Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Hysteropexy

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa Ragab Mady; Phone Number: 0201011431780; Email: dr.asmaa.r.mady@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Ain shams university
    • Contact: Mady; Phone Number: 01011431780; Email: dr.asmaa.r.mady@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Abdominal sacral hysteropexy; The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.	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.
OTHER: 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;	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time will be recorded starting from skin incision.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Asmaa Ragab Mady, Ain shams university

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (ACTUAL): April 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Abdovagpexy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No