NCT04197869

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

Completed Phase 4 Results posted Last updated 27 December 2024

What this trial tests

Phase 4 trial testing Polyethylene Glycol Powder in Constipation in 71 participants. Completed in 21 June 2023.

Timeline

9 December 2019

Primary endpoint
21 June 2023

21 June 2023

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	9 December 2019
Primary completion	21 June 2023
Estimated completion	21 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Polyethylene Glycol Powder — full drug profile →

Conditions studied

• Constipation — all drugs for Constipation →
• Post-Op Complication — all drugs for Post-Op Complication →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 89, female only, with Constipation or Post-Op Complication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

First Bowel Movement Primary · 7 days post-operatively

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

Group	Value	95% CI
Experimental	1.96	± 1
Control	2.32	± 0.99

Post Operative Pain With First Bowel Movement as Measured by the VAS Scale. Secondary · 7 days post-operatively

Patients will record their pain levels with 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.

Group	Value	95% CI
Experimental	1	0 – 2
Control	4	2 – 5

Post Operative Pain at Day 1 as Measured by the VAS Scale Secondary · 1 day post-operatively

Patients will record their pain level 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.

Group	Value	95% CI
Experimental	4	3 – 6
Control	2	0 – 4

Median Postoperative Pain Secondary · Averaged over 7 days post-operatively

Patients will record their pain level daily for 7 days 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. The average value over 7 days for each patient will be calculated. We will then report the median postoperative pain score averaged across 7 days for each group.

Group	Value	95% CI
Experimental	1.3	0 – 2.9
Control	3.2	2.3 – 3.6

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, an average of 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental

Serious: 0/24 (0%)

Deaths: 0/24

Control

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (1 terms — click to expand)

Reaction	System	Experimental	Control
loose stool	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04197869 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.