Bowel Symptoms Clinical Trial
Official title:
Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse
NCT number | NCT02731391 |
Other study ID # | pkuph-0103969 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | May 2022 |
Verified date | May 2021 |
Source | Peking University People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in the prevalence of bowel symptoms | baseline,1,3,6,12 months after operation. | ||
Primary | change in the severity of intestinal symptoms | assessed by Birmingham Bowel and Urinary Symptoms Questionnaire | baseline,1,3,6,12 months after operation. | |
Secondary | change in the quality of life | assessed by international consultation on incontinence questionnaire short form | baseline,1,3,6,12 months after operation. | |
Secondary | length of the high-pressure zone recorded by anorectal manometry | baseline and 12 months after operation | ||
Secondary | rectoanal inhibitory reflex recorded by anorectal manometry | baseline and 12 months after operation | ||
Secondary | Rectal-Vaginal pressure interval during maximum Vasalva | Measured by Peritron manometer | baseline and 6 months after operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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