Local Anaesthetic Day-Care Haemorrhoidectomy Challenges Traditional Concepts - a Randomised Controlled Trial
Background: Local anaesthetic day-care open haemorrhoidectomy (LH) is feasible, cheap and may be the cost-effective surgical approach to third degree haemorrhoids. This prospective randomised controlled trial compares patient's evaluation of LH with general anaesthetic day-care Park's modified Milligan-Morgan haemorrhoidectomy (GH).
Methods: 41 patients with third degree haemorrhoids were randomised to LH (19 cases) and GH (22 cases). Demographics were comparable. Independent assessment (by a research nurse) and clinical evaluation ran parallel for 6 months. Outcome measures were average and expected pain scores for 10 days; satisfaction scores at 10 days, 6 weeks and 6 months. Secondary outcomes were journey time and cost in day surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy|
- Average pain and expectation score. [ Time Frame: 6 months ]
- Journey time and cost analysis [ Time Frame: 6 months. ]
|Study Start Date:||July 2005|
|Study Completion Date:||July 2007|
Active Comparator: 1
30 ml of 1% Lignocaine with 1:10,000 Adrenaline
Hemorrhoidectomy under local anaesthesia
Active Comparator: 2
Standard General anaesthesia with Enflurane and Propofol.
General anaesthetic haemorrhoidectomy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00503269
|Channel day surgery unit|
|Ashford, Kent, United Kingdom, TN24 0LZ|
|Principal Investigator:||Nagesh G Rao, FRCS, MD||East Kent NHS Trust|