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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 June 2021 |
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Main ID: |
NCT02731391 |
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Date of registration:
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28/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse
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Scientific title:
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Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02731391 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Shan Wang, doctor |
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Address:
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Telephone:
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Email:
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iao@pkuph.edu.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- Gestation;
- Inflammatory bowel disease;
- Slow transit constipation diagnosed by Colonic transit test;
- Unable to follow up.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bowel Symptoms
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Intervention(s)
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Procedure: Pelvic floor reconstruction(with or without mesh)
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Primary Outcome(s)
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change in the severity of intestinal symptoms
[Time Frame: baseline,1,3,6,12 months after operation.]
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change in the prevalence of bowel symptoms
[Time Frame: baseline,1,3,6,12 months after operation.]
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Secondary Outcome(s)
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change in the quality of life
[Time Frame: baseline,1,3,6,12 months after operation.]
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rectoanal inhibitory reflex recorded by anorectal manometry
[Time Frame: baseline and 12 months after operation]
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Rectal-Vaginal pressure interval during maximum Vasalva
[Time Frame: baseline and 6 months after operation]
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length of the high-pressure zone recorded by anorectal manometry
[Time Frame: baseline and 12 months after operation]
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Secondary ID(s)
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pkuph-0103969
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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