441
DOI: 10.1002/14651858.CD005340.pub4 -
Frontiers in Oncology 2022The impact of obesity on the surgical outcomes in patients after primary ovarian cancer surgery is unclear. We aimed at conducting a meta-analysis to evaluate the...
BACKGROUND
The impact of obesity on the surgical outcomes in patients after primary ovarian cancer surgery is unclear. We aimed at conducting a meta-analysis to evaluate the associations between obesity and major surgical outcomes in ovarian cancer patients.
METHOD
Embase, PubMed and Web of Science databases were searched for eligible studies. Study-specific relative risks (RR) were pooled using fixed effect model when little evidence of heterogeneity was detected, otherwise random effect model was employed.
RESULTS
Twelve eligible studies were identified. The pooled incidence rates of all complications were 38% (95% CI: 29%, 47%) for obese patients and 27% (95% CI: 18%, 36%) for non-obese patients. Compared with the non-obese patients, there was a significantly increased risk of all complications in obese patients after ovarian cancer surgery, with a pooled RR of 1.75 (95% CI: 1.26, 2.43). For advanced (stages III-IV) ovarian cancer, the pooled RR of all complications was 1.55 (95% CI: 1.07, 2.24). Obese patients after ovarian cancer surgery were at higher risks of wound complication (pooled RR: 7.06, 95% CI: 3.23, 15.40) and infection (pooled RR: 1.94, 95% CI: 1.47, 2.55) compared with non-obese patients. Such increased risk was not observed for other major complications, namely, venous thromboembolism, ileus and organ failure. Hospital stay days between obese patients and non-obese patients were similar (Standardized Mean Difference: -0.28, 95% CI: -0.75, 0.19). The rates of optimal debulking (pooled RR: 0.96, 95% CI: 0.90, 1.03), readmission/return to operation room (pooled RR: 1.20, 95% CI: 0.56, 2.57) and 30-day mortality (pooled RR: 0.95, 95% CI: 0.54, 1.66) were also comparable between obese patients and non-obese patients.
CONCLUSION
Obesity is associated with an increased risk of postoperative complications, especially wound complications and infection after primary ovarian cancer surgery. Obesity may not affect their optimal debulking rates and 30-day mortality in patients undergoing ovarian cancer surgery. Besides, to improve surgical outcomes, an advanced minimally invasive robotic approach seems to be feasible for the treatment of obese patients with ovarian cancer.
PubMed: 35223523
DOI: 10.3389/fonc.2022.841306 -
The Cochrane Database of Systematic... Aug 2018People with advanced ovarian or gastrointestinal cancer may develop malignant bowel obstruction (MBO). They are able to tolerate limited, if any, oral or enteral (via a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People with advanced ovarian or gastrointestinal cancer may develop malignant bowel obstruction (MBO). They are able to tolerate limited, if any, oral or enteral (via a tube directly into the gut) nutrition. Parenteral nutrition (PN) is the provision of macronutrients, micronutrients, electrolytes and fluid infused as an intravenous solution and provides a method for these people to receive nutrients. There are clinical and ethical arguments for and against the administration of PN to people receiving palliative care.
OBJECTIVES
To assess the effectiveness of home parenteral nutrition (HPN) in improving survival and quality of life in people with inoperable MBO.
SEARCH METHODS
We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), MEDLINE (Ovid), Embase (Ovid), BNI, CINAHL, Web of Science and NHS Economic Evaluation and Health Technology Assessment up to January 2018, ClinicalTrials.gov (http://clinicaltrials.gov/) and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal (http://apps.who.int/trialsearch/). In addition, we handsearched included studies and used the 'Similar articles' feature on PubMed for included articles.
SELECTION CRITERIA
We included any studies with more than five participants investigating HPN in people over 16 years of age with inoperable MBO.
DATA COLLECTION AND ANALYSIS
We extracted the data and assessed risk of bias for each study. We entered data into Review Manager 5 and used GRADEpro to assess the quality of the evidence.
MAIN RESULTS
We included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary.The evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN.
AUTHORS' CONCLUSIONS
We are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.
Topics: Abdominal Neoplasms; Adult; Aged; Female; Humans; Intestinal Obstruction; Male; Middle Aged; Observational Studies as Topic; Parenteral Nutrition, Home; Quality of Life
PubMed: 30095168
DOI: 10.1002/14651858.CD012812.pub2 -
Immunity, Inflammation and Disease Jan 2024The current study aims to evaluate the impact of COVID-19 infection and vaccination on ovarian reserve by detecting the anti-Mullerian hormone (AMH) level. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The current study aims to evaluate the impact of COVID-19 infection and vaccination on ovarian reserve by detecting the anti-Mullerian hormone (AMH) level.
METHOD
PubMed, Embase, Web of Science, and Scopus has been searched for studies assessing the effect of COVID-19 infection and/or vaccination on AMH levels up to February 27, 2023. Based on PRISMA 2020 statement criteria, a systematic review and meta-analysis of included studies were performed. The studies' quality was assessed by the National Institute of Health (NIH) quality assessment tool. The standardized mean difference (MD) of the AMH level was used and the quantitative values of each study were pooled separately by using a random effect model.
RESULTS
Out of 246 studies screened, 18 were included in the systematic review and 14 in the meta-analysis. Included studies were published between 2021 and 2022 and were conducted in different countries, including the USA (n = 3), China (n = 2), Russia (n = 2), Turkey (n = 5), Israel (n = 3), Czech (n = 2), and Spain (n = 1). Eight studies investigated the effect of SARS-CoV-2 infection on AMH levels, and ten studies investigated the possible effect of COVID-19 vaccination on AMH levels. The pooled analysis showed a statistically significant decrease in AMH levels after COVID-19 infection (SMD: -0.24; 95% CI: -0.36 to -0.11; I2 = 0%; p = .0003). Vaccination analysis showed a nonstatistically significant change in AMH levels after COVID-19 vaccination (SMD: -0.11; 95% CI: -0.25 to 0.04; I2 = 35%; p = .14).
CONCLUSION
COVID-19 infection can result in ovarian reserve injury by reducing the AMH level but getting vaccinated against COVID-19 has no impact on the AMH level.
Topics: Humans; Anti-Mullerian Hormone; COVID-19; COVID-19 Vaccines; SARS-CoV-2; Vaccination; Transforming Growth Factor beta
PubMed: 38270314
DOI: 10.1002/iid3.1136 -
BMJ Open Feb 2020We aimed to evaluate the safety, efficiency and preferred indication for laparoendoscopic single-site surgery (LESS) compared with conventional laparoscopic (CL) surgery... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
We aimed to evaluate the safety, efficiency and preferred indication for laparoendoscopic single-site surgery (LESS) compared with conventional laparoscopic (CL) surgery for benign ovarian masses.
DESIGN
A systemic review and cumulative meta-analysis were performed in line with the criteria of Grading of Recommendations Assessment, Development and Evaluation: levels of evidence and grades of recommendation.
DATA SOURCES
We comprehensively searched the electronic databases including PubMed, Medline, Embase and the Cochrane Library in November 2018.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
We included all randomised controlled trials (RCTs) and retrospective studies published in recent 10 years, which investigated the performance of LESS versus CL in patients at all ages with benign ovarian masses.
RESULTS
Four RCTs and nine retrospective studies published in recent decade including 1542 cases (744 cases for LESS and 798 cases for CL) were identified. Perioperative complication was consisted of intraoperative and postoperative complications, including ileus, wound infection or dehiscence and incisional hernia. Although LESS has less postoperative analgesic consumption (46.78% and 79.25%; OR: 0.49; 95% CI: 0.33 to 0.74, p<0.001) and shorter hospital stay (weighted mean difference (WMD): -0.24 days; 95% CI: -0.35 to -0.14; p<0.001), CL has less perioperative complications (6.59% and 2.85%; OR: 2.08; 95% CI: 1.05 to 4.11, p=0.04) and shorter operative time (WMD: 3.43 min; 95% CI: -0.03 to 6.88; p=0.05). Body mass index, history of previous abdominal surgery, size of adnexal mass, estimated blood loss and postoperative pain scores did not differ significantly between two techniques.
CONCLUSIONS
The indications of LESS for benign ovarian masses are similar to CL and it has better postoperative recovery. However, with less perioperative complications, CL surgery is safer than LESS.
Topics: Endoscopy; Female; Humans; Laparoscopy; Operative Time; Ovarian Neoplasms; Ovary; Postoperative Complications; Treatment Outcome
PubMed: 32066600
DOI: 10.1136/bmjopen-2019-032331 -
The Cochrane Database of Systematic... Jul 2015Assisted reproduction techniques (ART), such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), can help subfertile couples to create a family.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Assisted reproduction techniques (ART), such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), can help subfertile couples to create a family. It is necessary to induce multiple follicles, which is achieved by follicle stimulating hormone (FSH) injections. Current treatment regimens prescribe daily injections of FSH (urinary FSH either with or without luteinizing hormone (LH) injections or recombinant FSH (rFSH)).Recombinant DNA technologies have produced a new recombinant molecule which is a long-acting FSH, named corifollitropin alfa (Elonva) or FSH-CTP. A single dose of long-acting FSH is able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week. The optimal dose of long-acting FSH is still being determined. A single injection of long-acting FSH can replace seven daily FSH injections during the first week of controlled ovarian stimulation (COS) and can make assisted reproduction more patient friendly.
OBJECTIVES
To compare the effectiveness of long-acting FSH versus daily FSH in terms of pregnancy and safety outcomes in women undergoing IVF or ICSI treatment cycles.
SEARCH METHODS
We searched the following electronic databases, trial registers and websites from inception to June 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialized Register, MEDLINE, EMBASE, PsycINFO, CINAHL, electronic trial registers for ongoing and registered trials, citation indexes, conference abstracts in the ISI Web of Knowledge, LILACS, Clinical Study Results (for clinical trial results of marketed pharmaceuticals), PubMed and OpenSIGLE. We also carried out handsearches.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) comparing long-acting FSH versus daily FSH in women who were part of a couple with subfertility and undertaking IVF or ICSI treatment cycles with a GnRH antagonist or agonist protocol.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, data extraction and assessment of risk of bias. We contacted trial authors in cases of missing data. We calculated risk ratios for each outcome, and our primary outcomes were live birth rate and ovarian hyperstimulation syndrome (OHSS) rate. Our secondary outcomes were ongoing pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, any other adverse event (including ectopic pregnancy, congenital malformations, drug side effects and infection) and patient satisfaction with the treatment. Trials reported all outcomes, except patient satisfaction with the treatment.
MAIN RESULTS
We included six RCTs with a total of 3753 participants and we graded the quality of the included studies as moderate. All studies included women with an indication for COS as part of an IVF/ICSI cycle with age ranging from 18 to 41 years. A comparison of long-acting FSH versus daily FSH did not show evidence of difference in effect on overall live birth rate (Risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.07; 2363 participants, eight studies; I² statistic = 44%) or OHSS (RR 1.00, 95% CI 0.74 to 1.37; 3753 participants, nine studies; I² statistic = 0%). We compared subgroups by dose of long-acting FSH. There was evidence of reduced live birth rate in women who received lower doses (60 to 120 μg) of long-acting FSH compared to daily FSH (RR 0.70, 95% CI 0.52 to 0.93; 645 participants, three studies; I² statistic = 0%). There was no evidence a difference between the groups in live births in the medium dose (150 to 180 μg) subgroup (RR 1.03, 95% CI 0.90 to 1.18; 1685 participants, four studies; I² statistic = 6%). There was no evidence of a difference between the groups in the clinical pregnancy rate (any dose), ongoing pregnancy rate (any dose), multiple pregnancy rate (any dose), miscarriage rate (low or medium dose), ectopic pregnancy rate (any dose), congenital malformation rate, congenital malformation rate; major or minor (low or medium dose).
AUTHORS' CONCLUSIONS
The use of a medium dose (150 to 180 μg) of long-acting FSH is a safe treatment option and equally effective compared to daily FSH in women with unexplained subfertility. There was evidence of reduced live birth rate in women receiving a low dose (60 to 120 μg) of long-acting FSH compared to daily FSH. Further research is needed to determine whether long-acting FSH is safe and effective for use in hyper- or poor responders and in women with all causes of subfertility.
Topics: Adult; Delayed-Action Preparations; Female; Fertilization in Vitro; Follicle Stimulating Hormone; Follicle Stimulating Hormone, Human; Hormones; Humans; Live Birth; Luteinizing Hormone; Ovulation Induction; Pregnancy; Randomized Controlled Trials as Topic; Recombinant Proteins; Sperm Injections, Intracytoplasmic
PubMed: 26171903
DOI: 10.1002/14651858.CD009577.pub3