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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT06804993
Eligibility Criteria:
Inclusion Criteria: all required
* female patients
* symptomatic rectocele
* failed conservative treatments for at least 3 months
* anterior rectocele larger than 3 cm in size in defecogram.
* retention of the contrast in the rectocele on defecography
* obstructed defecation manifestations: excessive straining, a sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia
Exclusion Criteria:
* significant urinary manifestations due to anterior vaginal wall prolapse
* recurrent rectocele
* previous anal surgery
* slow-transit constipation
* faecal incontinence (FI)
* abnormal thyroid functions
* patients under systemic steroid treatment
* patients with connective tissue disease
* ASA classification \>3
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06804993
Study Brief:
Protocol Section:
NCT06804993