How long before routine next-day discharge for primary hip and knee replacement patients in the United Kingdom?

Abstract

Objectives: Postoperative ileus is a common complication after colorectal resection. Targinact combines oral oxycodone with naloxone and may reduce opiate-induced gut dysfunction after colorectal surgery. We examined the feasibility of a randomised trial of Targinact within the context of an enhanced recovery (ER) perioperative protocol for laparoscopic colorectal resection in an NHS setting. Methods: This was a single-centre open-label phase II feasibility study. Patients were recruited and randomised to receive analgesia based on oral Targinact or Oxycodone, with the first dose given preoperatively. Careful adherence to a written ER protocol maximised experimental model consistency. Primary endpoints were recruitment, retention and protocol compliance. Secondary endpoints were recorded to explore definition of a composite endpoint for future studies of gut dysfunction after colorectal surgery. Results: Eighty two patients were screened over an eight month period resulting in 62 patients being randomised (76%). Only 2 eligible patients declined to participate. Attrition rate was 19% (12/62), the main reason being development of ineligibility between randomisation and surgery. There was 100% follow-up and retention of the modified intention to treat cohort of 50 patients (mean age 69, colon cancer in 49/50). Compliance with individual protocol elements (single-shot spinal anaesthetic, 12 hour IV lidocaine infusion, IV fluids stopped day 1, PCA removed day 1) was >85%. Fifteen of 23 patients in the control arm (65%) and 13 of 27 in the Targinact arm (48%) achieved return of gut function (tolerating diet, passage of flatus, postoperative nausea and vomiting score <4) by day 3 (p¼0.264). Time to first bowel movement was earlier in the Targinact group (87 vs. 11 hours, p¼0.03). Conclusion: Patient participation and retention was high. Attrition was mainly due to requirement for pre-rather than postoperative randomisation specific to this study design. Protocol compliance was high resulting in a consistent model to test perioperative interventions. Different trends in return of gut function were observed depending on the definition of the latter.