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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01805310
Other study ID # PRO12020453
Secondary ID
Status Completed
Phase Phase 4
First received March 1, 2013
Last updated January 5, 2018
Start date February 2013
Est. completion date August 2017

Study information

Verified date January 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations.

Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations.

This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female

- Age = 18 years

- Planned laparoscopic or robotic-assisted sacral colpopexy

Exclusion Criteria:

- History of ulcerative colitis or Crohn's disease

- Prior large or small bowel resection

- Known diagnosis of gastroparesis

- Prior pelvic radiation

- History of abdominal or pelvic malignancy

- Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair

- Pregnancy

- Known allergic reactions to components of the study products

- Known renal insufficiency

- Non-English speaking as the primary study questionnaires are all currently in English only

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bowel preparation
Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.
No bowel preparation
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Halina M Zyczynski, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PAC-SYM Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool. 1 year
Secondary Surgeon perception of bowel preparation Immediately after completing the surgical case, surgeons will complete a 13-item surgeon questionnaire assessing degree of surgical difficulty and how it relates to the bowel. Operative time and consultations will also be recorded as objective measures of surgical difficulty. 1 year
Secondary Return of normal bowel function A seven-day bowel diary will be obtained at baseline and in the first week after surgery. This log will include daily assessment of bowel frequency, type of bowel movement using the validated Bristol stool scale, degree of straining, and used of narcotics or laxatives. 1 year
Secondary Perioperative complications Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions. 1 year
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