Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Pelvic Organ Prolapse Clinical Trial

Official title:

Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850365
• Other study ID #: Abdovagpexy
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 2022

Study information

• Verified date: February 2022
• Source: Ain Shams University
• Contact: Asmaa Ragab Mady
• Phone: 0201011431780
• Email: dr.asmaa.r.mady[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time will be recorded starting from skin incision.	intraoperative
Secondary	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.	From 6 months to 1 year follow up
Secondary	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.	From 6 months to 1 year follow up