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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Docusate Sodium | Active Comparator | Docusate sodium one pill to be taken twice a day by mouth for 28 days |
|
| Drug: Propylene Glycol | Experimental | One standard dose (17 grams) of propylene glycol by mouth on postoperative day one |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propylene Glycol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 days postoperative |
| Pain With BM |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days postoperative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Gonzalez, RN, MSN | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Lutheran Hospital | Cleveland | Ohio | 44113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37708528 | Derived | Gonzalez K, Sanchez K, Mauch K, Burchill CN, Bena JF, Morrison SL, Distelhorst KS. Efficacy of One Dose of Laxative on Postoperative Constipation Following Total Knee Arthroplasty. Orthop Nurs. 2023 Sep-Oct 01;42(5):304-309. doi: 10.1097/NOR.0000000000000971. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Study participants who completed the follow-up phone call | Posted | Count of Participants | Participants | 3 days postoperative |
|
7 days postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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We did not consider, in this study, the amount of opioids used by patients postoperatively. An additional limitation was that only one dose of Miralax was used in the intervention group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Gonzalez | Cleveland Clinic Lutheran Hospital | 2162174226 | gonzalk2@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2020 | Sep 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019946 | Propylene Glycol |
| C000595212 | polyethylene glycol 3350 |
| D004143 | Dioctyl Sulfosuccinic Acid |
| ID | Term |
|---|---|
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Docusate Sodium | Drug | 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 |
|
|
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
| 3 days postoperative |
| 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. | 3 days postoperative |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Saphenous Nerve Block | Count of Participants | Participants |
|
| Type of anesthesia | Count of Participants | Participants |
|
| Length of Surgery (minutes) | Mean | Standard Deviation | Minutes |
|
| Quan-Charlson Comorbidity Index | The Quan Charlson Comorbidity Index (CCI) assesses comorbidity level using the number and severity of 12 pre-defined comorbid conditions. Each of the 12 items is scored between 1-6 (if present), and 0 if not present; total possible score = 28 and higher scores reflect higher comorbidity burden. The total weighted score was calculated for each subject. Median (IQR) was used in the analysis due to kurtosis. | Median | Inter-Quartile Range | total weighted score |
|
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 |
|
|
|
| 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 | Participants who completed the follow up phone call and reported having a BM within 3 days | Posted | Number | participants | 3 days postoperative |
|
|
|
|
| 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 | Participants who completed the follow up phone call and reported having a BM within 3 days | Posted | Count of Participants | Participants | 3 days postoperative |
|
|
|
|
| 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. | Study participants who completed the follow-up phone call | Posted | Count of Participants | Participants | 3 days postoperative |
|
|
|
|
| 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. | Study participants who completed the follow up phone call | Posted | Count of Participants | Participants | 3 days postoperative |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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. | 0 | 58 | 0 | 58 | 0 | 58 |
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| D013386 |
| Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| score = 2 |
|
| score 2 |
|