NCT04197869

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Constipation
• Post-Op Complication

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-09
• Primary completion: 2023-06-21
• Completion: 2023-06-21
• First posted: 2019-12-13
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study