Back to results

Risk Factors for Recurrence After Pelvic Reconstruction

Primary Purpose

Pelvic Organ Prolapse

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

herniamesh

biological graft

About this trial

This is an interventional health services research trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Vaginal mesh, biological graft, Recurrence

Eligibility Criteria

52 Years - 76 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

group A

group B

Arm Description

accepted herniamesh mesh

accepted biological graft of cook

Outcomes

Primary Outcome Measures

recurrence

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

Secondary Outcome Measures

perioperative complications

perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)

Full Information

NCT ID

NCT03457883

First Posted

February 26, 2018

Last Updated

March 6, 2018

Sponsor

Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03457883

Brief Title

Risk Factors for Recurrence After Pelvic Reconstruction

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse, Vaginal mesh, biological graft, Recurrence

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

232 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Experimental

Arm Description

accepted herniamesh mesh

Arm Title

group B

Arm Type

Experimental

Arm Description

accepted biological graft of cook

Intervention Type

Device

Intervention Name(s)

herniamesh

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

biological graft

Intervention Description

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 Outcome Measure Information:

Title

recurrence

Description

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

Time Frame

at 12 months after surgery

Secondary Outcome Measure Information:

Title

perioperative complications

Description

perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)

Time Frame

12 months after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

52 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility 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;

12. IPD Sharing Statement

Learn more about this trial

Risk Factors for Recurrence After Pelvic Reconstruction

We'll reach out to this number within 24 hrs