Post-Operative Constipation Following Total Knee Arthroplasty

NCT04380090 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-080
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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

Keywords

constipation; postoperative; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Straining With BM

  3 days postoperative

• Pain With BM

  3 days postoperative

Other Outcomes (2)

• Laxative Use Within 3 Days of Surgery

  3 days postoperative

• Opioid Use Within 3 Days of Surgery

  3 days postoperative

Study Arms (2)

Drug: Docusate Sodium

ACTIVE COMPARATOR

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

Drug: Docusate Sodium

Drug: Propylene Glycol

EXPERIMENTAL

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

Drug: Propylene Glycol

Interventions

Propylene Glycol 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

Also known as: Miralax, PEG 3350

Drug: Propylene Glycol

Docusate Sodium 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

Also known as: Colace

Drug: Docusate Sodium

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113, United States

Location

Related Publications (1)

• 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.

  PMID: 37708528 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Propylene Glycol; polyethylene glycol 3350; Dioctyl Sulfosuccinic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids

Limitations and Caveats

We did not consider, in this study, the amount of opioids used by patients postoperatively. An additional limitation was that only one dose of Miralax was used in the intervention group.

Results Point of Contact

• Title: Kathleen Gonzalez
• Organization: Cleveland Clinic Lutheran Hospital

gonzalk2@ccf.org

2162174226

Study Officials

• Kathleen Gonzalez, RN, MSN

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Director of Perioperative Nursing

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: February 21, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2022-01

Locations

US (1)