Vaginal Vault Prolapse Surgical Treatment

NCT ID: NCT06792331

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-09-30

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.

Conditions

Vaginal Vault Prolapse; Pelvic Floor Prolapse

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

vNOTES high uterosacral ligament suspension

Intervention Type: 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 laparoscopic lateral suspension.

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

Laparoscopic lateral suspension

Intervention Type: 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.

Interventions

vNOTES high uterosacral ligament 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.

Intervention Type: PROCEDURE

Laparoscopic lateral suspension

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arzu Bilge Tekin

Assoc. Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu B Tekin

Role: STUDY_CHAIR

SBÜ Sancaktepe Şehit Prof Dr İlhan Varank EAH

Locations

Arzu Bilge Tekin

Istanbul, Sancaktepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34103032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30980991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26867700 (View on PubMed)

Other Identifiers

VVPST

Identifier Type: -

Identifier Source: org_study_id