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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Anatomical and functional outcomes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Anatomical and functional outcomes
Time Frame: 14-30 months
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.
Requirement of reoperation
Time Frame: 14-30 months
Number and rate of women requiring subsequent surgery for pelvic organ prolapse following the studied surgeries.
Subjective recurrence
Time Frame: 14-30 months
The presence of bulging symptoms
Secondary Outcomes
- 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)
Investigators
Arzu Bilge Tekin
Assoc. Prof. MD
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital