Vaginally Assisted Laparoscopic Sacropolpopexy

NCT04332315 | Completed

• 1 other identifier: VALS01
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction and Hypothesis: Vaginally assisted laparoscopic sacrocolpopexy (VALS), which is a combined surgical approach where a vaginal hysterectomy is initially performed, followed by transvaginal placement of synthetic mesh and laparoscopic suspension, can be an alternative to overcome the dissection, suturing limitations of laparoscopic sacrocolpopexy. The aim of this study was to compare the middle term anatomic outcomes, complication rates, and operative times of patients with uterovaginal prolapse undergoing VALS with those of women undergoing abdominal sacrocolpopexy. Methods: This is a prospective cohort study that evaluates operation times, anesthesia times, estimated blood loss, middle term outcomes, perioperative and postoperative complications. We compared the results of 47 women who had the VALS to that of 32 abdominal sacrocolpopexy.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Middle term failure

  stage II or greater apical prolapse, with the leading edge of the C point to 1 cm on either side of the introitus that requires surgical treatment

  2 years

Secondary Outcomes (2)

• anatomic failure

  2 years

• subjective failure

  2 years

Study Arms (2)

VALS

ACTIVE COMPARATOR

Vaginally asissted laparoscopic sacrocolpopexy

Procedure: Vaginally assisted laparoscopic sacrocolpopexy

AS

ACTIVE COMPARATOR

Abdominal Sacrocolpopexy

Procedure: Vaginally assisted laparoscopic sacrocolpopexy

Interventions

Vaginally assisted laparoscopic sacrocolpopexy PROCEDURE

The VALS procedure consists of two steps. First, vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy performed, anterior vaginal wall dissected up to bladder neck starting from initial vaginal incision, posterior vaginal wall dissected from rectum starting from initial vaginal incision up to distal third of posterior vaginal wall.The free arms of fixed meshes are introduced to the peritoneal cavity and the vaginal vault is closed with absorbable polyglactin suture. laparoscopy phase was performed with one intraumbilical (10 mm), 3 lateral abdominal (5 mm) trocars. Two mesh strips fixated to anterior longitudinal ligament of the sacrum with two separate no: 1 polypropylene sutures without tension. AS was performed via Pfannenstiel incision after total or subtotal abdominal hysterectomy

Also known as: Abdominal sacrocolpopexy

AS; VALS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Women suffering from prolapse and who desired surgical correction of their prolapse were included to trial.

You may not qualify if:

• \- Fertile women who have not completed their family and women with previous POP surgery, POP stage ≤ 2 and women who prefer conservative management or uterus sparing surgery were excluded from the study.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: July 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: March 30, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-03