Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Study Overview
=================
Brief 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.

Official Title
-----------------
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Conditions
-----------------
Prolapse, Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Other: Bowel preparation
* Other: No bowel preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bowel Preparation<br>Women randomized to the bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one. They will also be placed on a clear liquid diet on preoperative day number one. | Other: Bowel preparation<br>* 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.<br>* Other names: Magnesium citrate;|
| Other: No bowel preparation<br>Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one. | Other: No bowel preparation<br>* Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic organ prolapse, Prolapse, Cathartics, Mechanical bowel preparation