Constipation
Conditions
Interventions
Study group:In addition to the standard care in the control group, patients in the intervention group received oral lubiprostone capsules (24 µg once daily) starting from the second postoperative day
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients scheduled to undergo primary unilateral total knee arthroplasty (TKA) for severe knee osteoarthritis; (2) Aged 40-80 years; (3) American Society of Anesthesiologists (ASA) physical status classification I-III preoperatively.
Exclusion criteria
Exclusion criteria: (1) Patients with severe dysfunction of vital organs (e.g., heart, lung, liver, or kidney); (2) Abnormal liver or kidney function (ALT/AST > 1.5×ULN, BUN > 8.3 mmol/L, Scr > 115 µmol/L); (3) Poorly controlled diabetes (fasting glucose > 10.0 mmol/L, random glucose > 16.7 mmol/L, or HbA1c > 9.0%) with infection risk as judged by investigators; (4) Patients with cognitive impairment or psychiatric disorders; (5) Severe coagulation disorders; (6) Severe concurrent medical or surgical conditions or frailty making surgery intolerable; (7) Severe instability not amenable to ligament-retaining TKA; (8) Active systemic or local infections; (9) Metabolic bone disease, radiation-induced bone disease, or tumors around the knee; (10) Women planning pregnancy, currently pregnant, or breastfeeding during the study; (11) Participation in another clinical trial within the past 3 months; (12) Investigator-determined ineligibility for other reasons; (13) Knee flexion deformity >= 30° or varus/valgus deformity >= 30°; (14) Allergy to study medications; (15) Opioid addiction; (16) Language barriers or inability to complete postoperative assessments; (17) Contraindications to laxatives (e.g., bowel obstruction or organic intestinal diseases); (18) Preoperative constipation refractory to: >= 4 weeks of osmotic laxatives (e.g., PEG, lactulose) at full dose, PRN stimulant laxatives (e.g., bisacodyl, senna, hemp seed pills, aloe), Dietary fiber (25-30g/day) + fluid intake >= 2L/day, 6 months) use of: Aluminum antacids, PPIs, calcium/bismuth supplements, Anticholinergics, or iron preparations. (20) Hypersensitivity to any study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SBM; | — |
Secondary
| Measure | Time frame |
|---|---|
| constipation Symptom Scale Assessment;Constipation Incidence;Number of Postoperative Glycerin Enema and Irrigation Uses;Postoperative Mean Daily Time per Defecation Episode;Postoperative Mean Daily Unsuccessful Defecation Attempts;Length of Hospital Stay;Incidence of Complications;Intraoperative and Postoperative Opioid Consumption; | — |
Countries
China
Contacts
Public ContactKang Pengde
West China Hospital of Sichuan University
Outcome results
None listed