待機的低侵襲大腸手術における連続創部浸潤対プラセボ(CIMICS):ランダム化比較試験の試験プロトコル
Sofie Glazemakers1,2, Stijn H J Ketelaers1, Harm J Scholten3
1Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.
Background:
Enhanced Recovery After Surgery (ERAS) programs emphasize multimodal analgesia to minimize opioid use and improve patient outcomes. Continuous wound infiltration (CWI) with local analgesic is a promising adjunct to multimodal analgesia. However, its benefits in minimally invasive procedures and ERAS-adherent care remain unknown. This trial investigates whether the addition of CWI to standard ERAS care improves postoperative recovery following minimally invasive colorectal surgery.
Methods:
In this single-centre, blinded, randomised controlled trial, 192 eligible patients are randomised to receive either a CWI system with bupivacaine 0.125% (the interventional arm), or a placebo CWI with physiological saline (the control arm). All patients receive standardized ERAS perioperative care with multimodal analgesia. The primary outcome is the Quality of Recovery-15 score (QoR-15NL) on postoperative day 2. Secondary outcomes include QoR-15NL and pain scores (postoperative days 1-5), opioid consumption, length of hospital stay, key functional recovery milestones, and 90-day postoperative complications.
Discussion:
This will be the first randomised controlled trial evaluating the effect of CWI within minimally invasive and ERAS-adherent colorectal surgery. The trial findings may improve evidence-based perioperative care guidelines and enhance postoperative multimodal analgesia.
関連する概念動画
The Placebo Effect
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Trial and Error and Algorithm
Continuing Care


