Trial Outcomes & Findings for Effect of Preoperative Fiber on Postoperative Bowel Function (NCT NCT04882995)
NCT ID: NCT04882995
Last Updated: 2022-06-28
Results Overview
Date and time of first bowel movement captured via postoperative bowel diary
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Within 7 days
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Intervention - Received Fiber
Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
|
Control - Did Not Receive Fiber
Participants did not take any preoperative fiber.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Intervention - Received Fiber
Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
|
Control - Did Not Receive Fiber
Participants did not take any preoperative fiber.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
4
|
4
|
|
Overall Study
Surgery postponed due to COVID
|
1
|
1
|
Baseline Characteristics
Effect of Preoperative Fiber on Postoperative Bowel Function
Baseline characteristics by cohort
| Measure |
Intervention - Received Fiber
n=35 Participants
Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
|
Control - Did Not Receive Fiber
n=36 Participants
Participants did not take any preoperative fiber.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
60 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
60.3 years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
PAC-SYM
|
0.5 units on a scale
n=93 Participants
|
0.3 units on a scale
n=4 Participants
|
0.3 units on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: Within 7 daysDate and time of first bowel movement captured via postoperative bowel diary
Outcome measures
| Measure |
Intervention - Received Fiber
n=35 Participants
Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
|
Control - Did Not Receive Fiber
n=36 Participants
Participants did not take any preoperative fiber.
|
|---|---|---|
|
Time to First Bowel Movement After Surgery
|
66.5 hours
Standard Deviation 22.7
|
68.3 hours
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Within 7 daysPain captured with visual analog scale with 0 being no pain and 10 being worst pain
Outcome measures
| Measure |
Intervention - Received Fiber
n=35 Participants
Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.
|
Control - Did Not Receive Fiber
n=36 Participants
Participants did not take any preoperative fiber.
|
|---|---|---|
|
Pain Associated With First Bowel Movement After Surgery
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 0.0 to 4.0
|
Adverse Events
Intervention - Received Fiber
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Did Not Receive Fiber
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