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NCT Number: NCT07517965

Vaginal Vault Native Tissue Suspension

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

Recruiting

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnacy or 6 months postpartum
  • previous suspension surgery

Treatment and study plan

Mackenrodt uterosacral double ligaments suspension

Procedure

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 approximately 1 cm distal to its sacral origin, in order to avoid entrapment of S3 nerve root. The suture is then passed through the mid portion of the ligament in one or two bites and secured to the posterior vaginal wall.hese steps are repeated in the contralateral ligament. Manchester procedure: Vicryl 1 suture will pass through Mackenrodt ligament and then fixed to the anterior vaginal wall. The suture is repeated on the opposite side ,so both Mackenrodt ligaments will be fixed th anterior vagina

Primary outcomes

  1. Pelvic organ prolapse Stage

    Time frame: 3 months

    Increase stage means bad outcome Minimum: 0 , Maximum:4

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Gamal

CONTACT

[email protected]

+20882312388

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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