ISRCTN15681041已完成未知
A multicentre, randomised controlled feasibility trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting
eeds Teaching Hospitals NHS Trust0 个研究点目标入组 64 人开始时间: 2016年4月22日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29472259 protocol (added 04/02/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32573782/ results (added 03/03/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36417312/ (added 19/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged = 18 years old
- •2. Diagnosis of acute colorectal pathology requiring resectional surgery (including acute diverticular disease, inflammatory bowel disease, large bowel obstruction and colonic perforation) confirmed on CT scan
- •3. NCEPOD classification urgency. Defined as intervention for acute onset or clinical deterioration of potentially life-threatening conditions, for those conditions that may threaten the survival of limb or organ. Normally within hours of decision to operate. Subdivided into NELA categories of 2a (approx. 2-6 hours) or 2b (approx. 6-18 hours)
- •4. Suitable candidate for surgery as judged by the operating surgeon.
- •5. Suitable for laparoscopic and open surgery in the opinion of the operating surgeon.
- •6. Suitable for laparoscopic and open surgery in the opinion of the anaesthetist.
- •7. Informed written consent obtained
- •Qualitative Patient Inclusion Criteria
- •1. Approached to consider entry into the LaCeS trial and either
- •1.1. Agreed to participate in the trial
- •1.2. Decided against participation after randomisation
- •1.3. Decided against participation when study presented to them
- •2. Willing and able to comply with requirements of this sub-study
- •3. Written informed consent obtained to participate in this sub-study
- •Qualitative Healthcare Professional Interview Inclusion criteria
- •1. Healthcare professional at a site taking part in the LaCeS trial either:
- •1.1. Recruiting staff involved in the LaCeS trial
- •1.2. Local Principal Investigator involved in the LaCeS trial
- •1.3. Local clinical staff involved in the LaCeS trial
排除标准
- •1. Haemodynamic instability requiring inotropic support
- •2. Acute non-colorectal pathology (for example; small bowel obstruction, appendicitis, peptic ulcer disease ).
- •3. Hand-assisted laparoscopic surgery.
- •4. Laparoscopy and peritoneal lavage alone for colorectal pathology.
- •5. Insertion of an endoscopic stent followed by laparoscopic resection for colorectal pathology.
- •6. Patients undergoing surgery for complications of elective colorectal operations
- •7. Pregnancy
- •8. Pre-existing cognitive impairment
- •9. Currently participating in another surgical trial
- •Qualitative Patient Exclusion Criteria
- •1. Decline participation in this sub-study
- •2. Unable to comply with requirements of this sub- study protocol
- •Healthcare Professional Exclusion Criteria
- •Refusal to participate in this sub-study
研究者
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