Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Pagnillo, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01618292
First received: June 11, 2012
Last updated: January 27, 2014
Last verified: January 2014
  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.


Enrollment: 393
Study Start Date: January 2007
Study Completion Date: August 2012
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

Locations
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Patrick Culligan, MD Atlantic Health System
  More Information

No publications provided

Responsible Party: Jennifer Pagnillo, 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: January 27, 2014
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 April 17, 2014