Bowel Function After Minimally Invasive Urogynecologic Surgery

Functional Disorder of Intestine Clinical Trial

Official title:

Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044212
• Other study ID #: 29359
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: September 21, 2015
• Start date: November 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.

Procedures may include:

• robot-assisted laparoscopic sacrocolpopexy

• sacrospinous ligament suspension

• uterosacral ligament suspension/paravaginal defect repair

• colpocleisis

• cystocele repair

Additional procedures may include:

• hysterectomy

• adnexectomy

• culdoplasty

• minimally invasive sling procedure (TVT or TOT)

• periurethral collagen injections

• enterocele repair

Exclusion Criteria:

• Planning to undergo laparotomy.

• Undergoing rectocele or perineocele repair as part of surgery.

• Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.

• Presence of a colostomy.

• Chronic kidney disease

• Insulin-dependent diabetes mellitus

• Known cardiac disease

• Gastric ulcers

• Difficulty swallowing or esophageal stricture

• Persistent nausea and vomiting

• Signs and symptoms consistent with bowel obstruction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Functional Disorder of Intestine
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Drug:
• Docusate
Docusate 100mg BID
• Bowel medications
Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Post-op Bowel Movement	The time to first post-operative bowel movement was measured in hours after surgery.	Within 1 week of surgery	No
Secondary	Pain Level Associated With First Postoperative Bowel Movement	The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.	Within 1 week of surgery	No
Secondary	Consistency of First Postoperative Bowel Movement	The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.; The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid	Within 1 week of surgery	No