Risk Factors for Recurrence After Pelvic Reconstruction

• ClinicalTrials.gov Identifier: NCT03457883
• Recruitment Status: Completed
• First Posted: March 8, 2018
• Last Update Posted: March 8, 2018
• Sponsor: Nanjing Medical University
• Information provided by (Responsible Party): Xirong Guo, Nanjing Medical University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pelvic Organ Prolapse	Device: herniamesh; Device: biological graft	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 232 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: group A; accepted herniamesh mesh	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.
Experimental: group B; accepted biological graft of cook	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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 52 Years to 76 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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;

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Xirong Guo, Vice President of Nanjing maternity and child Health Care Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03457883
• Other Study ID Numbers: NMU-2017323
• First Posted: March 8, 2018
• Last Update Posted: March 8, 2018
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xirong Guo, Nanjing Medical University:

Pelvic organ prolapse; Vaginal mesh; biological graft; Recurrence

Additional relevant MeSH terms:

Recurrence; Prolapse; Pelvic Organ Prolapse; Disease Attributes; Pathologic Processes; Pathological Conditions, Anatomical