Bowel Function After Minimally Invasive Urogynecologic Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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See above

Conditions

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Functional Disorder of Intestine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Docusate

Docusate is the standard of care regimen

Group Type ACTIVE_COMPARATOR

Docusate

Intervention Type DRUG

Docusate 100mg BID

Bowel medications

Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Group Type EXPERIMENTAL

Bowel medications

Intervention Type DRUG

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

Interventions

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Docusate

Docusate 100mg BID

Intervention Type DRUG

Bowel medications

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

Intervention Type DRUG

Other Intervention Names

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Colace Colace Psyllium Polyethylene glycol Dulcolax

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes