VVPST
Vaginal Natural Orifice Transluminal Surgery High Uterosacral Ligament Suspension Versus Laparoscopic Lateral Suspension in the Management of Vaginal Vault Prolapse: Initial Experience in a Single Center With a Median-term Follow-up
Sponsor study identifier
observational
64
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
June 30, 2022
Actual (reported)Study Completion
September 30, 2024
Actual (reported)Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)June 30, 2022
Actual (reported)September 30, 2024
Actual (reported)January 11, 2025
Actual (reported)January 24, 2025
Actual (reported)Anatomical and functional outcomes
Evaluation of Pelvic organ prolapse quantification (POP-Q) scores before and after surgeries. Clinical assessment of the pelvic floor was performed by a gynecologist experienced in the evaluation of pelvic organ prolapse, while patients were in the supine lithotomy position. In the POP-Q, nine measurement points are assessed during the maximal Valsalva maneuver, except for the transvaginal length (TVL), measured at rest. Only the measurements of POP-Q points Ba, C, Bp were used to compare preoperative and postoperative evaluation. Ba is the most descended edge on the anterior vaginal wall, C represents either the most distal edge of the cervix or the leading edge of the vaginal vault, Bp is the most descended edge on the posterior vagina wall. Measurements in centimeters relative to the hymenal remnants were used in the analysis.
14-30 months
Requirement of reoperation
Number and rate of women requiring subsequent surgery for pelvic organ prolapse following the studied surgeries.
14-30 months
Subjective recurrence
The presence of bulging symptoms
14-30 months
Transition of patient condition after surgery
6 months
Sexual Function
6 months
Change in quality of life
6 months
Change of sexual function
6 months
Parameters regarding surgery
14-30 months
Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension.
Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent laparoscopic lateral suspension.
Following the entry into the peritoneal cavity via apical colpotomy, a transvaginal retractor was inserted through the vaginal vault and the vaginal access platform was established. The ureters and uterosacral ligaments (USL) were identified via laparoscopic view. Bilateral nonabsorbable sutures were placed by the intermediate portions of the USL at the level of the ischial spines making up a total of 4 stitches (Figure 1). Then, the sutures were slightly weighed to verify proper placement. Then, the V-notes platform was removed and the peritoneum was closed. The aforementioned sutures were fixed to the ipsilateral cardinal ligament stump and the pubocervical fascia on the anterior wall. Finally, the previously mentioned nonabsorbable sutures were attached to the vaginal cuff and tied. Routine postoperative cystoscopy was performed.
Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension
Arzu Bilge Tekin
Istanbul, Sancaktepe, 34785, Turkey (Türkiye)
Lu Z, Chen Y, Wang X, Li J, Hua K, Hu C. Transvaginal natural orifice transluminal endoscopic surgery for uterosacral ligament suspension: pilot study of 35 cases of severe pelvic organ prolapse. BMC Surg. 2021 Jun 8;21(1):286. doi: 10.1186/s12893-021-01280-6.
Lowenstein L, Baekelandt J, Paz Y, Lauterbach R, Matanes E. Transvaginal Natural Orifice Transluminal Endoscopic Hysterectomy and Apical Suspension of the Vaginal Cuff to the Uterosacral Ligament. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1015. doi: 10.1016/j.jmig.2019.04.007. Epub 2019 Apr 10.
Arzu B Tekin
SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH
64 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2025
First Posted
January 24, 2025
Study Start
January 1, 2019
Actual (reported)The polypropylene mesh used had a width of 2.5 cm and a length of 25 cm. The vaginal cuff was suspended. Blunt dissection was applied to develop vesicovaginal and rectovaginal spaces. The middle part of the mesh was placed flatly in the vesicovaginal space, and fixed with non-absorbable sutures. An atraumatic laparoscopic instrument was inserted through skin incisions of approximately 2-3 mm approximately 3 cm above and 4 cm lateral to the anterior superior iliac spine, followed by perforation only of the aponeurosis of the external oblique muscle and retroperitoneal advancement of the instrument through the lateral abdominal wall. Under laparoscopic visualization, the instrument moved through the bilateral tension-free retroperitoneal tunnels created. The lateral arms of the mesh were secured bilaterally to the aponeurosis of the external oblique muscle and behind the anterior superior iliac spine. Finally, the peritoneum was closed.
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Dubuisson J, Veit-Rubin N, Bouquet de Joliniere J, Dubuisson JB. Laparoscopic Lateral Suspension: Benefits of a Cross-shaped Mesh to Treat Difficult Vaginal Vault Prolapse. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):672. doi: 10.1016/j.jmig.2016.01.028. Epub 2016 Feb 8.
Primary Completion
June 30, 2022
Actual (reported)Study Completion
September 30, 2024
Actual (reported)Last Updated
January 24, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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