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The Cochrane Database of Systematic... Aug 2015The four approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic-assisted... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The four approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic-assisted hysterectomy (RH).
OBJECTIVES
To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions.
SEARCH METHODS
We searched the following databases (from inception to 14 August 2014) using the Ovid platform: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO. We also searched relevant citation lists. We used both indexed and free-text terms.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another.
DATA COLLECTION AND ANALYSIS
At least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction, quality of life, intraoperative visceral injury and major long-term complications (i.e. fistula, pelvi-abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction).
MAIN RESULTS
We included 47 studies with 5102 women. The evidence for most comparisons was of low or moderate quality. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (nine RCTs, 762 women)Return to normal activities was shorter in the VH group (mean difference (MD) -9.5 days, 95% confidence interval (CI) -12.6 to -6.4, three RCTs, 176 women, I(2) = 75%, moderate quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (25 RCTs, 2983 women)Return to normal activities was shorter in the LH group (MD -13.6 days, 95% CI -15.4 to -11.8; six RCTs, 520 women, I(2) = 71%, low quality evidence), but there were more urinary tract injuries in the LH group (odds ratio (OR) 2.4, 95% CI 1.2 to 4.8, 13 RCTs, 2140 women, I(2) = 0%, low quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. LH versus VH (16 RCTs, 1440 women)There was no evidence of a difference between the groups for any primary outcomes. Robotic-assisted hysterectomy (RH) versus LH (two RCTs, 152 women)There was no evidence of a difference between the groups for any primary outcomes. Neither of the studies reported satisfaction rates or quality of life.Overall, the number of adverse events was low in the included studies.
AUTHORS' CONCLUSIONS
Among women undergoing hysterectomy for benign disease, VH appears to be superior to LH and AH, as it is associated with faster return to normal activities. When technically feasible, VH should be performed in preference to AH because of more rapid recovery and fewer febrile episodes postoperatively. Where VH is not possible, LH has some advantages over AH (including more rapid recovery and fewer febrile episodes and wound or abdominal wall infections), but these are offset by a longer operating time. No advantages of LH over VH could be found; LH had a longer operation time, and total laparoscopic hysterectomy (TLH) had more urinary tract injuries. Of the three subcategories of LH, there are more RCT data for laparoscopic-assisted vaginal hysterectomy and LH than for TLH. Single-port laparoscopic hysterectomy and RH should either be abandoned or further evaluated since there is a lack of evidence of any benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed and decided in the light of the relative benefits and hazards. These benefits and hazards seem to be dependent on surgical expertise and this may influence the decision. In conclusion, when VH is not feasible, LH may avoid the need for AH, but LH is associated with more urinary tract injuries. There is no evidence that RH is of benefit in this population. Preferably, the surgical approach to hysterectomy should be decided by the woman in discussion with her surgeon.
Topics: Female; Genital Diseases, Female; Humans; Hysterectomy; Hysterectomy, Vaginal; Laparoscopy; Randomized Controlled Trials as Topic; Recovery of Function; Robotic Surgical Procedures
PubMed: 26264829
DOI: 10.1002/14651858.CD003677.pub5 -
Oncology Reviews Sep 2014Cervical cancer is the second most common cancer in women. Neoadjuvant chemotherapy for patients with locally advanced cervix cancer has comparable benefits to... (Review)
Review
Cervical cancer is the second most common cancer in women. Neoadjuvant chemotherapy for patients with locally advanced cervix cancer has comparable benefits to concurrent chemoradiotherapy (CCRT), but with fewer side effects. This systematic review aims to provide a comprehensive summary of the benefits of neoadjuvant chemotherapy for the management of locally advanced cervix cancer from stage IB2 (tumor >4.0 cm) to IIIB (tumor extending to the pelvic wall and/or hydronephrosis). Our primary objective was to assess benefits in terms of survival. The data source included the USA national library of medicine, Medline search, and the National Cancer Institute PDQ Clinical Protocols. Inclusion criteria for consideration in the current systematic review included studies published between January 1997 and December 2012. In terms of histology, they had to be focused on squamous cell carcinoma, adenosquamous carcinoma, and/or adenocarcinoma. Patients should be either chemotherapy naïve or cervix cancer chemotherapy naïve, and have a performance status ≤2. The search in the above-mentioned scientific websites led to identify 49 publications, 19 of which were excluded, as they did not meet the inclusion criteria of this systematic review. Therefore only 30 studies were deemed eligible. Data was collected from 1760 patients enrolled in the current systematic review study. The mean age was 45.2 years. The mean tumor size was 4.7 cm. The most commonly used chemotherapies were cisplatin doublets. Paclitaxel was the most commonly used chemotherapeutic agent in the doublets. The mean chemotherapy cycles were 2.7. After chemotherapy, patients underwent surgery after a mean time of 2.5 weeks. The standard operation was radical hysterectomy with pelvic lymphadenectomy. Chemotherapy achieved an objective response rate of 84%. The 5-year progression-free survival and overall survival were 61.9% and 72.8% respectively. The treatment protocol was associated with a mild early toxicity profile. Leucopenia and neutropenia were the most common side effects. Late toxicity was also generally mild and mainly associated with bladder dysfunction and vaginal dehiscence. The quality of the studies was assessed using the Newcastle-Ottawa quality assessment scale. Neoadjuvant chemotherapy achieved comparable survival results to CCRT, and was associated with less toxicity.
PubMed: 25992238
DOI: 10.4081/oncol.2014.250 -
Archives of Gynecology and Obstetrics Oct 2015Some studies suggest that also regarding the patient with a body mass index (BMI) ≥35 kg/m(2) the minimally invasive approach to hysterectomy is superior. However,... (Review)
Review
PURPOSE
Some studies suggest that also regarding the patient with a body mass index (BMI) ≥35 kg/m(2) the minimally invasive approach to hysterectomy is superior. However, current practice and research on the preference of gynaecologists still show that the rate of abdominal hysterectomy (AH) increases as the BMI increases. A systematic review with cumulative analysis of comparative studies was performed to evaluate the outcomes of AH, laparoscopic hysterectomy (LH) and vaginal hysterectomy (VH) in very obese and morbidly obese patients (BMI ≥35 kg/m(2)).
METHODS
PubMed and EMBASE were searched for records on AH, LH and VH for benign indications or (early stage) malignancy through October 2014. Included studies were graded on level of evidence. Studies with a comparative design were pooled in a cumulative analysis.
RESULTS
Two randomized controlled trials, seven prospective studies and 14 retrospective studies were included (2232 patients; 1058 AHs, 959 LHs, and 215 VHs). The cumulative analysis identified that, compared to LH, AH was associated with more wound dehiscence [risk ratio (RR) 2.58, 95 % confidence interval (CI) 1.71-3.90; P = 0.000], more wound infection (RR 4.36, 95 % CI 2.79-6.80; P = 0.000), and longer hospital admission (mean difference 2.9 days, 95 % CI 1.96-3.74; P = 0.000). The pooled conversion rate was 10.6 %. Compared to AH, VH was associated with similar advantages as LH.
CONCLUSIONS
Compared to AH, both LH and VH are associated with fewer postoperative complications and shorter length of hospital stay. Therefore, the feasibility of LH and VH should be considered prior the abdominal approach to hysterectomy in very obese and morbidly obese patients.
Topics: Adult; Female; Genital Diseases, Female; Humans; Hysterectomy; Hysterectomy, Vaginal; Laparoscopy; Length of Stay; Middle Aged; Morbidity; Obesity; Obesity, Morbid; Operative Time; Postoperative Complications; Treatment Outcome
PubMed: 25773357
DOI: 10.1007/s00404-015-3680-7 -
The Cochrane Database of Systematic... Dec 2014This is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for... (Review)
Review
BACKGROUND
This is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.
OBJECTIVES
To assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.
SEARCH METHODS
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 5) and the Cochrane Gynaecological Cancer Review Group Trials Register. We also searched MEDLINE and EMBASE databases, to complement the searches of the original malignant and benign disease reviews (conducted up to July 2010 and November 2011, respectively), from July 2010 to June 2014.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of RAS compared with CLS or open surgery in women requiring surgery for gynaecological disease.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We subgrouped data according to type of procedure and pooled data using random-effects methods in RevMan 5.3. We performed sensitivity analyses by excluding studies at high risk of bias.
MAIN RESULTS
We included six RCTs involving 517 women. Most were at low to moderate overall risk of bias; one was at high risk of bias. Four studies evaluated RAS for hysterectomy (371 women), and two studies evaluated RAS for sacrocolpopexy (146 women). All studies compared RAS with CLS, except for one study, which compared RAS with CLS or a vaginal surgical approach for hysterectomy. Confidence intervals for the risk of intraoperative and postoperative complications included benefits with either approach when they were analysed together (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.46 to 1.99; participants = 513; studies = 6; I(2) = 74%) and separately (low-quality evidence). Moderate-quality evidence was found for the effects of RAS on intraoperative injury when compared with CLS (RR 1.23, 95% CI 0.44 to 3.46; participants = 415; studies = 5; I(2) = 0%), along with low-quality evidence for bleeding and infection complications.Mean total operating time was consistent across procedures and on average was about 42 minutes longer in the RAS arm compared with the CLS arm (95% CI 17 to 66 minutes; participants = 294; studies = 4; I(2) = 82%; moderate-quality evidence). Mean hospital stay for hysterectomy procedures was on average about seven hours shorter in the RAS arm than in the CLS arm (mean difference (MD) -0.30 days, 95% CI -0.54 to -0.06; participants = 217; studies = 2; I(2) = 0%; low-quality evidence). The estimated effect of conversion with RAS compared with CLS was imprecise (RR 1.28, 95% CI 0.40 to 4.12; participants = 337; studies = 4; I(2) = 0%; moderate-quality evidence). Limited data from two studies suggest that RAS for sacrocolpopexy may be associated with increased postoperative pain compared with CLS; this needs further investigation. We identified five ongoing trials-four of cancer surgery.
AUTHORS' CONCLUSIONS
We are uncertain as to whether RAS or CLS has lower intraoperative and postoperative complication rates because of the imprecision of the effect and inconsistency among studies when they are used for hysterectomy and sacrocolpopexy. Moderate-quality evidence suggests that these procedures take longer with RAS but may be associated with a shorter hospital stay following hysterectomy. We found limited evidence on the effectiveness and safety of RAS compared with CLS or open surgery for surgical procedures performed for gynaecological cancer; therefore its use should be limited to clinical trials. Ongoing trials are likely to have an important impact on evidence related to the use of RAS in gynaecology.
Topics: Female; Genital Diseases, Female; Gynecologic Surgical Procedures; Humans; Hysterectomy; Laparoscopy; Randomized Controlled Trials as Topic; Robotic Surgical Procedures
PubMed: 25493418
DOI: 10.1002/14651858.CD011422 -
The Cochrane Database of Systematic... Aug 2014Benign smooth muscle tumours of the uterus, known as fibroids or myomas, are often symptomless. However, about one-third of women with fibroids will present with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Benign smooth muscle tumours of the uterus, known as fibroids or myomas, are often symptomless. However, about one-third of women with fibroids will present with symptoms that are severe enough to warrant treatment. The standard treatment of symptomatic fibroids is hysterectomy (that is surgical removal of the uterus) for women who have completed childbearing, and myomectomy for women who desire future childbearing or simply want to preserve their uterus. Myomectomy, the surgical removal of myomas, can be associated with life-threatening bleeding. Excessive bleeding can necessitate emergency blood transfusion. Knowledge of the effectiveness of the interventions to reduce bleeding during myomectomy is essential to enable evidence-based clinical decisions. This is an update of the review published in The Cochrane Library (2011, Issue 11).
OBJECTIVES
To assess the effectiveness, safety, tolerability and costs of interventions to reduce blood loss during myomectomy.
SEARCH METHODS
In June 2014, we conducted electronic searches in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO, and trial registers for ongoing and registered trials.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) that compared potential interventions to reduce blood loss during myomectomy to placebo or no treatment.
DATA COLLECTION AND ANALYSIS
The two authors independently selected RCTs for inclusion, assessed the risk of bias and extracted data from the included RCTs. The primary review outcomes were blood loss and need for blood transfusion. We expressed study results as mean differences (MD) for continuous data and odds ratios for dichotomous data, with 95% confidence intervals (CI). We assessed the quality of evidence using GRADE methods.
MAIN RESULTS
Eighteen RCTs with 1250 participants met our inclusion criteria. The studies were conducted in hospital settings in low, middle and high income countries.Blood lossWe found significant reductions in blood loss with the following interventions: vaginal misoprostol (2 RCTs, 89 women: MD -97.88 ml, 95% CI -125.52 to -70.24; I(2) = 43%; moderate-quality evidence); intramyometrial vasopressin (3 RCTs, 128 women: MD -245.87 ml, 95% CI -434.58 to -57.16; I(2) = 98%; moderate-quality evidence); intramyometrial bupivacaine plus epinephrine (1 RCT, 60 women: MD -68.60 ml, 95% CI -93.69 to -43.51; low-quality evidence); intravenous tranexamic acid (1 RCT, 100 women: MD -243 ml, 95% CI -460.02 to -25.98; low-quality evidence); gelatin-thrombin matrix (1 RCT, 50 women: MD -545.00 ml, 95% CI -593.26 to -496.74; low-quality evidence); intravenous ascorbic acid (1 RCT, 102 women: MD -411.46 ml, 95% CI -502.58 to -320.34; low-quality evidence); vaginal dinoprostone (1 RCT, 108 women: MD -131.60 ml, 95% CI -253.42 to -9.78; low-quality evidence); loop ligation of the myoma pseudocapsule (1 RCT, 70 women: MD -305.01 ml, 95% CI -354.83 to -255.19; low-quality evidence); and a fibrin sealant patch (1 RCT, 70 women: MD -26.50 ml, 95% CI -44.47 to -8.53; low-quality evidence). We found evidence of significant reductions in blood loss with a polyglactin suture (1 RCT, 28 women: MD -1870.0 ml, 95% CI -2547.16 to 1192.84) or a Foley catheter (1 RCT, 93 women: MD -240.70 ml, 95% CI -359.61 to -121.79) tied around the cervix. However, pooling data from these peri-cervical tourniquet RCTs revealed significant heterogeneity of the effects (2 RCTs, 121 women: MD (random) -1019.85 ml, 95% CI -2615.02 to 575.32; I(2) = 95%; low-quality evidence). There was no good evidence of an effect on blood loss with oxytocin, morcellation or clipping of the uterine artery.Need for blood transfusion We found significant reductions in the need for blood transfusion with vasopressin (2 RCTs, 90 women: OR 0.15, 95% CI 0.03 to 0.74; I(2) = 0%; moderate-quality evidence); peri-cervical tourniquet (2 RCTs, 121 women: OR 0.09, 95% CI 0.01 to 0.84; I(2) = 69%; low-quality evidence); gelatin-thrombin matrix (1 RCT, 100 women: OR 0.01, 95% CI 0.00 to 0.10; low-quality evidence) and dinoprostone (1 RCT, 108 women: OR 0.17, 95% CI 0.04 to 0.81; low-quality evidence), but no evidence of effect on the need for blood transfusion with misoprostol, oxytocin, tranexamic acid, ascorbic acid, loop ligation of the myoma pseudocapsule and a fibrin sealant patch.There were insufficient data on the adverse effects and costs of the different interventions.
AUTHORS' CONCLUSIONS
At present there is moderate-quality evidence that misoprostol may reduce bleeding during myomectomy, and low-quality evidence that bupivacaine plus epinephrine, tranexamic acid, gelatin-thrombin matrix, a peri-cervical tourniquet, ascorbic acid, dinoprostone, loop ligation and a fibrin sealant patch may reduce bleeding during myomectomy. There is no evidence that oxytocin, morcellation and temporary clipping of the uterine artery reduce blood loss. Further well designed studies are required to establish the effectiveness, safety and costs of different interventions for reducing blood loss during myomectomy.
Topics: Blood Loss, Surgical; Blood Transfusion; Female; Hemostasis, Surgical; Hemostatics; Humans; Leiomyoma; Randomized Controlled Trials as Topic; Tourniquets; Uterine Neoplasms
PubMed: 25125317
DOI: 10.1002/14651858.CD005355.pub5 -
PloS One 2013Prolapse of the fallopian tube into the vaginal vault is a rarely reported complication that may occur after hysterectomy. Clinicians can miss the diagnosis of this... (Review)
Review
BACKGROUND
Prolapse of the fallopian tube into the vaginal vault is a rarely reported complication that may occur after hysterectomy. Clinicians can miss the diagnosis of this disregarded complication when dealing with post-hysterectomy vaginal bleeding.
OBJECTIVES
We performed a systematic review in order to describe the clinical presentation, therapeutic management and outcome of fallopian tube prolapse occurring after hysterectomy.
SEARCH STRATEGY
A systematic search of MEDLINE and EMBASE references from January 1980 to December 2010 was performed. We included articles that reported cases of fallopian tube prolapse after hysterectomy. Data from eligible studies were independently extracted onto standardized forms by two reviewers.
RESULTS
Twenty-eight articles including 51 cases of fallopian tube prolapse after hysterectomy were included in this systematic review. Clinical presentations included abdominal pain, dyspareunia, post- coital bleeding, and/or vaginal discharge. Two cases were asymptomatic and diagnosed at routine checkup. The surgical management reported comprised partial or total salpingectomy, with vaginal repair in some cases combined with oophorectomy using different approaches (vaginal approach, combined vaginal-laparoscopic approach, laparoscopic approach, or laparotomy). Six patients were initially treated by silver nitrate application without success.
CONCLUSIONS
This systematic review provided a precise summary of the clinical characteristics and treatment of patients presenting with fallopian tube prolapse following hysterectomy published in the past 30 years. We anticipate that these results will help inform current investigations and treatment.
Topics: Abdominal Pain; Dyspareunia; Fallopian Tube Diseases; Fallopian Tubes; Female; Humans; Hysterectomy; Postoperative Complications; Prolapse
PubMed: 24116117
DOI: 10.1371/journal.pone.0076543 -
The Cochrane Database of Systematic... Oct 2013Cervical cancer is the second most common cancer among women and is the most frequent cause of death from gynaecological cancers worldwide. Standard surgical management... (Comparative Study)
Comparative Study Review
BACKGROUND
Cervical cancer is the second most common cancer among women and is the most frequent cause of death from gynaecological cancers worldwide. Standard surgical management for selected early-stage cervical cancer is radical hysterectomy. Traditionally, radical hysterectomy has been carried out via the abdominal route and this remains the gold standard surgical management of early cervical cancer. In recent years, advances in minimal access surgery have made it possible to perform radical hysterectomy with the use of laparoscopy with the aim of reducing the surgical morbidity and promoting a faster recovery.
OBJECTIVES
To compare the effectiveness and safety of laparoscopically assisted radical vaginal hysterectomy (LARVH) and radical abdominal hysterectomy (RAH) in women with early-stage (1 to 2A) cervical cancer.
SEARCH METHODS
We searched the Cochrane Gynaecological Cancer Group Trials Register, and Cochrane Register of Controlled Trials (CENTRAL) Issue 7, 2013, MEDLINE, and EMBASE up to July 2013. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that compared laparoscopically assisted radical hysterectomy and radical abdominal hysterectomy, in adult women diagnosed with early (stage 1 to 2A) cervical cancer.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias.
MAIN RESULTS
We found one RCT, which included 13 women, that met our inclusion criteria and this trial reported data on LARVH versus RAH.Women who underwent LARVH for treatment of early-stage cervical cancer appeared to have less blood loss compared with those who underwent RAH. The trial reported a borderline significant difference between the two types of surgery (median blood loss 400 mL (interquartile range (IQR): 325 to 1050) and 1000 mL (IQR: 800 to 1025) for LARVH and RAH, respectively, P value = 0.05). RAH was associated with significantly shorter operation time compared with LARVH (median: 180 minutes with LARVH versus 138 minutes with RAH, P value = 0.05).There was no statistically significant difference in the risk of perioperative complications in women who underwent LARVH and RAH. The trial reported two (29%) and four (57%) cases of intraoperative and postoperative complications, respectively, in the LARVH group and no (0%) reported cases of intraoperative complications and five (83%) cases of postoperative complications in the RAH group. There were no reported cases of severe perioperative complications.Bladder and bowel dysfunction of either a transient or chronic nature remain major morbidities after radical hysterectomy, and the one included study showed that there may be significantly less after LARVH.
AUTHORS' CONCLUSIONS
The included trial lacked statistical power due to the small number of women in each group and the low number of observed events. Therefore, the absence of reliable evidence, regarding the effectiveness and safety of the two surgical techniques for the management of early-stage cervical cancer, precludes any definitive guidance or recommendations for clinical practice. The trial did not report data on long-term outcomes, but was at moderate risk of bias due to very low numbers of included women.
Topics: Adult; Female; Humans; Hysterectomy; Hysterectomy, Vaginal; Laparoscopy; Neoplasm Staging; Randomized Controlled Trials as Topic; Uterine Cervical Neoplasms
PubMed: 24085528
DOI: 10.1002/14651858.CD006651.pub3 -
The Cochrane Database of Systematic... Oct 2012It is possible that oestrogen deficiency may be an aetiological factor in the development of urinary incontinence in women. This is an update of a Cochrane review first... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
It is possible that oestrogen deficiency may be an aetiological factor in the development of urinary incontinence in women. This is an update of a Cochrane review first published in 2003 and subsequently updated in 2009.
OBJECTIVES
To assess the effects of local and systemic oestrogens used for the treatment of urinary incontinence.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register of trials (searched 21 June 2012) which includes searches of MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) and handsearching of journals and conference proceedings, and the reference lists of relevant articles.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials that included oestrogens in at least one arm in women with symptomatic or urodynamic diagnoses of stress, urgency or mixed urinary incontinence or other urinary symptoms post-menopause.
DATA COLLECTION AND ANALYSIS
Trials were evaluated for risk of bias and appropriateness for inclusion by the review authors. Data were extracted by at least two authors and cross checked. Subgroup analyses were performed by grouping participants under local or systemic administration. Where appropriate, meta-analysis was undertaken.
MAIN RESULTS
Thirty-four trials were identified which included approximately 19,676 incontinent women of whom 9599 received oestrogen therapy (1464 involved in trials of local vaginal oestrogen administration). Sample sizes of the studies ranged from 16 to 16,117 women. The trials used varying combinations of type of oestrogen, dose, duration of treatment and length of follow up. Outcome data were not reported consistently and were available for only a minority of outcomes.The combined result of six trials of systemic administration (of oral systemic oestrogens) resulted in worse incontinence than on placebo (risk ratio (RR) 1.32, 95% CI 1.17 to 1.48). This result was heavily weighted by a subgroup of women from the Hendrix trial, which had large numbers of participants and a longer follow up of one year. All of the women had had a hysterectomy and the treatment used was conjugated equine oestrogen. The result for women with an intact uterus where oestrogen and progestogen were combined also showed a statistically significant worsening of incontinence (RR 1.11, 95% CI 1.04 to 1.18).There was some evidence that oestrogens used locally (for example vaginal creams or pessaries) may improve incontinence (RR 0.74, 95% CI 0.64 to 0.86). Overall, there were around one to two fewer voids in 24 hours amongst women treated with local oestrogen, and there was less frequency and urgency. No serious adverse events were reported although some women experienced vaginal spotting, breast tenderness or nausea.Women who were continent and received systemic oestrogen replacement, with or without progestogens, for reasons other than urinary incontinence were more likely to report the development of new urinary incontinence in one large study.One small trial showed that women were more likely to have an improvement in incontinence after pelvic floor muscle training (PFMT) than with local oestrogen therapy (RR 2.30, 95% CI 1.50 to 3.52).The data were too few to address questions about oestrogens compared with or in combination with other treatments, different types of oestrogen or different modes of delivery.
AUTHORS' CONCLUSIONS
Urinary incontinence may be improved with the use of local oestrogen treatment. However, there was little evidence from the trials on the period after oestrogen treatment had finished and no information about the long-term effects of this therapy was given. Conversely, systemic hormone replacement therapy using conjugated equine oestrogen may worsen incontinence. There were too few data to reliably address other aspects of oestrogen therapy, such as oestrogen type and dose, and no direct evidence comparing routes of administration. The risk of endometrial and breast cancer after long-term use of systemic oestrogen suggests that treatment should be for limited periods, especially in those women with an intact uterus.
Topics: Estrogen Replacement Therapy; Estrogens; Female; Humans; Postmenopause; Randomized Controlled Trials as Topic; Urinary Incontinence; Urinary Incontinence, Stress
PubMed: 23076892
DOI: 10.1002/14651858.CD001405.pub3 -
The Cochrane Database of Systematic... Apr 2012This is an updated version of the original Cochrane review published in Issue 2, 2007. The role of radiotherapy (both pelvic external beam radiotherapy (EBRT) and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an updated version of the original Cochrane review published in Issue 2, 2007. The role of radiotherapy (both pelvic external beam radiotherapy (EBRT) and vaginal intracavity brachytherapy (VBT)) in stage I endometrial cancer following hysterectomy remains controversial.
OBJECTIVES
To assess the efficacy of adjuvant radiotherapy following surgery for stage I endometrial cancer.
SEARCH METHODS
We searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Specialised Register to end-2005 for the original review, and extended the search to January 2012 for the update.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared post-operative adjuvant radiotherapy (either EBRTor VBT, or both) versus no radiotherapy or VBT in women with stage I endometrial cancer.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials and extracted data to a specifically designed data collection form. The primary outcome was overall survival. Secondary outcomes were endometrial cancer-related deaths, locoregional recurrence and distant recurrence. Meta-analyses were performed using Cochrane Review Manager Software 5.1.
MAIN RESULTS
We included eight trials. Seven trials (3628 women) compared EBRT with no EBRT (or VBT), and one trial (645 women) compared VBTwith no additional treatment. We considered six of the eight trials to be of a high quality. Time-to-event data were not available for all trials and all outcomes.EBRT (with or without VBT) compared with no EBRT (or VBT alone) for stage I endometrial carcinoma significantly reduced locoregional recurrence (time-to-event data: five trials, 2965 women; Hazard Ratio (HR) 0.36, 95% Confidence Interval (CI) 0.25 to 0.52; and dichotomous data: seven trials, 3628 women; Risk Ratio (RR) 0.33, 95% CI 0.23 to 0.47). This reduced risk of locoregional recurrence did not translate into improved overall survival (time-to-event data: five trials, 2,965 women; HR 0.99, 95% CI 0.82 to1.20; and dichotomous data: seven trials, 3628 women; RR 0.98, 95% CI 0.83 to 1.15) or improved endometrial cancer-related survival (time-to-event data: five trials, 2965 women; HR 0.96, 95% CI 0.72 to 1.28; and dichotomous data: seven trials, 3628 women; RR 1.02, 95% CI 0.81 to 1.29) or improved distant recurrence rates (dichotomous data: seven trials, 3628 women; RR 1.04, 95% CI 0.80 to 1.35).EBRT did not improve survival outcomes in either the intermediate-risk or high-risk subgroups, although high-risk data were limited, and a benefit of EBRT for high-risk women could not be excluded. One trial (PORTEC-2) compared EBRT with VBT in the high-intermediate risk group and reported that VBT was effective in ensuring vaginal control with a non-significant difference in loco-regional relapse rate compared to EBRT (5.1% versus 2.1%; HR 2.08, 95% CI 0.71 to 6.09; P = 0.17). In the subgroup of low-risk patients (IA/B and grade 1/2), EBRT increased the risk of endometrial carcinoma-related deaths (including treatment-related deaths) (two trials, 517 women; RR 2.64, 95% CI 1.05 to 6.66) but there was a lack of data on overall survival. We considered the evidence for the low-risk subgroup to be of a low quality.EBRT was associated with significantly increased severe acute toxicity (two trials, 1328 patients, RR 4.68, 95% CI 1.35 to 16.16), increased severe late toxicity (six trials, 3501 women; RR 2.58, 95% CI 1.61 to 4.11) and significant reductions in quality of life scores and rectal and bladder function more than 10 years after randomisation (one trial, 351 women) compared with no EBRT.One trial of VBT versus no additional treatment in women with low-risk lesions reported a non-significant reduction in locoregional recurrence in the VBT group compared with the no additional treatment group (RR 0.39, (95% CI 0.14 to 1.09). There were no significant differences in survival outcomes in this trial.
AUTHORS' CONCLUSIONS
EBRT reduces the risk of locoregional recurrence but has no significant impact on cancer-related deaths or overall survival. It is associated with significant morbidity and a reduction in quality of life. There is no demonstrable survival advantage from adjuvant EBRT for high-risk stage I endometrial cancer, however, the meta-analyses of this subgroup were underpowered and also included high-intermediate risk women, therefore we cannot exclude a small benefit in the high-risk subgroup. EBRT may have an adverse effect on endometrial cancer survival when used to treat uncomplicated low-risk (IA/B grade 1/2) endometrial cancer. For the intermediate to high-intermediate risk group, VBT alone appears to be adequate in ensuring vaginal control compared to EBRT. Further research is needed to guide practice for lesions that are truly high risk. In addition, the definitions of risk should be standardised.
Topics: Endometrial Neoplasms; Female; Humans; Neoplasm Staging; Radiotherapy, Adjuvant; Randomized Controlled Trials as Topic; Survival Analysis
PubMed: 22513918
DOI: 10.1002/14651858.CD003916.pub4 -
BMJ Clinical Evidence Mar 2012Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59... (Review)
Review
INTRODUCTION
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with anterior vaginal wall prolapse? What are the effects of surgical treatments in women with posterior vaginal wall prolapse? What are the effects of surgical treatments in women with upper vaginal wall prolapse? What are the effects of using different surgical materials in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 15 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension; abdominal sacral colpopexy; abdominal sacrohysteropexy; anterior colporrhaphy with mesh reinforcement; laparoscopic surgery; mesh or synthetic grafts; native (autologous) tissue; open abdominal surgery; pelvic floor muscle exercises; posterior colporrhaphy (with or without mesh reinforcement); posterior intravaginal slingplasty (infracoccygeal sacropexy); sacrospinous colpopexy (vaginal sacral colpopexy); sutures; traditional anterior colporrhaphy; transanal repair; ultralateral anterior colporrhaphy alone or with cadaveric fascia patch; vaginal hysterectomy; vaginal oestrogen; vaginal pessaries; and vaginal sacrospinous colpopexy.
Topics: Female; Gynecologic Surgical Procedures; Humans; Hysterectomy, Vaginal; Incidence; Pelvic Floor; Prolapse; Surgical Mesh; Uterine Prolapse; Vagina
PubMed: 22414610
DOI: No ID Found