Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thromboembolic events in major surgery? Protocol for a randomised clinical trial (IMPOSTERS).

INTRODUCTION: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits. METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals. TRIAL REGISTRATION NUMBER: ANZCTR12622001527752.

Antiseptic Skin Agents to Prevent Surgical Site Infection After Incisional Surgery: A Randomized, Three-armed Combined Non-inferiority and Superiority Clinical Trial (NEWSkin Prep Study).

OBJECTIVE: To compare SSI rates between the skin preparation agents: PI-Aq, povidone-iodine with alcohol (PI-Alc), and chlorhexidine with alcohol (C-Alc). BACKGROUND: Guidelines suggest that alcohol-containing chlorhexidine solutions are the gold standard for skin preparation before surgery. It remains difficult to determine whether it is the chlorhexidine component or the addition of alcohol that confers the most benefit. METHODS: We conducted a multicenter, prospective, combined non-inferiority (PI-Alc vs C-Alc) and superiority (PI-Alc vs PI-Aq) randomized clinical trial. Participants were randomized 1:1:1 to receive either C-Alc, PI-Alc, or PI-Aq. The primary outcome was SSI rate as defined by the Centers for Disease Control. Secondary outcomes were complication rates, length of hospital stay, readmissions, and skin reactions. RESULTS: Between January 2015 and December 2018, 3213 patients were randomized (C-Alc: 1076, PI-Alc: 1075, and PI-Aq: 1062). Mean age of participants was 57% and 55% were female. SSI rates were: C-Alc 11.09%, PI-Alc 10.88%, and PI-Aq 12.56%. PI-Alc was found to be non-inferior to C-Alc (mean difference, -0.21%; 95% confidence interval, -2.85 to 2.44; P = 0.0009 non-inferiority), whereas PI-Alc was not superior to PI-Aq (mean difference, -1.68%; 95% confidence interval, -4.40 to 1.05; P = 0.2302). There were no differences seen in secondary outcomes between groups and no treatment related adverse events or deaths occurred. CONCLUSIONS: PI-Alc is non-inferior to C-Alc and not superior to PI-Aq. This is at odds with current guidelines that suggest alcohol-based chlorhexidine solutions should routinely be used for surgical skin preparation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ANZCTRN12615000021571. www.anzctr.org.au.

Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial.

INTRODUCTION: Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. MATERIALS AND METHODS: A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. RESULTS: A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. CONCLUSION: We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.

Sham feeding with chewing gum after elective colorectal resectional surgery: a randomized clinical trial.

OBJECTIVE: To determine whether sham feeding with chewing gum improved gastrointestinal recovery after colorectal resection surgery, in the presence of routine postoperative feeding. BACKGROUND: Sham feeding with chewing gum has been shown to accelerate the return of gut function after colorectal surgery. This study sought to determine whether sham feeding with gum, after colorectal resection, accelerates return of gastrointestinal function in patients on a rapid feeding enhanced recovery program. METHODS: A randomized "two armed" controlled clinical trial was performed. Equal groups of open and laparoscopic colorectal resection surgical patients were recruited. Patients in the intervention arm received chewing gum 4 times a day postoperatively. All patients in the trial were placed on an established, standardized Enhanced Recovery After Surgery program. The primary outcome was time to return of gut function, assessed by time to flatus and first bowel motion. Secondary outcomes were time to tolerate diet, symptoms of ileus in the form of nausea, vomiting and distension, pain as assessed by analgesic consumption and visual analogue scales, complications, and length of hospital stay. RESULTS: A total of 161 patients were recruited. Postoperative morbidity was equivalent between groups, with no complications related to gum chewing. There was no difference between groups with respect to the primary outcomes of time to flatus and bowel motion. There was less perception of pain in the intervention group on days 2 to 5, and no difference with respect to all other secondary outcomes. CONCLUSIONS: Sham feeding with gum, after open and laparoscopic colorectal resectional surgery is safe, but does not hasten the return of gastrointestinal function in patients who receive accelerated postoperative feeding. (ACTRN12607000538448).