Trial Outcomes & Findings for Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy (NCT NCT04197869)
NCT ID: NCT04197869
Last Updated: 2024-12-27
Results Overview
Time to first post-operative bowel movement will be evaluated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
7 days post-operatively
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Experimental
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
The control group will not be given any intervention preoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
Baseline characteristics by cohort
| Measure |
Experimental
n=24 Participants
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
n=25 Participants
The control group will not be given any intervention preoperatively.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days post-operativelyTime to first post-operative bowel movement will be evaluated.
Outcome measures
| Measure |
Experimental
n=24 Participants
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
n=25 Participants
The control group will not be given any intervention preoperatively.
|
|---|---|---|
|
First Bowel Movement
|
1.96 days
Standard Deviation 1
|
2.32 days
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: 7 days post-operativelyPopulation: one experimental patient did not report this data point therefore there were 23, not 24, patients analyzed
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.
Outcome measures
| Measure |
Experimental
n=23 Participants
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
n=25 Participants
The control group will not be given any intervention preoperatively.
|
|---|---|---|
|
Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.
|
1 units on a scale
Interval 0.0 to 2.0
|
4 units on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 day post-operativelyPopulation: Some patients did not report this data point therefore there were fewer patients analyzed than were described in the Participant Flow
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.
Outcome measures
| Measure |
Experimental
n=18 Participants
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
n=21 Participants
The control group will not be given any intervention preoperatively.
|
|---|---|---|
|
Post Operative Pain at Day 1 as Measured by the VAS Scale
|
4 units on a scale
Interval 3.0 to 6.0
|
2 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Averaged over 7 days post-operativelyPopulation: One patient did not report this data point therefore there were fewer patients analyzed than were described in the Participant Flow
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.
Outcome measures
| Measure |
Experimental
n=23 Participants
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
n=25 Participants
The control group will not be given any intervention preoperatively.
|
|---|---|---|
|
Median Postoperative Pain
|
1.3 units on a scale
Interval 0.0 to 2.9
|
3.2 units on a scale
Interval 2.3 to 3.6
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental
n=24 participants at risk
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
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.
|
Control
n=25 participants at risk
The control group will not be given any intervention preoperatively.
|
|---|---|---|
|
Gastrointestinal disorders
loose stool
|
12.5%
3/24 • through study completion, an average of 1 month
|
0.00%
0/25 • through study completion, an average of 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place