Text Size

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

This study has been completed.
Sponsor:
Information provided by:
East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00503269
First received: July 16, 2007
Last updated: October 16, 2008
Last verified: October 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Third degree haemorrhoids

Exclusion Criteria:

  • Unfit for day-surgery or general anaesthesia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by East Kent Hospitals University NHS Foundation Trust

Additional 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
Study First Received: July 16, 2007
Last Updated: October 16, 2008
Health Authority: United Kingdom: Research Ethics Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013