Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Completed

• Conditions: Constipation; Pelvic Organ Prolapse; Bowel Dysfunction; Irritable Bowel Syndrome
• Interventions: Procedure: Robotic sacral colpopexy

• Registration Number: NCT01618292
• Lead Sponsor: Atlantic Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 393

Inclusion Criteria

• All patients who underwent robotic assisted laparoscopic sacral colpopexy

Exclusion Criteria

• Any other procedure for the treatment of pelvic organ prolapse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic-assisted sacrocolpopexy patients	Robotic sacral colpopexy	Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States