Local Anaesthetic Day-Care Haemorrhoidectomy Challenges Traditional Concepts - a Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT00503269|
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : October 17, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Procedure: Hemorrhoidectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy|
|Study Start Date :||July 2005|
|Actual 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
- Average pain and expectation score. [ Time Frame: 6 months ]
- Journey time and cost analysis [ Time Frame: 6 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503269
|Channel day surgery unit|
|Ashford, Kent, United Kingdom, TN24 0LZ|
|Principal Investigator:||Nagesh G Rao, FRCS, MD||East Kent NHS Trust|