Clinical trial NCT06792331: Vaginal Vault Prolapse Surgical Treatment
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Vault Prolapse
Pelvic Floor Prolapse
Keywords: Vaginal vault prolapse
vNOTES
high uterosacral ligament suspension
lateral suspension
laparoscopy
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension

Brief summary: 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.

Detailed description: Hysterectomy is one of the common surgical procedures in current gynecology practice and is a risk factor for vault prolapse. 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. Lack of incision pain, better cosmetic results, and direct visualization of important structures such as the rectum and ureter that cannot be obtained with the traditional transvaginal approach are important advantages of vNOTES approach.

Eligibility criteria: Inclusion Criteria:

* Women with vaginal vault prolapse

Exclusion Criteria:

* Women who have previously undergone surgical treatment for pelvic organ prolapse
* Women who needed additional surgery due to anterior or posterior prolapse or stress incontinence
* Pelvic inflammatory disease
* Suspected gynecological malignancy
* Rectovaginal endometriosis
* obliterated rectovaginal space detected on pelvic examination.

Primary outcomes:
measure: Anatomical and functional outcomes
timeFrame: 14-30 months
measure: Requirement of reoperation
timeFrame: 14-30 months
measure: Subjective recurrence
timeFrame: 14-30 months
Secondary outcomes:
measure: Transition of patient condition after surgery
timeFrame: 6 months
measure: Sexual Function
timeFrame: 6 months
measure: Change in quality of life
timeFrame: 6 months
measure: Change of sexual function
timeFrame: 6 months
measure: Parameters regarding surgery
timeFrame: 14-30 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Arzu Bilge Tekin
state: Sancaktepe
Study officials:
affiliation: SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH
name: Arzu B Tekin
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.