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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT03052816
Eligibility Criteria:
Inclusion Criteria:
* The inclusion criteria are the following:
* Consenting, English speaking women between ages 18 and 80 who will undergo same day vaginal female pelvic reconstructive surgery at MetroHealth Medical Center
* Ability to read VAS Scores
* Specific vaginal procedures include, but are not limited to:
* Periurethral bulking
* Perineoplasty
* Complete vaginectomy
* Le Forte colpocleisis
* Anterior repair
* Posterior repair
* Enterocele repair
* Anterior and posterior repair
* Anterior, posterior and enterocele repair
* Transvaginal mesh use
* Sacrospinous ligament fixation
* Uterosacral ligament suspension
* Vaginal paravaginal defect repair
* Midurethral Sling
* Sphincteroplasty
* Vaginal hysterectomy, for uterus 250 g or less
* Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s)
* Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele
* Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele
* Vaginal hysterectomy, for uterus greater than 250 g
* Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s)
* Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele
* Vaginal hysterectomy, for uterus greater than 250 g; with repair of enterocele
Exclusion Criteria:
* The exclusion criteria are the following:
* History of chronic pelvic pain
* Abdominal surgery
* Laparoscopic surgery
* History of psychiatric disease
* Currently taking analgesic medications
* Currently taking sedatives
* Liver disease
* Renal disease with CrCl \< 60cc/min.
* History of burns from application of ice.
* Women who did not consent for the study.
* Intraoperative concern for increased blood loss
* Unable to speak English
* Unable to understand VAS Scores
* Undergoing concomitant abdominal or laparoscopic procedures.
* Allergy to motrin, toradol, Percocet, Tylenol
* Active or history of peptic ulcer disease
* History of GI bleeding or perforation
* Hemorrhagic diathesis
* Severe uncontrolled heart failure
* Inflammatory bowel disease
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03052816
Study Brief:
Protocol Section:
NCT03052816