(1) Objective: We aimed to report an update of the systematic review and meta-analysis by Baekelandt et al. (2016). (2) Method: We followed PRISMA guidelines to perform this systematic review. We ...searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. (3) Results: Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra- and postoperative complications, readmission, pain scores at 24 h postoperative and change in hemoglobin (Hb) on day 1 postoperative.
Abstract Objective To critically appraise studies comparing benefits and harms in women with benign disease without prolapse undergoing hysterectomy by natural orifice transluminal endoscopic surgery ...(NOTES) versus laparoscopy. Study design We followed the PRISMA guidelines. We searched MEDLINE, EMBASE and CENTRAL for randomised controlled trials (RCTs), controlled clinical trials (CCTs) and cohort studies comparing NOTES with laparoscopy assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH) in women bound to undergo removal of a non-prolapsed uterus for benign disease. Two authors searched and selected studies, extracted data and assessed the risk of bias independently. Any disagreement was resolved by discussion or arbitration. Results We did not find RCTs but retrieved two retrospective cohort studies comparing NOTES with LAVH. The study quality as assessed by the Newcastle-Ottawa scale was acceptable. Both studies reported no conversions. The operative time in women treated by NOTES was shorter compared to LAVH: the mean difference (MD) was −22.04 minutes (95% CI −28.00 minutes to −16.08 minutes; 342 women; 2 studies).There were no differences for complications in women treated by NOTES compared to LAVH: the risk ratio (RR) was 0.57 (95% CI 0.17 to 1.91; 342 women; 2 studies). The length of stay was shorter in women treated by NOTES versus LAVH: the MD was −0.42 days (95% CI −0.59 days to −0.25 days; 342 women; 2 studies). There were no differences for the median VAS scores at 12 hours between women treated by NOTES (median 2, range 0 to 6) or by LAVH (median 2, range 0 to 6) (48 women, 1 study). There were no differences in the median additional analgesic dose request in women treated by NOTES (median 0, range 0 to 6) or by LAVH (median 1, range 0 to 5) (48 women, 1 study). The hospital charges for treatment by NOTES were higher compared to LAVH: the mean difference was 137.00 € (95% CI 88.95 € to 185.05 €; 294 women; 1 study). Conclusions At the present NOTES should be considered as a technique under evaluation for use in gynaecological surgery. RCTs are needed to demonstrate its effectiveness.
IntroductionHysterectomy is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared ...with abdominal hysterectomy. Hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES, vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH).MethodsMulticentre pragmatic RCT aiming to recruit 1000 women aged 18–75 years undergoing hysterectomy for benign disease. The RCT includes two identical substudies (groups A and B). If VH is considered safe and feasible, the patient will be randomised within group A (VH vs vNOTES). If VH is not considered safe or feasible, patients will be randomised within group B (LH vs vNOTES).AnalysisPrimary outcome is the proportion of women leaving the hospital within 12 hours after surgery. Secondary outcomes are hospitalisation time, conversion rates, duration of the surgical procedure, intraoperative complications, postoperative complications and readmission.Ethics and disseminationThe Ethical Board Committee at Imelda Hospital, Bonheiden, Belgium, has approved the research protocol 230704 (principal investigator). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.Trial registration number NCT05971875.
Introduction and hypothesis
Pregnancy and childbirth are considered risk factors for pelvic floor dysfunction, including anorectal dysfunction. We aimed to assess the effect of obstetric events on ...anal incontinence and constipation after delivery.
Methods
We systematically reviewed the literature by searching MEDLINE, Embase and CENTRAL. We included studies in women after childbirth examining the association between obstetric events and anorectal dysfunction assessed through validated questionnaires. We selected eligible studies and clustered the data according to the type of dysfunction, obstetric event and interval from delivery. We assessed risk of bias using the Newcastle Ottawa Scale and we performed a random-effects meta-analysis and reported the results as odds ratios (ORs) with their 95% confidence intervals. Heterogeneity across studies was assessed using I
2
statistics.
Results
Anal sphincter injury (OR: 2.44 1.92–3.09) and operative delivery were risk factors for anal incontinence (forceps—OR :1.35 1.12–1.63; vacuum—OR: 1.17 1.04–1.31). Spontaneous vaginal delivery increased the risk of anal incontinence compared with caesarean section (OR: 1.27 1.07–1.50). Maternal obesity (OR:1.48 1.28–1.72) and advanced maternal age (OR: 1.56 1.30–1.88) were risk factors for anal incontinence. The evidence on incontinence is of low certainty owing to the observational nature of the studies. No evidence was retrieved regarding constipation after delivery because of a lack of standardised validated assessment tools.
Conclusions
Besides anal sphincter injury, forceps delivery, maternal obesity and advanced age were associated with higher odds of anal incontinence, whereas caesarean section is protective. We could not identify obstetric risk factors for postpartum constipation, as few prospective studies addressed this question and none used a standardised validated questionnaire.
Abstract
STUDY QUESTION
Can the priorities for future research in infertility be identified?
SUMMARY ANSWER
The top 10 research priorities for the four areas of male infertility, female and ...unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified.
WHAT IS KNOWN ALREADY
Many fundamental questions regarding the prevention, management and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems.
STUDY DESIGN, SIZE, DURATION
Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Healthcare professionals, people with fertility problems and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance.
MAIN RESULTS AND THE ROLE OF CHANCE
The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties was entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI and IVF) and ethics, access and organization of care were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research and population science.
LIMITATIONS, REASONS FOR CAUTION
We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgment and arbitrary consensus definitions.
WIDER IMPLICATIONS OF THE FINDINGS
We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, will help research funding organizations and researchers to develop their future research agenda.
STUDY FUNDING/COMPETING INTEREST(S)
The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand and Maurice and Phyllis Paykel Trust. G.D.A. reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. A.W.H. reports research sponsorship from the Chief Scientist’s Office, Ferring, Medical Research Council, National Institute for Health Research and Wellbeing of Women and consultancy fees from AbbVie, Ferring, Nordic Pharma and Roche Diagnostics. M.L.H. reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. N.P.J. reports research sponsorship from AbbVie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics and Vifor Pharma. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from AbbVie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. E.H.Y.N. reports research sponsorship from Merck. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring and retains a financial interest in NexHand. J.S. reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring and being a clinical subeditor of Human Fertility. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their ‘traffic light’ system for infertility treatment ‘add-ons’. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form.
TRIAL REGISTRATION NUMBER
N/A.
IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural orifices to access the cavities of the human body to perform surgical interventions. NOTES limits the magnitude of ...surgical trauma and potentially reduces postoperative pain. Our group published a protocol on a randomised study comparing transvaginal NOTES (vNOTES) versus laparoscopy for hysterectomy (HALON). We simultaneously designed a similar randomised controlled trial (RCT) comparing vNOTES with laparoscopy for adnexectomy. To the best of our knowledge, this is the first RCT comparing vNOTES with laparoscopy for adnexal surgery.Methods and analysisThe methodology of the Notes Adnexectomy for Benign Indication versus Laparoscopic Excision (NOTABLE) study is similar to that of the HALON trial. Women aged 18–70 years with an indication for benign adnexal surgery will be eligible. We will use stratification according to adnexal size. Entrants will be randomised to the laparoscopic treatment (control) or vNOTES (intervention). Participants will be evaluated on days 0–7 and at 3 and 6 months. The primary outcome will be the proportion of women successfully treated by removing an adnexa by the allocated technique without conversion. We will collect the following data (secondary outcomes): proportion of women hospitalised on the day of surgery, postoperative pain scores measured two times per day from day 1 to 7, total dosage of pain killers used from day 1 to 7, hospital readmission during the first 6 weeks, dyspareunia and sexual well-being at baseline, 3 and 6 months using a validated questionnaire (Short Sexual Functioning Scale), health-related quality of life at baseline, 3 and 6 months after surgery using a validated questionnaire (EQ-5D-3L), duration of surgical intervention, infection or other surgical complications and direct costs up to 6 weeks following surgery. For the primary outcome measure, a one-sided 95% CI of the difference in the proportions of women with a successful removal of the uterus by the randomised technique will be estimated. Non-inferiority will be concluded when 15% lies above the upper limit of this 95% CI.Ethics and disseminationThe study was approved on 1 December 2015 by the EthicsCommitteeof the Imelda Hospital (registration no: 689), Bonheiden, Belgium. We aim to present the final results of the NOTABLE trial in peer-reviewed journals and at scientific meetings within 4 years after the start of the recruitment.Trial registration numberNCT02630329.
IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical ...trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy.Methods and analysisAll women aged 18–70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1–7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary.Ethics and disseminationThe study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment.Trial registration numberNCT02631837; Pre-results.
The aim of the study was to assess the postpartum risk for glucose intolerance since the introduction of the 'International Association of Diabetes and Pregnancy Study Groups' (IADPSG) criteria for ...gestational diabetes mellitus (GDM). Studies published since 2010 were included, which evaluated the risk for type 2 diabetes mellitus (T2DM), impaired glucose tolerance (IGT), and cardiovascular (CV) events in women with previous GDM compared to normal glucose tolerant women. We included forty-three studies, evaluating 4,923,571 pregnant women of which 5.8% (284,312) had a history of GDM. Five studies used IADPSG criteria (
= 6174 women, 1314 with GDM). The overall pooled relative risk (RR) for postpartum T2DM was 7.42 (95% CI: 5.99-9.19) and the RR for postpartum T2DM with IADPSG criteria was 6.45 (95% CI: 4.74-8.77) compared to the RR of 9.08 (95% CI: 6.96-11.85;
= 0.17) for postpartum T2DM based on other diagnostic criteria. The RR for postpartum IGT was 2.45 (95% CI: 1.92-3.13), independent of the criteria used. None of the available studies with IADPSG criteria evaluated the risk for CV events. Women with a history of GDM based on the IADPSG criteria have a similarly increased risk for postpartum glucose intolerance compared to GDM based on other diagnostic criteria. More studies with GDM based on the IADPSG criteria are needed to increase the quality of evidence concerning the long-term metabolic risk.
PDF
