Trial Outcomes & Findings for Prunes for Gastrointestinal Function After Gynecologic Surgery (NCT NCT03523715)
NCT ID: NCT03523715
Last Updated: 2021-04-08
Results Overview
Time to first bowel movement after surgery
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
3 days
Results posted on
2021-04-08
Participant Flow
Participant milestones
| Measure |
Prunes
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
Prunes
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
14
|
|
Overall Study
Did not meet inclusion criteria
|
1
|
0
|
|
Overall Study
Internally inconsistent reporting
|
0
|
2
|
Baseline Characteristics
Prunes for Gastrointestinal Function After Gynecologic Surgery
Baseline characteristics by cohort
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
50 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Post menopause
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Baseline Bristol Stool Scale
|
4 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysTime to first bowel movement after surgery
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Time to First Bowel Movement
|
57.6 hours post surgery
Standard Deviation 19.3
|
53.8 hours post surgery
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 3 daysBristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Stool Consistency of the First Bowel Movement
|
3 Bristol Stool Scale
Interval 2.0 to 5.0
|
4 Bristol Stool Scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 3 daysLikert scale from 0 to 10 in which higher values indicate more pain
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Pain With Bowel Movement Measured
|
60 Likert scale 0-100
Interval 25.0 to 80.0
|
40 Likert scale 0-100
Interval 10.0 to 70.0
|
SECONDARY outcome
Timeframe: 3 dayLikert scale from 0 to 10 in which higher values indicate more satisfaction
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Satisfaction With Bowel Regimen
|
100 Likert scale 0-100
Interval 70.0 to 100.0
|
80 Likert scale 0-100
Interval 45.0 to 95.0
|
SECONDARY outcome
Timeframe: 3 daysLikert scale from 0 to 10 in which higher levels indicate more satisfaction
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Satisfaction With Surgery Overall
|
100 Likert scale 0-100
Interval 90.0 to 100.0
|
100 Likert scale 0-100
Interval 97.5 to 100.0
|
SECONDARY outcome
Timeframe: 3 daysThe number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Requirements for Laxatives
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 5 daysThe number of participants who had a bowel movement in the post operative study follow up
Outcome measures
| Measure |
Prunes
n=26 Participants
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes: 12 oz of prunes daily
Docusate Sodium: Oral docusate sodium twice daily
|
Control
n=24 Participants
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
|
|---|---|---|
|
Bowel Movement in the Study Period
|
26 Participants
|
17 Participants
|
Adverse Events
Prunes
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place