Modified Uterosacral Ligament Suspension in Vaginal Hysterectomy

Vault Prolapse, Vaginal Clinical Trial

Official title:

Modified Extraperitoneal Uterosacral Ligament Suspension in Preventing Cuff Prolapse Risk After Vaginal Hysterectomy; 4 Clamp Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832543
• Other study ID #: 0651603
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stage 2 or 3 uterin prolapse

Exclusion Criteria:

• contrandication for surgery

Related Conditions & MeSH terms

• Modified Extraperitoneal Uterosacral Ligament Suspension
• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse
• Vault Prolapse, Vaginal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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