ISRCTN15681041
Completed
未知
A multicentre, randomised controlled feasibility trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting
eeds Teaching Hospitals NHS Trust0 sites64 target enrollmentApril 22, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eeds Teaching Hospitals NHS Trust
- Enrollment
- 64
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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