Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Hysteropexy

• Registration Number: NCT04850365
• Lead Sponsor: Ain Shams University

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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal sacrospinous hysteropexy	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;
Abdominal sacral hysteropexy	Hysteropexy	The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.

Primary Outcome Measures

Name	Time	Method
Operative time	intraoperative	Operative time will be recorded starting from skin incision.

Secondary Outcome Measures

Name	Time	Method
a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q).	From 6 months to 1 year follow up	The patients will be followed for recurrence of the symptoms and the degree of descent.
b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0	From 6 months to 1 year follow up	It will be used to assess the safety and tolerability to the procedure.

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt