Risk Factors for Recurrence After Pelvic Reconstruction

Overview

232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, including group A(accepted herniamesh polypropylene mesh, 117 patients);group B (underwent biological graft of cook,115 patients);follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

Full Title of Study: “Risk Factors for Recurrence After Pelvic Reconstruction of Pelvic Organ Prolapse:1 Year Follow-up in Patients Implanted Hernia Mesh and Biological Graft”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2016

Detailed Description

We prospectively study a total of 232 women who underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, the patients into two groups :group A was accepted herniamesh polypropylene mesh(117);group B underwent biological graft of cook(115);Each patient underwent an interview that included a POP-Q which was quantified according to the Pelvic Organ Prolapse Quantitation (POPQ) system;follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

Interventions

  • Device: herniamesh
    • Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.
  • Device: biological graft
    • Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.

Arms, Groups and Cohorts

  • Experimental: group A
    • accepted herniamesh mesh
  • Experimental: group B
    • accepted biological graft of cook

Clinical Trial Outcome Measures

Primary Measures

  • recurrence
    • Time Frame: at 12 months after surgery
    • Recurrence was defined as a POP-quantification system stage ≥IIb or any symptomatic prolapse.

Secondary Measures

  • perioperative complications
    • Time Frame: 12 months after surgery
    • perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)

Participating in This Clinical Trial

Inclusion Criteria

242 postmenopausal patients with primary prolapse of the anterior vaginal wall or concomitant uterine prolapse,that was stage Ⅲ or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system). Exclusion Criteria:

pelvic floor repair surgery history and recurrent patients ; pelvic cancer and radiation to the pelvic area in the previous 6 months; simple uterine prolapse; combined with severe stress urinary incontinence or overactive bladder (OAB); local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position) ; vaginal bleeding; infection; coagulation disorders; uncontrolled hypertension and diabetes mellitus;

Gender Eligibility: Female

Minimum Age: 52 Years

Maximum Age: 76 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xirong Guo, Vice President of Nanjing maternity and child Health Care Hospital – Nanjing Medical University

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