Post-Operative Constipation Following Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: Docusate Sodium; Drug: Propylene Glycol

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44113
      • Cleveland Clinic Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug: Docusate Sodium; Docusate sodium one pill to be taken twice a day by mouth for 28 days	Drug: 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; Other Names: Colace
Experimental: Drug: Propylene Glycol; One standard dose (17 grams) of propylene glycol by mouth on postoperative day one	Drug: 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; Other Names: Miralax; PEG 3350

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kathleen Gonzalez, RN, MSN, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: total knee arthroplasty; postoperative; constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Antidiarrheals; Bismuth subsalicylate
• Other Study ID Numbers: 20-080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No