NCT07517965

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

April 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 3, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 4, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 2, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Vault SuspensionMackenrodt ligamentsUterosacral ligaments

Outcome Measures

Primary Outcomes (1)

  • Pelvic organ prolapse Stage

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

    3 months

Study Arms (1)

Suspension group

EXPERIMENTAL
Procedure: Mackenrodt uterosacral double ligaments suspension

Interventions

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

Suspension group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnacy or 6 months postpartum
  • previous suspension surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Women H Hospital

    Women's health hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer obstetric and gynecology, Specialist Urogynecology

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 8, 2026

Study Start

June 3, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 4, 2026

Record last verified: 2026-04

Locations