Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01618292

Enrollment

393

Registered

2012-06-13

Start date

2007-01-31

Completion date

2012-08-31

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

PROCEDURERobotic sacral colpopexy

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* All patients who underwent robotic assisted laparoscopic sacral colpopexy

Exclusion criteria

* Any other procedure for the treatment of pelvic organ prolapse

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026