Risk Factors for Recurrence After Pelvic Reconstruction

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457883
• Other study ID #: NMU-2017323
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 6, 2018
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 52 Years to 76 Years

Eligibility

Inclusion Criteria:

242 postmenopausal patients with primary prolapse of the anterior vaginal wall or concomitant uterine prolapse,that was stage ? 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;

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	Recurrence was defined as a POP-quantification system stage =IIb or any symptomatic prolapse.	at 12 months after surgery
Secondary	perioperative complications	perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)	12 months after surgery