Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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According to Cochrane group trials , abdominal approaches centered on sacral colpopexy is associated with lower risk of awareness of prolapse, repeat surgery for prolapse and dyspareunia than a variety of vaginal interventions. However, these trials weren't statistically significant and have focused on the effects in terms of anatomy and lacked the effect on functional outcomes, the quality of life, perioperative complications and the operative duration.

In this study, We hypothesize that prolonged operative duration will be associated with a greater risk of developing complications and so may guide us to a minimally invasive approach with better functional outcomes.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abdominal sacral hysteropexy

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

Group Type OTHER

Hysteropexy

Intervention Type 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.

Vaginal sacrospinous hysteropexy

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;

Group Type OTHER

Hysteropexy

Intervention Type 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.

Interventions

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Hysteropexy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Symptomatic apical descent stage II or more.
2. Eligible for both surgical procedures
3. No uterine or cervical pathology.
4. Able to consent to participate in the trial.

Exclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No