ConstipationPhase 2NCT04380090
Post-Operative Constipation Following Total Knee Arthroplasty
A Phase 2 study testing Propylene Glycol and Docusate Sodium in people with Constipation, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Propylene Glycol and Docusate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 15 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Lutheran Hospital
Cleveland, Ohio, 44113
About this study
Official title: Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty
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.
- Conditions
- Constipation
- Being tested
- Propylene Glycol, Docusate Sodium
- Keywords
- constipation, postoperative, total knee arthroplasty
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propylene GlycolDrug
Also called Miralax, PEG 3350
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
Docusate SodiumDrug
Also called Colace
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
| Study group | Role | What they receive |
|---|---|---|
| Drug: Docusate Sodium | Active comparator | Docusate sodium one pill to be taken twice a day by mouth for 28 days Receives: Drug: Docusate Sodium |
| Drug: Propylene Glycol | Experimental | One standard dose (17 grams) of propylene glycol by mouth on postoperative day one Receives: Drug: Propylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days postoperative
Secondary outcomes (2)
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
Measured: 3 days postoperative
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
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start21 Feb 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Gonzalez, The Cleveland Clinic
- Investigators
- Kathleen Gonzalez, RN, MSN, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380090
- Sponsor's protocol ID
- 20-080
- Status last verified
- Jan 2022
- First submitted
- 5 May 2020
- Last updated
- 19 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37708528
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04380090
- Acronym / sponsor ID
- 20-080
- Conditions
- Constipation
- Keywords
- constipation, postoperative, total knee arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Posted 19 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Docusate Sodium | Active comparator | Drug: Docusate SodiumDocusate sodium one pill to be taken twice a day by mouth for 28 days |
| Drug: Propylene Glycol | Experimental | Drug: Propylene GlycolOne standard dose (17 grams) of propylene glycol by mouth on postoperative day one |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propylene GlycolAlso: Miralax, PEG 3350Patients 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 | Drug | Drug: Propylene Glycol |
| Docusate SodiumAlso: ColacePatients 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 | Drug: Docusate Sodium |
Primary outcome
Bowel Movement (BM) Within 3 Days of Surgery
Time frame: 3 days postoperative
Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement
2 secondary outcomes
Straining With BM
Time frame: 3 days postoperative
Pain With BM
Time frame: 3 days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37708528Gonzalez 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Gonzalez, RN, MSN principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propylene Glycol and Docusate Sodium in people with Constipation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Movement (BM) Within 3 Days of Surgery (time frame: 3 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.