Risk Factors for Recurrence After Pelvic Reconstruction

NCT03457883 | Completed DMC

• 1 other identifier: NMU-2017323
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Vaginal mesh; biological graft; Recurrence

Outcome Measures

Primary Outcomes (1)

• recurrence

  Recurrence was defined as a POP-quantification system stage ≥IIb or any symptomatic prolapse.

  at 12 months after surgery

Secondary Outcomes (1)

• perioperative complications

  12 months after surgery

Study Arms (2)

group A

EXPERIMENTAL

accepted herniamesh mesh

Device: herniamesh

group B

EXPERIMENTAL

accepted biological graft of cook

Device: biological graft

Interventions

herniamesh DEVICE

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.

group A

biological graft DEVICE

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.

group B

Eligibility Criteria

• Age: 52 Years - 76 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing Medical University: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse; Recurrence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Nanjing maternity and child Health Care Hospital

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 8, 2018
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-02