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

NCT04197869 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 19-0802
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Post-Op Complication

Outcome Measures

Primary Outcomes (1)

• First Bowel Movement

  Time to first post-operative bowel movement will be evaluated.

  7 days post-operatively

Secondary Outcomes (3)

• Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.

  7 days post-operatively

• Post Operative Pain at Day 1 as Measured by the VAS Scale

  1 day post-operatively

• Median Postoperative Pain

  Averaged over 7 days post-operatively

Study Arms (2)

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

Control

NO INTERVENTION

The control group will not be given any intervention preoperatively.

Interventions

Polyethylene Glycol Powder DRUG

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health

Bay Shore, New York, 11706, United States

Location

Related Publications (1)

• Holubyeva A, Goodwin AI, O'Shaughnessy D, Pillalamarri N, Demertzis K, Rahbani AC, Stefanov DG, Finamore PS. Does a Preoperative Bowel Regimen Change Time to Bowel Movement? A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):251-255. doi: 10.1097/SPV.0000000000001462. Epub 2024 Feb 26.

  PMID: 38484239 DERIVED

MeSH Terms

Conditions

Constipation; Postoperative Complications

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Dr. Alexandra Goodwin
• Organization: UCLA Health

zangoodwin@gmail.com

917-969-1654

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: December 9, 2019
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Locations

US (1)