Lateral Suspension and Sacropexy for Pelvic Organ Prolapse

NCT ID: NCT03772691

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-01

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lateral suspension

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

Group Type: EXPERIMENTAL

lateral suspension

Intervention Type: PROCEDURE

• 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

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).

Group Type: ACTIVE_COMPARATOR

sacropexy

Intervention Type: PROCEDURE

• 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Gamal M.fekry

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

References

Sayed E, Mitwally A, Abdelmagied A, Fetih A, Fekry M. Transperineal Ultrasound Evaluation of Bladder Parameters in Patients with Apical Prolapse Undergoing Lateral Suspension or Sacropexy. J Obstet Gynaecol India. 2024 Apr;74(2):170-175. doi: 10.1007/s13224-023-01912-2. Epub 2023 Dec 19.

Reference Type: DERIVED

PMID: 38707876 (View on PubMed)

Other Identifiers

LSS

Identifier Type: -

Identifier Source: org_study_id