Clinical trial NCT04380090: Post-Operative Constipation Following Total Knee Arthroplasty
Official title: Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: constipation
postoperative
total knee arthroplasty
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Bowel Movement (BM) Within 3 Days of Surgery
timeFrame: 3 days postoperative
Secondary outcomes:
measure: Straining With BM
timeFrame: 3 days postoperative
measure: Pain With BM
timeFrame: 3 days postoperative
Other outcomes:
measure: Laxative Use Within 3 Days of Surgery
timeFrame: 3 days postoperative
measure: Opioid Use Within 3 Days of Surgery
timeFrame: 3 days postoperative
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Lutheran Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kathleen Gonzalez, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References: