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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197869
• Other study ID #: 19-0802
• Status: Completed
• Phase: Phase 4
• Start date: December 9, 2019
• Est. completion date: June 21, 2023

Study information

• Verified date: September 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Post-Op Complication
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
United States	South Shore University Hospital Northwell Health	Bay Shore	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First bowel movement	Time to first post-operative bowel movement will be evaluated.	7 days post-operatively
Secondary	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
Secondary	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
Secondary	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