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Vaginally Assisted Laparoscopic Sacropolpopexy

NCT04332315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-04-02

No results posted yet for this study

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

Interventions

PROCEDURE

Vaginally assisted laparoscopic sacrocolpopexy

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

Sponsors & Collaborators

  • Bezmialem Vakif University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2020-02-01
Completion
2020-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04332315 on ClinicalTrials.gov