A multicentre, randomised controlled trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting (LaCeS2)

niversity of Leeds0 个研究点目标入组 512 人开始时间: 2022年2月9日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Aged =18 years
•2. Diagnosis of acute colorectal pathology requiring resectional surgery (for example; acute diverticular disease, inflammatory bowel disease, large bowel obstruction and colonic perforation) confirmed radiologically and/or endoscopically. A colorectal resection will be defined as surgery from the caecum to the anus
•3. Urgency of operation defined as per National Confidential Enquiry into Patient Outcome and Death (NCEPOD) guidelines as urgent: intervention for acute onset or clinical deterioration of potentially life-threatening conditions, for those conditions that may threaten the survival of limb or organ, for fixation of many fractures and for relief of pain or other distressing symptoms. Normally within hours of the decision to operate, subdivided into NELA categories of 2a (approx. 2-6 hours) or 2b (approx. 6-18 hours).
•4. Suitable for laparoscopic and open surgery
•5. Informed written consent obtained
•6. Able and willing to comply with the terms of the protocol including quality of life questionnaires

•1. Acute non-colorectal pathology (for example; adhesional small bowel obstruction, appendicitis, peptic ulcer disease)
•2. Hand-assisted laparoscopic surgery using a hand port
•3. Laparoscopy and peritoneal lavage alone for colorectal pathology
•4. Insertion of an endoscopic stent followed by laparoscopic resection for obstructing colorectal pathology
•5. Patients undergoing emergency surgery for complications of elective colorectal operations
•6. Pregnancy
•7. Pre-existing cognitive impairment affecting the patient’s capacity to consent

发起方

niversity of Leeds