Trial Outcomes & Findings for Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery (NCT NCT03260426)
NCT ID: NCT03260426
Last Updated: 2020-01-31
Results Overview
Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
POD 2
Results posted on
2020-01-31
Participant Flow
Participant milestones
| Measure |
Clear Liquid Diet
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
Baseline characteristics by cohort
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 50 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 50 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 100 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Body Mass Index
|
23.6 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
22.7 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
23.1 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Prior abdominal surgery
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Site of surgery
Small bowel
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Site of surgery
Right colon
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Site of surgery
Subtotal/left
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Site of surgery
pelvis
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Diagnosis
IBD
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Diagnosis
Cancer
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Diagnosis
Other
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ostomy Use
Ileostomy
|
24 Participants
n=5 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
22 Participants
n=7 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
46 Participants
n=5 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
|
Ostomy Use
Colostomy
|
2 Participants
n=5 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
1 Participants
n=7 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
3 Participants
n=5 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
|
Ostomy Use
No ostomy
|
24 Participants
n=5 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
27 Participants
n=7 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
51 Participants
n=5 Participants • Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy.
|
|
Anastomosis
Anastomosis formed
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Anastomosis
No Anastomosis
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: POD 2Population: All participants undergoing surgery
Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Number of Participants Who Experienced Emesis on Post Operative Day 2
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: POD 0Population: All participants undergoing surgery
Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).
|
46 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All participants undergoing surgery
If antiemetics were used in
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Antiemetic Usage
|
37 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 30 daysLength of postoperative stay
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Hospital Stay
|
3 days
Standard Error 3.5
|
2.5 days
Standard Error 4.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All participants undergoing surgery
Development of post-operative ileus
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Post-operative Ileus
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: POD 1 and POD 2 and DischargePopulation: All participants undergoing surgery
Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Pain Score
POD 1
|
4 score on a scale
Interval 0.0 to 10.0
|
4 score on a scale
Interval 0.0 to 10.0
|
|
Pain Score
POD 2
|
3 score on a scale
Interval 0.0 to 10.0
|
4 score on a scale
Interval 0.0 to 10.0
|
|
Pain Score
Discharge
|
2 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: POD 1 and POD 2 and DischargePopulation: All participants undergoing surgery.
Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Nausea Score
Discharge
|
1 score on a scale
Interval 0.0 to 10.0
|
1 score on a scale
Interval 0.0 to 10.0
|
|
Nausea Score
POD 1
|
1 score on a scale
Interval 0.0 to 10.0
|
1 score on a scale
Interval 0.0 to 10.0
|
|
Nausea Score
POD 2
|
1 score on a scale
Interval 0.0 to 10.0
|
1 score on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: POD 1 and POD 2 and DischargePopulation: All participants undergoing surgery.
Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.
Outcome measures
| Measure |
Clear Liquid Diet
n=50 Participants
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 Participants
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Bloating Score
POD 1
|
3 score on a scale
Interval 0.0 to 10.0
|
2 score on a scale
Interval 0.0 to 10.0
|
|
Bloating Score
POD 2
|
2 score on a scale
Interval 0.0 to 10.0
|
2 score on a scale
Interval 0.0 to 10.0
|
|
Bloating Score
POD 3
|
2 score on a scale
Interval 0.0 to 10.0
|
2 score on a scale
Interval 0.0 to 10.0
|
Adverse Events
Clear Liquid Diet
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Regular Solid Diet
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clear Liquid Diet
n=50 participants at risk
Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
Regular Solid Diet
n=50 participants at risk
Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
|
|---|---|---|
|
Gastrointestinal disorders
Post-operative Ileus
|
22.0%
11/50 • 30 days
|
22.0%
11/50 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place