Lateral Suspension and Sacropexy for Pelvic Organ Prolapse

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03772691
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
35
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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)

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: lateral suspension
  • Procedure: sacropexy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lateral Suspension Versus Sacropexy for Treatment of Apical Pelvic Organ Prolapse
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: lateral suspension

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

Procedure: lateral suspension
• 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).

Active Comparator: sacropexy

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).

Procedure: sacropexy
• 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.

Outcome Measures

Primary Outcome Measures

  1. rate of occurance of denovo stress urinary incontinence [18 months]

    number of patients developed new onset postoperative stress urinary incontinence

  2. The rate of Improvement of urinary symptoms [18 months]

    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

  1. objective assessment of prolapse stage [18 months]

    improvement of POP-Q system postoperatively

  2. assessment of sexual function [18 months]

    improvement of female sexual function index postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Assiut UniversityAssiutEgypt71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Gamal M.fekry, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03772691
Other Study ID Numbers:
  • LSS
First Posted:
Dec 11, 2018
Last Update Posted:
Feb 7, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022