Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

NCT01618292 | Completed DMC

• 1 other identifier: R11-08-011
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Constipation; Bowel Dysfunction; Irritable Bowel Syndrome

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

Outcome Measures

Primary Outcomes (1)

• 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

  preoperatively, 6 months, and one year post-surgery

Secondary Outcomes (1)

• Objective anatomic outcomes

  preoperatively, 6 months, and one year after surgery

Study Arms (1)

Robotic-assisted sacrocolpopexy patients

Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011.

Procedure: Robotic sacral colpopexy

Interventions

Robotic sacral colpopexy PROCEDURE

Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse

Also known as: robotic-assisted laparoscopic sacral colpopexy

Robotic-assisted sacrocolpopexy patients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients who underwent robotic assisted laparoscopic sacral colpopexy

You may not qualify if:

• Any other procedure for the treatment of pelvic organ prolapse

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Constipation; Intestinal Diseases; Irritable Bowel Syndrome; Fecal Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Rectal Diseases

Study Officials

• Patrick Culligan, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patrick Culligan, MD

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: January 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

US (1)