Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy

Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial

The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.

Study Overview

• Status: Completed
• Conditions: Constipation; Post-Op Complication
• Intervention / Treatment: Drug: Polyethylene Glycol Powder

Detailed Description

In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexandra Goodwin, MD; Phone Number: 6319683322; Email: agoodwin2@northwell.edu

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • South Shore University Hospital Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures

Exclusion Criteria:

• Age under 18 or over 90
• Planned laparotomy
• Planned posterior colporrhaphy
• Regular pre-operative use of stool softeners/laxatives
• Presence of colostomy
• Inability to give informed consent
• Inability to take medication by mouth
• Chronic kidney disease (Cr > 1.2)
• Esophageal strictures
• Persistent nausea and vomiting
• Bowel obstruction
• Inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.	Drug: Polyethylene Glycol Powder; Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels.
No Intervention: Control; The control group will not be given any intervention preoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First bowel movement	Time to first post-operative bowel movement will be evaluated.	7 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain as measured by the VAS scale.	Patients will record their daily pain levels using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.	7 days post-operatively
Post operative pain with first bowel movement as measured by the VAS scale	Patients will record their pain level with their first post-operative bowel movement using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.	7 days post-operatively
Stool consistency of first bowel movement as measure by the Bristol Stool Scale	Patients will record the stool consistency with their first bowel movement post-operatively using the Bristol Stool Scale. The scale is composed of stool types 1-7 with 1 being hard and lumpy stool and 7 being completely liquid.	7 days post-operatively

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Constipation; Postoperative Complications
• Other Study ID Numbers: 19-0802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No