- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618292
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
January 27, 2014 updated by: Jennifer Pagnillo, Atlantic Health System
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
393
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Morristown, New Jersey, United States, 07960
- Atlantic Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women suffering from pelvic organ prolapse who underwent a robotic assisted laparoscopic sacral colpopexy between January 2007 and August 2011.
Description
Inclusion Criteria:
- All patients who underwent robotic assisted laparoscopic sacral colpopexy
Exclusion Criteria:
- Any other procedure for the treatment of pelvic organ prolapse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Robotic-assisted sacrocolpopexy patients
Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011.
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Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in bowel function
Time Frame: preoperatively, 6 months, and one year post-surgery
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-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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective anatomic outcomes
Time Frame: preoperatively, 6 months, and one year after surgery
|
The pelvic organ prolapse quantification system (POP-Q)- an objective, validated, standardized method of quantifying the degree of pelvic organ prolapse present was used at all visits.
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preoperatively, 6 months, and one year after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
June 11, 2012
First Submitted That Met QC Criteria
June 12, 2012
First Posted (ESTIMATE)
June 13, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R11-08-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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