Specialty: Surgery, Primary sub-specialty:
Conditions
Interventions
The intervention being assessed is the use of laparoscopic surgery for the treatment of acute colorectal pathology requiring resectional surgery, in the unplanned, acute setting. This involves the use
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: Quantitative assessment of recruitment rate, measured by numbers of patients screened, eligible and randomised each month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility: 1.1. Practicality and acceptability of proposed recruitment and randomisation methods, assessed through qualitative patient and healthcare professional interviews and patient feedback questionnaires Feasibility of data collection required for a future phase III trial measured by the proportion of randomised patients with all the required baseline and follow-up assessments completed, number of withdrawals from follow-up data collection, reasons for withdrawal and number of losses to follow-up 1.2. Test and finalise the eligibility criteria to ensure homogeneity for a definitive phase III trial assessed by variability in baseline characteristics of randomised patients and queries that have arisen in relation to the eligibility criteria 1.3. Practicality and success of the blinding proposals in the acute setting assessed using the Bang Blinding Index for each arm, timings of unblindings, and through patient and healthcare professional interviews 2. Safety: Quantitative assessment of the safety profile of emergency laparoscopic colorectal surgery as measured by, conversion rates, intra- and post-operative complication rates, patient safety indicators rates and 30 day mortality rates 3. Endpoint Evaluation: 3.1. Establish the optimal outcome measure and it’s timing to use as a primary endpoint, and also suitable secondary endpoints for evaluation in a phase III randomised controlled trial by measuring the variability of candidate primary and secondary endpoints (including HrQoL scores, pain scores, re-operative rates, re-admission rates, patient safety indicators, complication rates, mortality rates, length of hospital stay, restoration of gastrointestinal function) at candidate time-points (3, 7 and 30 days and 3, 6 and 12 months post-surgery and completion rates of candidate endpoints at candidate time points 3.2. Evaluation of optimal measures of safety assessed by variability and completion rates of measures of safety and full description of saf | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactKatie Gordon
Outcome results
None listed