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Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

NCT05682989 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-04-05

No results posted yet for this study

Summary

This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

Conditions

  • Pelvic Organ Prolapse
  • Stage III and IV High Grade Pelvic Organ Prolapse

Interventions

PROCEDURE

Urodynamic investigations before and after a mesh surgery protocol.

Urodynamic investigations (The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min.

PROCEDURE

Urodynamic investigations before and after a robotic-assisted sacrocolpopexy protocol.

All surgeries were performed using a DaVinci robotic system (Intuitive® Surgical Inc., Sunnyvale, California,US) with standardized technique and materials. Patients were positioned in dorsal lithotomy and steep Trendelenburg position. Trocars were placed bilaterally, and an assistant port was placed laterally. The peritoneum was opened medial to the ureter to develop an avascular space. The mesh was placed on the posterior and anterior vaginal wall and fixed at the level of anterior longitudinal ligaments S1/S2 by sutures. An intraoperative clinical examination was performed to ensure the mesh was in a tension-free position.

PROCEDURE

Urodynamic investigations before and after a hysterectomy with trans-vaginal mesh repair

In summary, a vertical incision was made in the anterior vaginal wall to access the vesicovaginal space. The sacrospinous ligament was dissected, and an applicator was inserted and positioned over the SSL. The anchor was fixed to the SSL and the thread was attached to the mesh. The mesh was then adjusted in a tension-free manner, excess mesh was cut, and the incision was closed with suture.

Sponsors & Collaborators

  • Mackay Medical College

    lead OTHER

Principal Investigators

  • Hui-Hsuan Lau, M.D. · Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan

Eligibility

Min Age
30 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-01
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05682989 on ClinicalTrials.gov