Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

NCT04850365 | Unknown

• 1 other identifier: Abdovagpexy
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Operative time

  Operative time will be recorded starting from skin incision.

  intraoperative

Secondary Outcomes (2)

• a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q).

  From 6 months to 1 year follow up

• b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0

  From 6 months to 1 year follow up

Study Arms (2)

Abdominal sacral hysteropexy

OTHER

The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.

Procedure: Hysteropexy

Vaginal sacrospinous hysteropexy

OTHER

This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion. The outcomes will be obtained as follow;

Procedure: Hysteropexy

Interventions

Hysteropexy PROCEDURE

Abdominal Sacral cervicopexy: The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh. Vaginal Sacrospinous cervicopexy: This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion.

Abdominal sacral hysteropexy; Vaginal sacrospinous hysteropexy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Symptomatic apical descent stage II or more.
• Eligible for both surgical procedures
• No uterine or cervical pathology.
• Able to consent to participate in the trial.

You may not qualify if:

• Women with contraindication to any surgical procedures.
• Women with previous apical prolapse surgery.
• One of the two surgical approaches is not feasible.
• Women with concomitant surgical procedures apart from correction of the prolapse.
• Women who prefer to have hysterectomy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Asmaa Ragab Mady

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Ragab Mady

CONTACT

0201011431780; dr.asmaa.r.mady@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 20, 2021
• Study Start: January 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

EG (1)