NCT03832543

Brief Summary

Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff prolapse. Methods / Technique : Forty patients with second and third-stage uterine prolapse who were operated were included in the study. During routine vaginal hysterectomy procedure performed on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and round ligaments which are the last-bites have been sutured and knotted, these ligaments were marked with 4-distinct clemps to make the right and left, upper and lower separation. After vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff tissue was stretched to the apical line.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

February 2, 2019

Last Update Submit

February 6, 2019

Conditions

Keywords

Vaginal Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative vaginal cuff prolapse

    During two years follow up after sugery if there is vaginal cuff prolapse or not. The measurement of the vaginal cuff distance to the hymenal ring with a calculator. The units were centimeter

    2 years

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details40-75 years old
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stage 2 or 3 uterin prolapse who need surgery

You may qualify if:

  • Stage 2 or 3 uterin prolapse

You may not qualify if:

  • contrandication for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof Kerem Doga Seckin

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 6, 2019

Study Start

April 1, 2016

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share