NCT01618292|CompletedDMC
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Sponsor study identifier
observational
393
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
August 2012
Actual (reported)Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 11, 2012
Actual (reported)June 13, 2012
Actual (reported)August 2012
Actual (reported)August 2012
Actual (reported)Changes in bowel function
-Patients completed a validated colo-rectal-anal distress inventory (CARDI-8) at all 3 intervals. Specific complaints of splinting with defecation, excessive straining/pain with bowel movements, incomplete bowel emptying/obstructive symptoms and fecal incontinence were addressed. In addition, patients completed a validated colorectal-anal impact questionnaire (CRAIQ-7) at all 3 intervals. The CRAIQ-7 addresses bowel symptoms and the extend of quality of life impingement
preoperatively, 6 months, and one year post-surgery
Objective anatomic outcomes
preoperatively, 6 months, and one year after surgery
Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011.
Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women suffering from pelvic organ prolapse who underwent a robotic assisted laparoscopic sacral colpopexy between January 2007 and August 2011.
Atlantic Health System
Morristown, New Jersey, 07960, United States
Patrick Culligan, MD
Atlantic Health System
393 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2012
First Posted
June 13, 2012
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year
Contact the study team to confirm eligibility.
Primary Completion
August 2012
Actual (reported)Study Completion
August 2012
Actual (reported)Last Updated
January 28, 2014
Record last verified: 2014-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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