NCT03457883

Risk Factors for Recurrence After Pelvic Reconstruction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 52 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-06-01
• Completion: 2017-12-01
• First posted: 2018-03-08
• Last updated: 2018-03-08