Trial Outcomes & Findings for Post-Operative Constipation Following Total Knee Arthroplasty (NCT NCT04380090)
NCT ID: NCT04380090
Last Updated: 2022-01-19
Results Overview
Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
3 days postoperative
Results posted on
2022-01-19
Participant Flow
The study was conducted at a regional hospital within a large health system in Northeast Ohio. Recruitment began on 2/21/2020 and concluded on 7/9/2020.
Participant milestones
| Measure |
Drug: Docusate Sodium
Docusate sodium one pill to be taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
|
Drug: Propylene Glycol
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
78
|
|
Overall Study
COMPLETED
|
60
|
58
|
|
Overall Study
NOT COMPLETED
|
16
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Operative Constipation Following Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Drug: Docusate Sodium
n=60 Participants
Docusate sodium one pill to was taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm received the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days.
|
Drug: Propylene Glycol
n=58 Participants
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm received one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
65 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Saphenous Nerve Block
Yes
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Saphenous Nerve Block
No
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Saphenous Nerve Block
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Type of anesthesia
General
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Type of anesthesia
Spinal
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Length of Surgery (minutes)
|
100.8 Minutes
STANDARD_DEVIATION 20.3 • n=5 Participants
|
95.7 Minutes
STANDARD_DEVIATION 17.0 • n=7 Participants
|
98.3 Minutes
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Quan-Charlson Comorbidity Index
|
0.00 total weighted score
n=5 Participants
|
0.50 total weighted score
n=7 Participants
|
0.00 total weighted score
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 days postoperativePopulation: Study participants who completed the follow-up phone call
Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement
Outcome measures
| Measure |
Drug: Docusate Sodium
n=60 Participants
Docusate sodium one pill to be taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
|
Drug: Propylene Glycol
n=58 Participants
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
|
|---|---|---|
|
Bowel Movement (BM) Within 3 Days of Surgery
|
29 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 3 days postoperativePopulation: Participants who completed the follow up phone call and reported having a BM within 3 days
For patients who had a BM within 3 days: rated 0 no straining to 10 worst straining imaginable; 3 categories developed: 0 = score of 0; 1 = score of 1-5 and 2 = score of 6-10
Outcome measures
| Measure |
Drug: Docusate Sodium
n=29 Participants
Docusate sodium one pill to be taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
|
Drug: Propylene Glycol
n=32 Participants
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
|
|---|---|---|
|
Straining With BM
score = 0
|
6 participants
|
7 participants
|
|
Straining With BM
score = 1
|
18 participants
|
21 participants
|
|
Straining With BM
score = 2
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 3 days postoperativePopulation: Participants who completed the follow up phone call and reported having a BM within 3 days
For patients who had a BM within 3 days: rated 0 no pain to 10 worst pain imaginable; 3 categories developed: 0 = score of 0; 1 = score of 1-5 and 2 = score of 6-10
Outcome measures
| Measure |
Drug: Docusate Sodium
n=29 Participants
Docusate sodium one pill to be taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
|
Drug: Propylene Glycol
n=32 Participants
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
|
|---|---|---|
|
Pain With BM
score 1
|
8 Participants
|
11 Participants
|
|
Pain With BM
score 2
|
2 Participants
|
2 Participants
|
|
Pain With BM
score 0
|
19 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 days postoperativePopulation: Study participants who completed the follow-up phone call
Participant response to question: Did you take any laxatives to help you have a bowel movement in those first three days after your surgery?(yes/no) Rate of laxative use in the postoperative period was calculated for sensitivity analyses and possible adjustment of statistical models based on any group differences.
Outcome measures
| Measure |
Drug: Docusate Sodium
n=60 Participants
Docusate sodium one pill to be taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
|
Drug: Propylene Glycol
n=58 Participants
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
|
|---|---|---|
|
Laxative Use Within 3 Days of Surgery
|
16 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 days postoperativePopulation: Study participants who completed the follow up phone call
Participant response to question: In the first three days following your surgery, did you take any of the opioid pain medicine prescribed by your surgeon?(yes/no) Rate of opioid use in the postoperative period was calculated for sensitivity analyses and possible adjustment of statistical models based on any group differences.
Outcome measures
| Measure |
Drug: Docusate Sodium
n=60 Participants
Docusate sodium one pill to be taken twice a day by mouth for 28 days
Docusate Sodium: Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
|
Drug: Propylene Glycol
n=58 Participants
One standard dose (17 grams) of propylene glycol by mouth on postoperative day one
Propylene Glycol: Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
|
|---|---|---|
|
Opioid Use Within 3 Days of Surgery
|
58 Participants
|
57 Participants
|
Adverse Events
Drug: Docusate Sodium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Drug: Propylene Glycol
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