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      Vaginal assisted NOTES hysterectomy in The Netherlands; A prospective cohort study

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          Abstract

          Objectives

          Vaginal assisted Natural Orifice Transluminal Endoscopic Surgery (NOTES) combines the benefits of vaginal and endoscopic surgery. This study presents the results of the first vaginal assisted NOTES hysterectomies (VANH) in The Netherlands.

          Study design

          A prospective cohort study was performed in two non-academic teaching hospitals in The Netherlands. Data was collected from patients who underwent a VANH for benign indications between August 2019 and April 2023. Baseline characteristics and data of intra- and postoperative surgical outcomes were recorded and analysed. The VANHs were performed by four experienced vaginal and endoscopic gynaecological surgeons.

          Results

          A total of 200 patients underwent a VANH. Indications were dysfunctional menstrual bleeding (61 %; n = 122), abnormal cervical cytology (15.5 %; n = 31), abdominal pain (11.5 %; n = 23), post ablation/sterilization pain syndrome (3.5 %; n = 7), uterine fibroids (5.0 %; n = 10), atypical endometrial hyperplasia (2.5 %; n = 5) and Lynch or BRCA gene mutation carriers (1.0 %, n = 2). The mean surgical time was 61.4 min ( ± 22.8 min) with a mean blood loss of 88 mL ( ± 89 mL) and a mean uterine weight of 150 g ( ± 112 g). In 2.0 % (n = 4) of the cases a conversion was necessary. Same day discharge (SDD) was feasible in 80.2 % (n = 105) of the patients planned in day-care. In 2.0 % (n = 4) an intra-operative complication and in 9.0 % (n = 18) a post-operative complication occurred.

          Conclusion

          This study shows vNOTES to be a safe and feasible surgical technique and can be safely implemented with appropriate patient selection and skilled surgeons. It highlights the importance of surgeon awareness of the challenges inherent in the initial stages of the implementation of a new surgical technique when performing their first vNOTES procedures. Additional randomized clinical trials are needed to show superiority of vNOTES compared to traditional surgery.

          Highlights

          • Vaginal Assisted NOTES hysterectomy is a safe and feasible surgical technique.

          • Appropriate patient selection during a learning curve is important.

          • More research to Vaginal Assisted NOTES hysterectomy is necessary.

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          Most cited references30

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          External validity of randomised controlled trials: "to whom do the results of this trial apply?".

          In making treatment decisions, doctors and patients must take into account relevant randomised controlled trials (RCTs) and systematic reviews. Relevance depends on external validity (or generalisability)--ie, whether the results can be reasonably applied to a definable group of patients in a particular clinical setting in routine practice. There is concern among clinicians that external validity is often poor, particularly for some pharmaceutical industry trials, a perception that has led to underuse of treatments that are effective. Yet researchers, funding agencies, ethics committees, the pharmaceutical industry, medical journals, and governmental regulators alike all neglect external validity, leaving clinicians to make judgments. However, reporting of the determinants of external validity in trial publications and systematic reviews is usually inadequate. This review discusses those determinants, presents a checklist for clinicians, and makes recommendations for greater consideration of external validity in the design and reporting of RCTs.
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            No surgical innovation without evaluation: the IDEAL recommendations.

            Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.
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              • Record: found
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              • Article: not found

              Surgical approach to hysterectomy for benign gynaecological disease.

              The four approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic-assisted hysterectomy (RH).
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                Author and article information

                Contributors
                Journal
                Eur J Obstet Gynecol Reprod Biol X
                Eur J Obstet Gynecol Reprod Biol X
                European Journal of Obstetrics & Gynecology and Reproductive Biology: X
                Elsevier
                2590-1613
                02 July 2024
                September 2024
                02 July 2024
                : 23
                : 100323
                Affiliations
                [a ]Department of Obstetrics & Gynecology, Zuyderland Medical Centre Heerlen, Henri Dunantstraat 5, 6419 PC Heerlen, Limburg, the Netherlands
                [b ]Department of Obstetrics & Gynecology, Catharina Hospital Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands
                [c ]Department Obstetrics and Gynecology, Universitair Ziekenhuis Gent, Corneel Heymanslaan 10, 9000 Gent, Oost-Vlaanderen, Belgium
                [d ]GROW School for Oncology and Reproduction, Maastricht University Medical Centre, Maastricht, the Netherlands
                [e ]Maastricht University, Maastricht, the Netherlands
                Author notes
                [* ]Corresponding author at: Department of Obstetrics & Gynecology, Zuyderland Medical Centre Heerlen, Henri Dunantstraat 5, 6419 PC Heerlen, Limburg, the Netherlands. il.bekkers@ 123456zuyderland.nl
                Article
                S2590-1613(24)00043-7 100323
                10.1016/j.eurox.2024.100323
                11292541
                39091980
                c9b2c712-1e07-46a3-ab29-996d35806961
                © 2024 The Authors

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                : 11 April 2024
                : 8 June 2024
                : 16 June 2024
                Categories
                Gynaecology

                vaginal hysterectomy,vnotes,vaginal assisted notes hysterectomy,laparoscopy

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