Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

• Sponsor: Atlantic Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT01618292
• Collaborator: (none)
• Enrollment: 393
• Location: 1
• Duration (Months): 67
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Constipation; Bowel Dysfunction; Irritable Bowel Syndrome	Procedure: Robotic sacral colpopexy

Study Design

• Study Type: Observational
• Actual Enrollment: 393 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: robotic-assisted laparoscopic sacral colpopexy

Outcome Measures

Primary Outcome Measures

1. Changes in bowel function [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

Secondary Outcome Measures

1. Objective anatomic outcomes [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Atlantic Health System	Morristown	New Jersey	United States	07960

Sponsors and Collaborators

• Atlantic Health System

Investigators

• Principal Investigator: Patrick Culligan, MD, Atlantic Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Pagnillo, Patrick Culligan, MD, Atlantic Health System
• ClinicalTrials.gov Identifier: NCT01618292
• Other Study ID Numbers: R11-08-011
• First Posted: Jun 13, 2012
• Last Update Posted: Jan 28, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Jennifer Pagnillo, Patrick Culligan, MD, 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: Irritable Bowel Syndrome; Intestinal Diseases; Constipation; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Jan 28, 2014