NCT02731391

Brief Summary

To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

6 years

First QC Date

January 28, 2016

Last Update Submit

May 26, 2021

Conditions

Bowel Symptoms

Outcome Measures

Primary Outcomes (2)

  • change in the prevalence of bowel symptoms

    baseline,1,3,6,12 months after operation.

  • change in the severity of intestinal symptoms

    assessed by Birmingham Bowel and Urinary Symptoms Questionnaire

    baseline,1,3,6,12 months after operation.

Secondary Outcomes (4)

  • change in the quality of life

    baseline,1,3,6,12 months after operation.

  • length of the high-pressure zone recorded by anorectal manometry

    baseline and 12 months after operation

  • rectoanal inhibitory reflex recorded by anorectal manometry

    baseline and 12 months after operation

  • Rectal-Vaginal pressure interval during maximum Vasalva

    baseline and 6 months after operation

Study Arms (2)

Mesh repairment

EXPERIMENTAL

patients undergoing pelvic floor Reconstruction using mesh

Procedure: Pelvic floor reconstruction（with or without mesh）

Tradition Neoplasty

ACTIVE COMPARATOR

patients undergoing traditional surgical approaches

Procedure: Pelvic floor reconstruction（with or without mesh）

Interventions

Pelvic floor reconstruction（with or without mesh）PROCEDURE
Mesh repairmentTradition Neoplasty

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with stage\>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

You may not qualify if:

  • Gestation；
  • Inflammatory bowel disease；
  • Slow transit constipation diagnosed by Colonic transit test；
  • Unable to follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 28, 2016

First Posted

April 7, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations

CN(1)