An interventional study of lateral suspension and sacropexy in Pelvic Organ Prolapse, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-07.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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)
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.
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Exclusion Criteria:
All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina
Procedure: lateral suspension
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 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).
• 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.
rate of occurance of denovo stress urinary incontinence
number of patients developed new onset postoperative stress urinary incontinence
Time frame: 18 months
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
Time frame: 18 months
objective assessment of prolapse stage
improvement of POP-Q system postoperatively
Time frame: 18 months
assessment of sexual function
improvement of female sexual function index postoperatively
Time frame: 18 months
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Assiut University