Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Halina M Zyczynski, MD

Status and phase: Completed; Phase 4

Conditions: Pelvic Organ Prolapse; Prolapse

Treatments: Other: Bowel preparation; Other: No bowel preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT01805310

PRO12020453

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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95 participants in 2 patient groups

Bowel Preparation

Other group

Description:

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.

Treatment:

Other: Bowel preparation

No bowel preparation

Other group

Description:

Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Treatment:

Other: No bowel preparation