Lateral Suspension and Sacropexy for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Lateral Suspension Versus Sacropexy for Treatment of Apical Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772691
• Other study ID #: LSS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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).
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of occurance of denovo stress urinary incontinence	number of patients developed new onset postoperative stress urinary incontinence	18 months
Primary	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	18 months
Secondary	objective assessment of prolapse stage	improvement of POP-Q system postoperatively	18 months
Secondary	assessment of sexual function	improvement of female sexual function index postoperatively	18 months