Post-Operative Constipation Following Total Knee Arthroplasty

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: Docusate Sodium; Drug: Propylene Glycol

• Registration Number: NCT04380090
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-21
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Results First Submitted: 2021-09-27
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-18
• Last Update Submitted: 2022-01-18
• Results First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Docusate Sodium	Docusate Sodium	Docusate sodium one pill to be taken twice a day by mouth for 28 days
Drug: Propylene Glycol	Propylene Glycol	One standard dose (17 grams) of propylene glycol by mouth on postoperative day one

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Cleveland Clinic Lutheran Hospital; 🇺🇸 Cleveland, Ohio, United States