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Войти в исследования Surgical endoscopy · 2026
Comparison of sexual function and postoperative recovery following V-NOTES versus laparoscopic bilateral tubal ligation and salpingectomy: a randomised controlled trial.
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Ada Onur, Dagli Uğurcan, Bilen Egehan, Bayram Emre, Sezen Didem, Inan Abdurrahman Hamdi
Аннотация
BACKGROUND: We compared sexual function and postoperative recovery between transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) and conventional laparoscopy in women undergoing bilateral tubal ligation or salpingectomy for sterilisation.
METHODS: We randomised 108 women equally to V-NOTES or laparoscopy. The primary outcome was change in total female sexual function Index (FSFI) score from baseline to 6 weeks and 6 months, analysed as two primary comparisons with Bonferroni adjustment. Secondary outcomes included FSFI domains, perioperative outcomes and complications. First intercourse was recorded at the 6-week visit.
CLINICALTRIALS: gov: NCT07637201 (retrospectively registered).
RESULTS: All participants completed both assessments. At 6 weeks, total FSFI changed by 0.90 (SD 1.97) after laparoscopy and - 4.01 (SD 1.43) after V-NOTES: difference - 4.91 (95% CI - 5.56 to - 4.25; adjusted P < 0.001). At 6 months, changes were 1.63 and 1.86, respectively: difference 0.23 (95% CI - 0.34 to 0.79; adjusted P = 0.855). All participants resumed intercourse before the 6-week assessment, at a median of 39 days after V-NOTES and 15 days after laparoscopy. The median interval from first intercourse to assessment, capped at 28 days, was 4 and 27 days, respectively. V-NOTES was associated with lower 6-h pain (median 4 versus 6), earlier discharge (27 versus 29 h) and longer operative time (70.0 versus 52.5 min; all adjusted P < 0.001). Three complications occurred, all after V-NOTES.
CONCLUSIONS: The lower 6-week FSFI score after V-NOTES reflects the combined effect of surgery and its routine postoperative course, including later resumption of intercourse. It cannot be attributed to the transvaginal route alone. No significant between-group difference in the change in total FSFI score was detected at 6 months; equivalence was not assessed. V-NOTES was associated with less early pain, modestly earlier discharge and longer surgery.
CLINICALTRIALS: gov Identifier: NCT07637201; first submitted 1 June 2026, first submitted with quality-control criteria met 5 June 2026, first posted 9 June 2026 (retrospectively registered, after recruitment had been completed).
METHODS: We randomised 108 women equally to V-NOTES or laparoscopy. The primary outcome was change in total female sexual function Index (FSFI) score from baseline to 6 weeks and 6 months, analysed as two primary comparisons with Bonferroni adjustment. Secondary outcomes included FSFI domains, perioperative outcomes and complications. First intercourse was recorded at the 6-week visit.
CLINICALTRIALS: gov: NCT07637201 (retrospectively registered).
RESULTS: All participants completed both assessments. At 6 weeks, total FSFI changed by 0.90 (SD 1.97) after laparoscopy and - 4.01 (SD 1.43) after V-NOTES: difference - 4.91 (95% CI - 5.56 to - 4.25; adjusted P < 0.001). At 6 months, changes were 1.63 and 1.86, respectively: difference 0.23 (95% CI - 0.34 to 0.79; adjusted P = 0.855). All participants resumed intercourse before the 6-week assessment, at a median of 39 days after V-NOTES and 15 days after laparoscopy. The median interval from first intercourse to assessment, capped at 28 days, was 4 and 27 days, respectively. V-NOTES was associated with lower 6-h pain (median 4 versus 6), earlier discharge (27 versus 29 h) and longer operative time (70.0 versus 52.5 min; all adjusted P < 0.001). Three complications occurred, all after V-NOTES.
CONCLUSIONS: The lower 6-week FSFI score after V-NOTES reflects the combined effect of surgery and its routine postoperative course, including later resumption of intercourse. It cannot be attributed to the transvaginal route alone. No significant between-group difference in the change in total FSFI score was detected at 6 months; equivalence was not assessed. V-NOTES was associated with less early pain, modestly earlier discharge and longer surgery.
CLINICALTRIALS: gov Identifier: NCT07637201; first submitted 1 June 2026, first submitted with quality-control criteria met 5 June 2026, first posted 9 June 2026 (retrospectively registered, after recruitment had been completed).