An interventional study of Insertion of pelvicol graft in Rectocele, sponsored by Urogynecology Associates, Indiana. Status unknown at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-02.
Sponsored by Urogynecology Associates, Indiana · Not applicable, Interventional, and Treatment
Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →This is the only study on the registry with Urogynecology Associates, Indiana as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Insertion of pelvicol graft
No graft material
Pelvicol graft
Anatomic success of rectocele repair
Time frame: 6 months
change in patient symptomatology post-operatively
Time frame: 6 months
The record gives a start of Sep 2009, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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