Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT03944720
Eligibility Criteria:
Inclusion Criteria:
* Women
* Older than 18 year old
* Symptoms of obstructed defecation associated to a rectocele with an indication for surgery according to the following criteria:
1. Symptoms of obstructed defecation according to Rome III criteria: straining, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, and/or manual manoeuvres to facilitate defecation at least in 25% of defecations for the last 3 months
2. Incomplete emptying of the rectocele on a defecography
3. Failure of conservative treatment including dietary advice and laxatives, with persisting symptoms of obstructive defecation
4. Recto-rectal intussusception may coexist on defecography (grade I and II of Oxford Prolapse Grading System)
5. Non-obstructive enterocele may coexist on defecography (type A enterocele: the small bowel descends to puboccoccygeal line (PCL) during straining and returns to PCL at the end of the straining attempt without compressing the rectal ampulla or compressing it from above with no obstruction)
6. Absence of anal sphincter dyssynergia on anorectal manometry, or successful rehabilitation after biofeedback in the case of previous dyssynergia
* Ability to understand the surgical procedure and the questionnaires of the study
* Written informed consent
Exclusion Criteria:
* Anal sphincter dyssynergia
* Coexisting recto-anal intussusception on defecography or external rectal prolapse (grades III, IV and V Oxford Prolapse Grading System)
* Coexisting enterocele compressing/obstructing the rectum on defecography (type B enterocele: the enterocele descends beyond the PCL to the perineum through the rectovaginal space to compress the rectal ampulla at the end of the evacuation process; type C enterocele (obstructive): the enterocele descends beyond the PCL to the perineum through the rectovaginal space to compress the rectal ampulla at the beginning of the evacuation process)
* Slow transit constipation associated to obstructed defecation
* Severe psychiatric disorder
* Refusal to provide written informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03944720
Study Brief:
Protocol Section:
NCT03944720