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Local Anaesthetic Day-Care Haemorrhoidectomy Challenges Traditional Concepts - a Randomised Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503269
First Posted: July 18, 2007
Last Update Posted: October 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
East Kent Hospitals University NHS Foundation Trust
  Purpose

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 Intervention
Hemorrhoids Procedure: Hemorrhoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by East Kent Hospitals University NHS Foundation Trust:

Primary Outcome Measures:
  • Average pain and expectation score. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Journey time and cost analysis [ Time Frame: 6 months. ]

Enrollment: 42
Study Start Date: July 2005
Study Completion Date: July 2007
Arms Assigned Interventions
Active Comparator: 1
30 ml of 1% Lignocaine with 1:10,000 Adrenaline
Procedure: Hemorrhoidectomy
Hemorrhoidectomy under local anaesthesia
Active Comparator: 2
Standard General anaesthesia with Enflurane and Propofol.
Procedure: Hemorrhoidectomy
General anaesthetic haemorrhoidectomy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Third degree haemorrhoids

Exclusion Criteria:

  • Unfit for day-surgery or general anaesthesia.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
Channel day surgery unit
Ashford, Kent, United Kingdom, TN24 0LZ
Sponsors and Collaborators
East Kent Hospitals University NHS Foundation Trust
Investigators
Principal Investigator: Nagesh G Rao, FRCS, MD East Kent NHS Trust
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00503269     History of Changes
Other Study ID Numbers: AA/dd
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: October 17, 2008
Last Verified: October 2008

Keywords provided by East Kent Hospitals University NHS Foundation Trust:
Haemorrhoidectomy
Local anaesthesia

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents