Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Ain Shams University

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Hysteropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT04850365

Abdovagpexy

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Abdominal sacral hysteropexy

Other group

Description:

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

Treatment:

Procedure: Hysteropexy

Vaginal sacrospinous hysteropexy

Other group

Description:

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;

Treatment:

Procedure: Hysteropexy