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Recruiting NCT07517965

Vaginal Vault Native Tissue Suspension

No phase Interventional Pelvic Organ Prolapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mackenrodt uterosacral double ligaments suspension.
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of a Novel Mackenrodt Uterosacral Double Ligaments Vault Suspension for Treatment of Pelvic Organ Prolapse

Overview

Vaginal vault suspension at time of abdominal hysterectomy using Mackenrodt and uterosacral ligaments.

Detailed description

Hysterectomy is one of the most frequently performed gynecological procedures. Hysterectomy remains an important treatment option for a number of benign and malignant indication. Several other studies have shown that hysterectomy independently increased the incidence of subsequent POP, especially when hysterectomy was performed for POP indication. Some studies even have shown that women after hysterectomy were 50% more likely to report symptoms of pelvic floor disorders. With regard to prolapse of the vaginal apex in particular, it has been hypothesized that the "disruption of the cardinaluterosacral ligament complex" during hysterectomy decreases vaginal support. Therefore, adequate support for the vaginal apex would be an essential component to reduce the incidence of post-hysterectomy apical POP. Our study aims to evaluate novel Mackenrodt Uterosacral double ligament vault suspension technique as a treatment option for pelvic prolapse during total abdominal hysterectomy.

Interventions

  • Procedure Mackenrodt uterosacral double ligaments suspension
    Total hysterectomy will be performed and vaginal vault will be closed with absorbable vicryl sutures The pelvis is then inspected and both uterosacral ligaments and ureters are identified. The proximal part of the mid-portion of each ligament is grasped and put under tension. In case of proximity to the ureter, a peritoneal release incision is performed to avoid kinking of the ipsilateral ureter. A Vicryl 1/0 suture is then used and passed through the proximal portion of the ligament approximate

Primary outcome measures

  • Pelvic organ prolapse Stage [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • women undergoing hysterectomy
  • Stage 1 or more pelvic organ prolapse

Exclusion criteria

  • pregnacy or 6 months postpartum
  • previous suspension surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Women's Health Hospital — Asyut

Identifiers

NCT: NCT07517965 · MUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗