aCeS Feasibility: Laparoscopic versus open colorectal surgery in the acute setting

Not Applicable

Completed

• Conditions: Specialty: Surgery, Primary sub-specialty: UKCRC code/ Disease: Surgery; Emergency laparoscopic surgery

• Registration Number: ISRCTN15681041
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-22
• Study Completion: 2018-05-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

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
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

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility: Quantitative assessment of recruitment rate, measured by numbers of patients screened, eligible and randomised each month.