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Lateral Suspension and Sacropexy for Pelvic Organ Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lateral suspension
sacropexy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Apical prolapse Stage 2-4 according to POP-Q system
  • Uterine preservation or after hysterectomy
  • Sexually active or not.

Exclusion Criteria:

  • Pregnancy or up to 6 months postpartum.
  • Current Urinary tract infection proved by urine analysis or urine culture.
  • Patient unfit for surgery.
  • Previous suspension operations.
  • Uncontrolled diabetic patients.
  • Urge incontinence.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lateral suspension

sacropexy

Arm Description

All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina

Our first passage is the peritoneum incision overlying the sacral promontory (L5-S1) to expose the anterior longitudinal ligament, which is the anchorage point of the mesh on the sacrum. We create a tunnel under the peritoneum on the right side through the cul-de-sac of Douglas till reach the cervix or vaginal cuff (after hysterectomy).

Outcomes

Primary Outcome Measures

rate of occurance of denovo stress urinary incontinence
number of patients developed new onset postoperative stress urinary incontinence
The rate of Improvement of urinary symptoms
Improvement of symptoms using Abramsc Development and psychometric evaluation of the International consultation on incontinence and Vaginal Symptoms Questionnaire maximum score:178, minimum score:0 high score means better outcome , low score means worse outcome

Secondary Outcome Measures

objective assessment of prolapse stage
improvement of POP-Q system postoperatively
assessment of sexual function
improvement of female sexual function index postoperatively

Full Information

First Posted
December 9, 2018
Last Updated
January 27, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03772691
Brief Title
Lateral Suspension and Sacropexy for Pelvic Organ Prolapse
Official Title
Lateral Suspension Versus Sacropexy for Treatment of Apical Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems all over the world. Pelvic organ prolapse (POP) is common and can be seen in up to 50% or more of parous women. The annual aggregated rate of associated surgery for pelvic organ prolapse is in the range of 10-30 per 10,000 women. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. Apical POP refers any descent of the cervix or the vaginal cuff scar(as after hysterectomy) below a point which is 2 cm less than the total vaginal length about the plane of the hymen. Apical POP is due to defect in apical support with damage to the cardinal and uterosacral ligaments. Apical pelvic organ prolapse is a common issue in our country with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births)
Detailed Description
By one estimate, the demand for health care services related to pelvic floor disorders will increase at twice the rate of the population itself . So we need adequate understanding of the best surgical method for treating apical POP which is accepted worldwide and also must be cost effective with least perioperative complications. Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse. In this technique, the mesh is fixed to the anterior longitudinal ligament at the sacral promontory. It is used either with uterine preservation (sacrohysteropexy) or after hysterectomy (sacrocolpopexy) for treatment of vault prolapse .However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . Also, despite that sacropexy provide good apical support, but the high prevalence of cystocele and urinary tract symptoms in patients reaches up to 8% . Consequently, it is not surprising that the majority of failures following sacrocolpopexy occur in the anterior compartment. Lateral suspension with mesh was first reported by Dubuisson in 1998 for the treatment of pelvic organ prolapse . The lateral suspension avoids both the risk of vascular injury and nerve damage of sacrocolpopexy with success rate up to 88% of cases.

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
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lateral suspension
Arm Type
Experimental
Arm Description
All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina
Arm Title
sacropexy
Arm Type
Active Comparator
Arm Description
Our first passage is the peritoneum incision overlying the sacral promontory (L5-S1) to expose the anterior longitudinal ligament, which is the anchorage point of the mesh on the sacrum. We create a tunnel under the peritoneum on the right side through the cul-de-sac of Douglas till reach the cervix or vaginal cuff (after hysterectomy).
Intervention Type
Procedure
Intervention Name(s)
lateral suspension
Intervention Description
• The vesico-vaginal space was found between the bladder and the anterior vaginal wall in the fascia plane. A polypropylene mesh (25 , 25 cm, Ethicon, Inc., Somerville, NJ) was cut to obtain two long arms (15-20 mm wide) and a rectangular piece (4-7 cm wide).
Intervention Type
Procedure
Intervention Name(s)
sacropexy
Intervention Description
• The mesh is fixed on the anterior longitudinal ligament of sacrum with separated number 1 prolene sutures. The other end of the mesh is passed through the peritoneal tunnel and fixed to the cervix using prolene 1 and vicryl o sutures.
Primary Outcome Measure Information:
Title
rate of occurance of denovo stress urinary incontinence
Description
number of patients developed new onset postoperative stress urinary incontinence
Time Frame
18 months
Title
The rate of Improvement of urinary symptoms
Description
Improvement of symptoms using Abramsc Development and psychometric evaluation of the International consultation on incontinence and Vaginal Symptoms Questionnaire maximum score:178, minimum score:0 high score means better outcome , low score means worse outcome
Time Frame
18 months
Secondary Outcome Measure Information:
Title
objective assessment of prolapse stage
Description
improvement of POP-Q system postoperatively
Time Frame
18 months
Title
assessment of sexual function
Description
improvement of female sexual function index postoperatively
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Apical prolapse Stage 2-4 according to POP-Q system Uterine preservation or after hysterectomy Sexually active or not. Exclusion Criteria: Pregnancy or up to 6 months postpartum. Current Urinary tract infection proved by urine analysis or urine culture. Patient unfit for surgery. Previous suspension operations. Uncontrolled diabetic patients. Urge incontinence.
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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Lateral Suspension and Sacropexy for Pelvic Organ Prolapse

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