Vaginal Vault Prolapse Surgical Treatment

NCT06792331 | Completed

• 1 other identifier: VVPST
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Vault Prolapse; Pelvic Floor Prolapse

Keywords

Vaginal vault prolapse; vNOTES; high uterosacral ligament suspension; lateral suspension; laparoscopy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Women with vNOTES high uterosacral ligament suspension

Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent vNOTES high uterosacral ligament suspension and laparoscopic lateral suspension.

Procedure: vNOTES high uterosacral ligament suspension

Women with laparoscopic lateral suspension.

Symptomatic women aged 40-80 years old with ≥ stage 2 vault prolapse who underwent laparoscopic lateral suspension.

Procedure: Laparoscopic lateral suspension

Interventions

vNOTES high uterosacral ligament suspension PROCEDURE

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.

Women with vNOTES high uterosacral ligament suspension

Laparoscopic lateral suspension PROCEDURE

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.

Women with laparoscopic lateral suspension.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Women with vaginal vault prolapse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Women with vaginal vault prolapse

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Arzu Bilge Tekin

Istanbul, Sancaktepe, 34785, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 34103032 BACKGROUND

• 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.

  PMID: 30980991 BACKGROUND

• 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.

  PMID: 26867700 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Arzu B Tekin

  SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 24, 2025
• Study Start: January 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

TU (1)