Bowel Function After Minimally Invasive Urogynecologic Surgery

University of Rochester72 enrolled

Overview

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.

See above

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Functional Disorder of Intestine

Interventions

DocusateDRUG

Docusate 100mg BID

Bowel medicationsDRUG

Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

Time to First Post-op Bowel Movement

The time to first post-operative bowel movement was measured in hours after surgery.

Time frame: Within 1 week of surgery

Secondary Outcomes

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.

Time frame: Within 1 week of surgery

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

Time frame: Within 1 week of surgery

Data from ClinicalTrials.gov

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