Post-Operative Constipation Following Total Knee Arthroplasty

NCT ID: NCT04380090

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2020-07-15

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.

Conditions

Constipation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Drug: Docusate Sodium

Docusate sodium one pill to be taken twice a day by mouth for 28 days

Group Type: ACTIVE_COMPARATOR

Docusate Sodium

Intervention Type: 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

Drug: Propylene Glycol

One standard dose (17 grams) of propylene glycol by mouth on postoperative day one

Group Type: EXPERIMENTAL

Propylene Glycol

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Miralax; PEG 3350; Colace

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Gonzalez

Interim Director of Perioperative Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Gonzalez, RN, MSN

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37708528 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-080

Identifier Type: -

Identifier Source: org_study_id