Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hysteropexy
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Symptomatic apical descent stage II or more.
- Eligible for both surgical procedures
- No uterine or cervical pathology.
- Able to consent to participate in the trial.
Exclusion Criteria:
- Women with contraindication to any surgical procedures.
- Women with previous apical prolapse surgery.
- One of the two surgical approaches is not feasible.
- Women with concomitant surgical procedures apart from correction of the prolapse.
- Women who prefer to have hysterectomy.
Sites / Locations
- Ain Shams universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Abdominal sacral hysteropexy
Vaginal sacrospinous hysteropexy
Arm Description
The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.
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;
Outcomes
Primary Outcome Measures
Operative time
Operative time will be recorded starting from skin incision.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04850365
Brief Title
Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy
Official Title
Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abdominal sacral hysteropexy
Arm Type
Other
Arm Description
The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.
Arm Title
Vaginal sacrospinous hysteropexy
Arm Type
Other
Arm 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;
Intervention Type
Procedure
Intervention Name(s)
Hysteropexy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Operative time
Description
Operative time will be recorded starting from skin incision.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q).
Description
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
Title
b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0
Description
It will be used to assess the safety and tolerability to the procedure.
Time Frame
From 6 months to 1 year follow up
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Symptomatic apical descent stage II or more.
Eligible for both surgical procedures
No uterine or cervical pathology.
Able to consent to participate in the trial.
Exclusion Criteria:
Women with contraindication to any surgical procedures.
Women with previous apical prolapse surgery.
One of the two surgical approaches is not feasible.
Women with concomitant surgical procedures apart from correction of the prolapse.
Women who prefer to have hysterectomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa Ragab Mady
Phone
0201011431780
Email
dr.asmaa.r.mady@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Ragab Mady
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams university
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mady
Phone
01011431780
Email
dr.asmaa.r.mady@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy
We'll reach out to this number within 24 hrs