Vaginal Vault Native Tissue Suspension

NCT07517965 — Not applicable, Recruiting, 10 participants, Assiut University

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

RegistryNCT07517965
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment10 (Estimated)
SponsorAssiut University (Other)
ConditionsPelvic Organ Prolapse
InterventionsMackenrodt uterosacral double ligaments suspension (Procedure)
Datesstart 2026-06-03, primary completion 2027-04-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-04-08, last updated 2026-06-04
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Pelvic Organ Prolapse All trials of Mackenrodt uterosacral double ligaments suspension

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Suspension groupExperimentalProcedure: Mackenrodt uterosacral double ligaments suspension
  • 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

+Outcome measures

Primary outcomes

  • Pelvic organ prolapse Stage [3 months]: Increase stage means bad outcome Minimum: 0 , Maximum:4

+Eligibility

Sex: Female

Inclusion Criteria:

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

Exclusion Criteria:

* pregnacy or 6 months postpartum
* previous suspension surgery

+Locations (1)

FacilityCityCountryStatus
Women's Health HospitalAsyutEgyptRecruiting

+Investigators

  • Women H Hospital, Principal investigator, Women's health hospital