Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Ain Shams University70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

HysteropexyPROCEDURE

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams university

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Operative time

Operative time will be recorded starting from skin incision.

Time frame: intraoperative

Secondary Outcomes

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

The patients will be followed for recurrence of the symptoms and the degree of descent.

Time frame: From 6 months to 1 year follow up

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

It will be used to assess the safety and tolerability to the procedure.

Time frame: From 6 months to 1 year follow up

Central Contacts

Asmaa Ragab Mady

CONTACT

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

Data from ClinicalTrials.gov

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