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OpenTrials
Completed

NCT Number: NCT03457883

Risk Factors for Recurrence After Pelvic Reconstruction

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.

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Key information

Age range

52 year–76 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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.

Primary outcomes

  1. recurrence

    Time frame: at 12 months after surgery

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 8, 2018
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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