Pelvic Organ ProlapseNCT01618292
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
An observational study of Pelvic Organ Prolapse and Constipation, run by Atlantic Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Constipation, Bowel Dysfunction
- What is being tested?
- Robotic sacral colpopexy
- Type of treatment
- Surgery or procedure
- How many people
- 393 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women suffering from pelvic organ prolapse who underwent a robotic assisted laparoscopic sacral colpopexy between January 2007 and August 2011.
Who may be able to join
- All patients who underwent robotic assisted laparoscopic sacral colpopexy
Who cannot join
- Any other procedure for the treatment of pelvic organ prolapse
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
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.
- Being tested
- Robotic sacral colpopexy
- Keywords
- 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
- Medical subject headings
- Pelvic Organ Prolapse, Constipation, Intestinal Diseases, Irritable Bowel Syndrome, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic sacral colpopexyProcedure or surgery
Also called robotic-assisted laparoscopic sacral colpopexy
Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted sacrocolpopexy patients | Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011. Receives: Procedure: Robotic sacral colpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: preoperatively, 6 months, and one year post-surgery
Secondary outcomes (1)
Objective anatomic outcomes
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.
Measured: preoperatively, 6 months, and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJan 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Pagnillo, Atlantic Health System
- Investigators
- Patrick Culligan, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618292
- Sponsor's protocol ID
- R11-08-011
- Status last verified
- Jan 2014
- First submitted
- 11 Jun 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT01618292
- Acronym / sponsor ID
- R11-08-011
- Keywords
- pelvic organ prolapse, constipation, bowel dysfunction, irritable bowel syndrome (IBS), CRADI-8, CRAIQ-7, splinting with defecation, excessive straining
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted sacrocolpopexy patients | – | Procedure: Robotic sacral colpopexyPatients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women suffering from pelvic organ prolapse who underwent a robotic assisted laparoscopic sacral colpopexy between January 2007 and August 2011.
Key inclusion criteria (1 listed)
- All patients who underwent robotic assisted laparoscopic sacral colpopexy
Key exclusion criteria (1 listed)
- Any other procedure for the treatment of pelvic organ prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic sacral colpopexyAlso: robotic-assisted laparoscopic sacral colpopexyPatients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse | Procedure or surgery | Robotic-assisted sacrocolpopexy patients |
Primary outcome
Changes in bowel function
Time frame: preoperatively, 6 months, and one year post-surgery
-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
1 secondary outcome
Objective anatomic outcomes
Time frame: preoperatively, 6 months, and one year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Culligan, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Constipation, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bowel function (time frame: preoperatively, 6 months, and one year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014; AzTrials last refreshed its copy on 7 Nov 2026.