Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805310
• Other study ID #: PRO12020453
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2013
• Last updated: January 5, 2018
• Start date: February 2013
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Bowel preparation
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.
• No bowel preparation
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Halina M Zyczynski, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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