Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

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.

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Key information

Conditions

Pelvic Organ Prolapse Bowel Dysfunction Colonic Diseases Colonic Diseases, Functional Constipation Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

Female

Study type

Observational

Primary location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who underwent robotic assisted laparoscopic sacral colpopexy

Exclusion criteria

Any other procedure for the treatment of pelvic organ prolapse

Treatment and study plan

Robotic sacral colpopexy

Procedure

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

Other names: robotic-assisted laparoscopic sacral colpopexy

Primary outcomes

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

Secondary outcomes

Objective anatomic outcomes

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Jun 13, 2012
Registry last updated: Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed