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    Other relevant studies

    Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.

    Table 5 additional studies identified

    Article

    Number of patients and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Aharoni, S., Matanes, E., Lauterbach, R., Mor, O., Weiner, Z., & Lowenstein, L. (2021). Transvaginal natural orifice transluminal endoscopic versus conventional vaginal hysterectomy with uterosacral ligament suspension for apical compartment prolapse. European Journal of Obstetrics & Gynecology and Reproductive Biology, 260, 203-207.

    Retrospective cohort

    n=135

    Lower mean operative time (p<0.005), fewer intraoperative complications (p<0.05), less blood loss (p<0.05) and longer median hospital stay (p<0.05) in the vNOTES uterosacral ligament suspension group compared with the conventional group.

    Prolapse not focal to this overview.

    Badiglian‐Filho, L., Chaves Faloppa, C., Narciso de Oliveira Menezes, A., Mantoan, H., Kumagai, L. Y., & Baiocchi, G. (2021). Vaginally assisted NOTES hysterectomy with adnexectomy (vNOTES) compared with conventional laparoscopy. A retrospective observational cohort study. International Journal of Gynecology & Obstetrics, 153(2), 351-356.

    Retrospective cohort

    n=86

    No statistically significant differences in complications, conversions, reoperations or hospital stays between vNOTES hysterectomy (and adnexectomy) and conventional laparoscopy.

    0 complications reported in both groups.

    Studies with larger samples were included.

    Baekelandt, J. F., De Mulder, P. A., Le Roy, I., Mathieu, C., Laenen, A., Enzlin, P., ... & Bosteels, J. J. (2018). Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. BMJ open, 8(1), e018059.

    Study protocol

    Study which was produced from this trial is included as the Baekelandt (2021) RCT

    Baekelandt, J., & Cavens, D. (2016). GelPOINT (Applied Medical) is a suitable port for transvaginal NOTES procedures. Journal of Gynecologic Surgery, 32(5), 257-262.

    Retrospective cohort

    n=110

    110 successful vNOTES hysterectomy (n=77) and adnexal (n=33) procedures.

    Evidence of vNOTES being efficacious and safe with the GelPOINT port.

    Device-focused study

    Baekelandt, J., De Mulder, P. A., Le Roy, I., Mathieu, C., Laenen, A., Enzlin, P., ... & Bosteels, J. J. (2016). HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol). BMJ open, 6(8), e011546.

    Study protocol

    Study which was produced from this trial is included in the Housmans (2020) systematic review

    Basol, G., Cora, A. O., Gundogdu, E. C., Mat, E., Yildiz, G., Kuru, B., ... & Kale, A. (2021). Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery versus single‐port laparoscopy: Comparison of early outcomes. Journal of Obstetrics and Gynaecology Research, 47(9), 3288-3296.

    Retrospective cohort

    n=60

    vNOTES was significantly superior to single-port laparoscopy for length of hospital stay and pain at 1 and 18 hours postop.

    0 complications in the vNOTES arm which was statistically significant (p=0.023).

    Studies with larger samples were included.

    Corcoran, C., Taylor, L., Thomas, L., Mason, A., Bush, S., & Bush, S. (2021). Vaginal Natural Orifice Transluminal Endoscopic Surgery: A Pilot Study in a Residency Training Program. Journal of Gynecologic Surgery, 37(3), 232-235.

    Retrospective pilot study

    n=29

    2 out of 29 vNOTES adnexal surgeries alongside hysterectomy were converted to traditional surgery.

    1 readmission required for a vaginal cuff hematoma.

    0 intraoperative complications occurred.

    Studies with larger samples were included.

    Kaya, C., Alay, I., Cengiz, H., Yıldız, G. O., Baghaki, H. S., & Yasar, L. (2021). Comparison of hysterectomy cases performed via conventional laparoscopy or vaginally assisted natural orifice transluminal endoscopic surgery: a paired sample cross-sectional study. Journal of Obstetrics and Gynaecology, 41(3), 434-438.

    Cross-sectional study

    n=99

    After matching, n=30 in vNOTES hysterectomy and 30 in total laparoscopic hysterectomy.

    Mean vNOTES operative time is 44 minutes shorter than laparoscopy (p<0.001).

    Mean vNOTES hospital stay is 15 hours shorter than laparoscopy (p=0.004).

    Included in the Housmans (2020) systematic review

    Kaya, C., Yıldız, Ş., Alay, İ., Karakaş, S., Durmuş, U., Güraslan, H., & Ekin, M. (2022). Comparison of surgical outcomes of total laparoscopic hysterectomy and vNOTES hysterectomy for undescended-enlarged uteri. Journal of Investigative surgery, 35(4), 918-923.

    Cross-sectional study

    n=78

    115-minute shorter operative time (p<0.001) and 24-hour shorter hospitalisation (p<0.001) and lower median 24-hour VAS pain score (p=0.003) with vNOTES hysterectomy than total laparoscopic hysterectomy.

    Studies with larger samples focussing on uterine size were included.

    Kim, M. S., Noh, J. J., & Kim, T. J. (2021). Hysterectomy and adnexal procedures by vaginal natural orifice transluminal endoscopic surgery (VNH): initial findings from a Korean surgeon. Frontiers in Medicine, 7, 583147.

    Prospective cohort

    n=34

    Complications occurred in 3 out of 34 people. 2 cases of bladder injury and 1 person needed transumbilical single-port surgery because of late-onset postoperative bleeding on the thirteenth postoperative day.

    Statistically significant correlation between longer port-installation time and greater pain (4+ VAS pain score) (p=0.013).

    Surgeon experience/learning curve focus.

    Koythong, T., Thigpen, B., Sunkara, S., Erfani, H., Delgado, S., & Guan, X. (2021). Surgical outcomes of hysterectomy via robot-assisted versus traditional transvaginal natural orifice transluminal endoscopic surgery. Journal of minimally invasive gynecology, 28(12), 2028-2035.

    Retrospective cohort

    n=114

    Robotically assisted vNOTES seems like a safe and feasible option.

    None of the R-vNOTES procedures needed conversion (but not a statistically significant difference).

    No difference between traditional or robotic vNOTES for operative time, blood loss, length of hospital stay or pain at 1, 2 and 3 weeks postop.

    Robotic assistance not focal to this overview.

    Li, C. B., & Hua, K. Q. (2020). Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: a systematic review. Asian journal of surgery, 43(1), 44-51.

    Literature review

    vNOTES is a promising procedure across many indications.

    Many small studies with disparate cohorts and procedures.

    Many studies reported no, or low, complications.

    Review of literature. Many studies with small samples and no (pooled) analysis.

    Liu, J., Tan, L., Thigpen, B., Koythong, T., Zhou, X., Liu, Q., ... & Guan, X. (2022). Evaluation of the learning curve and safety outcomes in robotic assisted vaginal natural orifice transluminal endoscopic hysterectomy: a case series of 84 patients. The International Journal of Medical Robotics and Computer Assisted Surgery, 18(3), e2385.

    Retrospective cohort

    n=84

    2 out of 84 R-vNOTES hysterectomy procedures needed conversion to robotic assisted laparoscopy.

    15.48% (13/84) complication rate including 2 CD-I, 9 CD-II and 2 CD-III grade complications. Mean hospital stay is 0 days.

    Mean postoperative pain VAS score was reduced by 2.36 (p=0.001) at 2 weeks and by 4.36 (p=0.001) at 3 weeks, when compared with preoperative pain.

    Learning curve and robotic-assistance focus.

    Merlier, M., Collinet, P., Pierache, A., Vandendriessche, D., Delporte, V., Rubod, C., ... & Giraudet, G. (2022). Is V-NOTES hysterectomy as safe and feasible as outpatient surgery compared with vaginal hysterectomy?. Journal of Minimally Invasive Gynecology, 29(5), 665-672.

    Retrospective cohort

    n=100

    No statistical difference in intra- or postoperative complications, length of hospital stay and conversions between groups.

    0 readmissions in the vNOTES group and 2 in the vaginal group but not a statistically significant difference.

    Studies with larger samples were included.

    Noh, J. J., Kim, M. S., Kang, J. H., Jung, J. H., Chang, C. S., Jeon, J., & Kim, T. J. (2022). Comparison of surgical outcomes of hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) versus single-port access (SPA) surgery. Journal of Personalized Medicine, 12(6), 875.

    Prospective cohort

    n=73

    VAS pain score was significantly lower in the vNOTES group than the laparoscopy group.

    Average port installation was 13 minutes longer in the vNOTES group (p<0.001) but time for vaginal closure and total operative time were shorter (p<0.001).

    1 complication reported which was injury to the distal ureter in the vNOTES group.

    No conversion procedures needed.

    Studies with larger samples were included.

    Nulens, K., Bosteels, J., De Rop, C., & Baekelandt, J. (2021). vNOTES hysterectomy for large uteri: a retrospective cohort study of 114 patients. Journal of Minimally Invasive Gynecology, 28(7), 1351-1356.

    Retrospective cohort

    n=114

    4 complications in 114 procedures; 3 postoperative bleeding complications and 1 minor late complication.

    1 conversion to laparotomy needed.

    Operative time positively associated with uterine size.

    Studies with larger samples were included.

    Ozceltik, G., Hortu, I., Itil, I. M., & Yeniel, A. O. (2022). Vaginal approach versus laparoscopy for hysterectomy in transgender men. Journal of Gynecology Obstetrics and Human Reproduction, 51(2), 102286.

    Retrospective cohort

    n=90

    No intraoperative complications or conversions in the vNOTES hysterectomy group.

    1 reoperation in the vNOTES group because of late-onset intraabdominal bleeding.

    Median operative time was 25 minutes shorter and mean hospital stay was shorter in the vNOTES arm (p<0.001).

    Lower VAS pain scores at 12 and 24 hours postop (p<0.001), but no difference at 2, 6 or 48 hours.

    1 complication in the laparoscopy group.

    Studies with larger samples were included.

    Puisungnoen, N., Yantapant, A., & Yanaranop, M. (2020). Natural orifice transluminal endoscopic surgery-assisted vaginal hysterectomy versus total laparoscopic hysterectomy: a single-center retrospective study using propensity score analysis. Gynecology and Minimally Invasive Therapy, 9(4), 227.

    Retrospective cohort

    n=100

    No difference between vNOTES hysterectomy and total laparoscopic hysterectomy for operative time, complications or requirement of blood transfusion.

    Statistically significant difference for less pain and shorter length of stay for vNOTES.

    More pertinent studies were included.

    Wang, C. J., Go, J., Huang, H. Y., Wu, K. Y., Huang, Y. T., Liu, Y. C., & Weng, C. H. (2019). Learning curve analysis of transvaginal natural orifice transluminal endoscopic hysterectomy. BMC surgery, 19, 1-7.

    Retrospective cohort

    n=240

    239 out of 240 procedures completed successfully. 1 procedure was converted to laparoscopy. Blood transfusion in 5.4% of procedures. Complications in 5 procedures. Transfusion, complications and uteri size had statistically significant impacts on operation time.

    Learning curve focus

    Wang, C. J., Huang, H. Y., Huang, C. Y., & Su, H. (2015). Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery for nonprolapsed uteri. Surgical endoscopy, 29, 100-107.

    Retrospective cohort

    n=512

    vNOTES hysterectomy leads to less blood loss (p<0.001) and fewer blood transfusions (p=0.004) compared with laparoscopically assisted vaginal hysterectomy.

    Efficiency: vNOTES hysterectomy is on average a 21-minute quicker procedure (p<0.001) and leads to shorter in-hospital stays (p<0.001).

    Included in the Housmans (2020) systematic review

    Wang, X., Li, J., Hua, K., & Chen, Y. (2020). Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy for uterus weighing≥ 1 kg. BMC surgery, 20, 1-7.

    Retrospective cohort

    n=39

    Blood transfusion in 5.1% of procedures. 3 out of 39 (7.7%) procedures needed a conversion to laparoscopy because of being unable to posterior colpotomy.

    Statistically significant improvements in operation time, blood loss and hospital stay following first 20 procedures (learning curve).

    Studies with larger samples were included.

    Weerakiet, S., Uckara, W., Soimongkol, K., Daungroedeeswas, R., Pongphonkit, J., Chanasabaeng, S., & Sutjaritphong, P. (2021). Comparison of surgical outcomes between natural orifice transluminal endoscopic surgery for hysterectomy and conventional total laparoscopic hysterectomy. JOURNAL OF THE MEDICAL ASSOCIATION OF THAILAND, 104(8), 1255-62.

    Retrospective cohort

    n=65

    Lower operative time (p<0.0001) and lower median VAS pain scores at 6, 24 and 48 hours (p<0.001) in the vNOTES hysterectomy group compared with total laparoscopic hysterectomy.

    Statistically significant lower need for added analgesics in the vNOTES group (p=0.001).

    Studies with larger samples were included.

    Yang, C. Y., Shen, T. C., Lin, C. L., Chang, Y. Y., Huang, C. C., & Lin, W. C. (2020). Surgical outcomes of hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) compared with laparoscopic total hysterectomy (LTH) in women with non-prolapsed and benign uterine diseases. Taiwanese Journal of Obstetrics and Gynecology, 59(4), 565-569.

    Retrospective chart analysis

    n=183

    No difference between vNOTES hysterectomy and total laparoscopic hysterectomy for operative time, blood loss, uterine weight, decrease in haemoglobin level on postoperative day 1, complications, hospital stay and readmission rate.

    Statistically significantly less pain in vNOTES group for postoperative pain.

    Included in the Housmans (2020) systematic review

    Yang, E., Nie, D., & Li, Z. (2019). Comparison of major clinical outcomes between transvaginal notes and traditional laparoscopic surgery: a systematic review and meta-analysis. Journal of Surgical Research, 244, 278-290.

    Systematic review and meta-analysis

    n=1,340

    No difference between vNOTES and laparoscopy for risk of complications.

    Positive findings regarding pain and recovery for people having vNOTES.

    Most studies did, or patients had, cholecystectomy – 2 out of 13 studies pertinent.