Constipation
Conditions
Keywords
constipation, postoperative, total knee arthroplasty
Brief summary
Postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. Causes include intraoperative medications, postoperative opioid analgesics, decreased mobility, and decreased oral intake. Constipation significantly impacts quality of life following surgery. Current standard of care for preventing postoperative constipation for patients having a single total knee arthroplasty at Cleveland Clinic is discharge on postoperative day one with either a prescription to be filled for docusate sodium (brand name Colace®) 100 mg to be taken two times a day by mouth for twenty eight days or the filled prescription, plus discharge instructions on ways to avoid and treat constipation. Research results show that docusate sodium is ineffective for preventing postoperative constipation in orthopedic surgery patients, and anecdotal reports confirm this finding. The proposed study uses a 2-group non-equivalent cohort design to evaluate the effect of one standard dose (17 grams) of an over-the-counter osmotic laxative (propylene glycol (PEG 3350), brand name Miralax) by mouth prior to discharge to the current standard of care. The primary outcome measure is whether patients report of a fully satisfying, normal for them, bowel movement within the first three postoperative days. Patient reported data will be collected by phone call four to seven days following surgery. Pertinent patient characteristics will be abstracted from the electronic medical record. The sample will consist of patients over twenty years old having a single total knee arthroplasty by Drs. Stearns, Molloy, or Murray who are admitted to unit 5D at Cleveland Clinic Lutheran Hospital postoperatively. Intent to treat analysis will be performed using logistic and linear regression models, adjusting for differences between groups on patient and surgical characteristics. Based on use of a two-sided Pearson chi-square test with 80% power and significance level of 0.05, 49 patients per group are required to detect a 25% decrease in constipation rate. To account for attrition we will over sample by 50% for a total of 74 per group or 148 total participants.
Interventions
DRUGPropylene 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
DRUGDocusate 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
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Admission to Cleveland Clinic Lutheran Hospital surgical unit 5D * Single total knee replacement surgery by orthopedic surgeons Stearns, Murray, or Molloy * Age greater than 20 * Discharge to home on postoperative day one
Exclusion criteria
* Known allergy to PEG 3350 * Unable to complete a follow up phone call in English * Known renal disease, irritable bowel syndrome, or inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Movement (BM) Within 3 Days of Surgery | 3 days postoperative | Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Straining With BM | 3 days postoperative | 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 |
| Pain With BM | 3 days postoperative | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Laxative Use Within 3 Days of Surgery | 3 days postoperative | 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. |
| Opioid Use Within 3 Days of Surgery | 3 days postoperative | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Drug: Docusate Sodium 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. | 60 |
| 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 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. | 58 |
| Total | 118 |
Baseline characteristics
| Characteristic | Drug: Docusate Sodium | Drug: Propylene Glycol | Total |
|---|---|---|---|
| Age, Continuous | 64.8 Years STANDARD_DEVIATION 8.2 | 65.2 Years STANDARD_DEVIATION 9.5 | 65 Years STANDARD_DEVIATION 8.8 |
| Length of Surgery (minutes) | 100.8 Minutes STANDARD_DEVIATION 20.3 | 95.7 Minutes STANDARD_DEVIATION 17 | 98.3 Minutes STANDARD_DEVIATION 18.8 |
| Quan-Charlson Comorbidity Index | 0.00 total weighted score | 0.50 total weighted score | 0.00 total weighted score |
| Race/Ethnicity, Customized Race/Ethnicity Asian American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 49 Participants | 44 Participants | 93 Participants |
| Saphenous Nerve Block No | 1 Participants | 0 Participants | 1 Participants |
| Saphenous Nerve Block Unknown | 0 Participants | 1 Participants | 1 Participants |
| Saphenous Nerve Block Yes | 59 Participants | 57 Participants | 116 Participants |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 67 Participants |
| Sex: Female, Male Male | 30 Participants | 21 Participants | 51 Participants |
| Type of anesthesia General | 6 Participants | 9 Participants | 15 Participants |
| Type of anesthesia Spinal | 54 Participants | 49 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 |
| other Total, other adverse events | 0 / 60 | 0 / 58 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 |
Outcome results
Primary
Bowel Movement (BM) Within 3 Days of Surgery
Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement
Time frame: 3 days postoperative
Population: Study participants who completed the follow-up phone call
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: Docusate Sodium | Bowel Movement (BM) Within 3 Days of Surgery | 29 Participants |
| Drug: Propylene Glycol | Bowel Movement (BM) Within 3 Days of Surgery | 32 Participants |
p-value: 0.4195% CI: [0.65, 2.86]Regression, Logistic
Secondary
Pain With BM
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
Time frame: 3 days postoperative
Population: Participants who completed the follow up phone call and reported having a BM within 3 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug: Docusate Sodium | Pain With BM | score 0 | 19 Participants |
| Drug: Docusate Sodium | Pain With BM | score 1 | 8 Participants |
| Drug: Docusate Sodium | Pain With BM | score 2 | 2 Participants |
| Drug: Propylene Glycol | Pain With BM | score 0 | 19 Participants |
| Drug: Propylene Glycol | Pain With BM | score 1 | 11 Participants |
| Drug: Propylene Glycol | Pain With BM | score 2 | 2 Participants |
p-value: 0.6595% CI: [0.45, 3.63]ordinal regression model
Secondary
Straining With BM
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
Time frame: 3 days postoperative
Population: Participants who completed the follow up phone call and reported having a BM within 3 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug: Docusate Sodium | Straining With BM | score = 0 | 6 participants |
| Drug: Docusate Sodium | Straining With BM | score = 1 | 18 participants |
| Drug: Docusate Sodium | Straining With BM | score = 2 | 5 participants |
| Drug: Propylene Glycol | Straining With BM | score = 0 | 7 participants |
| Drug: Propylene Glycol | Straining With BM | score = 1 | 21 participants |
| Drug: Propylene Glycol | Straining With BM | score = 2 | 4 participants |
p-value: 0.6695% CI: [0.28, 2.24]ordinal regression model
Other Pre-specified
Laxative Use Within 3 Days of Surgery
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.
Time frame: 3 days postoperative
Population: Study participants who completed the follow-up phone call
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: Docusate Sodium | Laxative Use Within 3 Days of Surgery | 16 Participants |
| Drug: Propylene Glycol | Laxative Use Within 3 Days of Surgery | 19 Participants |
p-value: 0.47Chi-squared
Other Pre-specified
Opioid Use Within 3 Days of Surgery
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.
Time frame: 3 days postoperative
Population: Study participants who completed the follow up phone call
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: Docusate Sodium | Opioid Use Within 3 Days of Surgery | 58 Participants |
| Drug: Propylene Glycol | Opioid Use Within 3 Days of Surgery | 57 Participants |
p-value: 0.99Fisher Exact