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Completed

NCT Number: NCT04380090

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Miralax, PEG 3350

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

Other names: Colace

Primary outcomes

  1. Bowel Movement (BM) Within 3 Days of Surgery

    Time frame: 3 days postoperative

    Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement

Secondary outcomes

  1. Straining With BM

    Time frame: 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

  2. Pain With BM

    Time frame: 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

Other outcomes

  1. Laxative Use Within 3 Days of Surgery

    Time frame: 3 days postoperative

    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.

  2. Opioid Use Within 3 Days of Surgery

    Time frame: 3 days postoperative

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 8, 2020
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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