Local Anaesthetic Day-care Haemorrhoidectomy Challenges Traditional Concepts - a Randomised Controlled Trial
Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedSeptember 14, 2023
September 1, 2023
1.9 years
July 16, 2007
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average pain and expectation score.
6 months
Secondary Outcomes (1)
Journey time and cost analysis
6 months.
Study Arms (2)
1
ACTIVE COMPARATOR30 ml of 1% Lignocaine with 1:10,000 Adrenaline
2
ACTIVE COMPARATORStandard General anaesthesia with Enflurane and Propofol.
Interventions
Eligibility Criteria
You may qualify if:
- Third degree haemorrhoids
You may not qualify if:
- Unfit for day-surgery or general anaesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Channel day surgery unit
Ashford, Kent, TN24 0LZ, United Kingdom
Related Publications (1)
Kushwaha R, Hutchings W, Davies C, Rao NG. Randomized clinical trial comparing day-care open haemorrhoidectomy under local versus general anaesthesia. Br J Surg. 2008 May;95(5):555-63. doi: 10.1002/bjs.6113.
PMID: 18389499DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nagesh G Rao, FRCS, MD
East Kent NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 18, 2007
Study Start
July 1, 2005
Primary Completion
June 1, 2007
Study Completion
July 1, 2007
Last Updated
September 14, 2023
Record last verified: 2023-09