Abstract
Purpose: Natural Orifice Transluminal Endoscopic Surgery (NOTES), introduced in 2004, utilizes natural orifices for surgical access. Vaginal NOTES (vNOTES) is a recent adaptation in OB/GYN. Our primary objective was to evaluate the current landscape of clinical trials involving vNOTES in this field.
Design methods: We conducted a cross-sectional analysis of the National Library of Medicine’s Clinical Trial Database, focusing on vNOTES clinical trials in OB/GYN from January 2004 to November 2023. Inclusion criteria included interventional trials related to OB/GYN. Data extraction included conditions studied, design, trial status, location, enrollment, and adverse effects.
Results: Among the initial 40 trials returned from this search, 19 were excluded due to irrelevance to OB/GYN. The remaining 21 trials included conditions such as uterine diseases/hysterectomy (23.8%), pelvic organ prolapse (23.8%), and ovarian diseases/salpingectomy/salpingo-oophorectomy (19%). The majority of these trials were conducted in Europe (90.5%), with only 2 trials in the United States (9.5%). Five trials (23.8%) were completed, with only 1 reporting results (4.7%). Completed trials regarding vNOTES indicated fewer adverse events compared to laparoscopic surgery.
Conclusion: vNOTES appears promising, with evidence suggesting fewer postoperative complications than laparoscopic surgery. However, further research is needed to establish guidelines and assess the broader application of vNOTES in OB/GYN. Despite limited clinical trials, vNOTES may be beneficial for patients suitable for vaginal hysterectomy
Design methods: We conducted a cross-sectional analysis of the National Library of Medicine’s Clinical Trial Database, focusing on vNOTES clinical trials in OB/GYN from January 2004 to November 2023. Inclusion criteria included interventional trials related to OB/GYN. Data extraction included conditions studied, design, trial status, location, enrollment, and adverse effects.
Results: Among the initial 40 trials returned from this search, 19 were excluded due to irrelevance to OB/GYN. The remaining 21 trials included conditions such as uterine diseases/hysterectomy (23.8%), pelvic organ prolapse (23.8%), and ovarian diseases/salpingectomy/salpingo-oophorectomy (19%). The majority of these trials were conducted in Europe (90.5%), with only 2 trials in the United States (9.5%). Five trials (23.8%) were completed, with only 1 reporting results (4.7%). Completed trials regarding vNOTES indicated fewer adverse events compared to laparoscopic surgery.
Conclusion: vNOTES appears promising, with evidence suggesting fewer postoperative complications than laparoscopic surgery. However, further research is needed to establish guidelines and assess the broader application of vNOTES in OB/GYN. Despite limited clinical trials, vNOTES may be beneficial for patients suitable for vaginal hysterectomy
| Original language | American English |
|---|---|
| Pages | 44 |
| State | Published - 13 Sep 2024 |
| Event | 2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health - Oklahoma State University College of Osteopathic Medicine at the Cherokee Nation, Tahlequah, United States Duration: 13 Sep 2024 → 13 Sep 2024 |
Conference
| Conference | 2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health |
|---|---|
| Abbreviated title | STRIDE 2024 |
| Country/Territory | United States |
| City | Tahlequah |
| Period | 13/09/24 → 13/09/24 |