Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
This study is currently recruiting participants.
Verified June 2012 by Atlantic Health System
Sponsor:
Atlantic Health System
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01618292
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse Constipation Bowel Dysfunction Irritable Bowel Syndrome |
Procedure: Robotic sacral colpopexy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy |
Resource links provided by NLM:
Further study details as provided by Atlantic Health System:
Primary Outcome Measures:
- Changes in bowel function [ Time Frame: preoperatively, 6 months, and one year post-surgery ] [ Designated as safety issue: No ]-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
Secondary Outcome Measures:
- Objective anatomic outcomes [ Time Frame: preoperatively, 6 months, and one year after surgery ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 423 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Robotic-assisted sacrocolpopexy patients
Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011.
|
Procedure: Robotic sacral colpopexy
Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse
Other Name: robotic-assisted laparoscopic sacral colpopexy
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria:
- All patients who underwent robotic assisted laparoscopic sacral colpopexy
Exclusion Criteria:
- Any other procedure for the treatment of pelvic organ prolapse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618292
Contacts
| Contact: Christa Lewis, MD | 973-971-7430 | christa.lewis@atlantichealth.org |
| Contact: Jodie Komar, BSN | 973-971-7426 | jodie.komar@atlantichealth.org |
Locations
| United States, New Jersey | |
| Atlantic Health System | Recruiting |
| Morristown, New Jersey, United States, 07960 | |
| Contact: Christa Lewis, MD 973-971-7430 christa.lewis@atlantichealth.org | |
| Contact: Jodie Komar, BSN 973-971-7426 jodie.komar@atlantichealth.org | |
| Principal Investigator: Patrick Culligan, MD | |
Sponsors and Collaborators
Atlantic Health System
Investigators
| Principal Investigator: | Patrick Culligan, MD | Atlantic Health System |
More Information
No publications provided
| Responsible Party: | Jodie Komar, Patrick Culligan, MD, Atlantic Health System |
| ClinicalTrials.gov Identifier: | NCT01618292 History of Changes |
| Other Study ID Numbers: | R11-08-011 |
| Study First Received: | June 11, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Atlantic Health System:
|
pelvic organ prolapse constipation bowel dysfunction irritable bowel syndrome (IBS) CRADI-8 CRAIQ-7 |
splinting with defecation excessive straining bowel movements fecal incontinence bowel symptoms |
Additional relevant MeSH terms:
|
Constipation Intestinal Diseases Gastrointestinal Diseases Irritable Bowel Syndrome Prolapse Pelvic Organ Prolapse |
Signs and Symptoms, Digestive Signs and Symptoms Digestive System Diseases Colonic Diseases, Functional Colonic Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013