This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
East Kent Hospitals University NHS Foundation Trust Identifier:
First received: July 16, 2007
Last updated: October 16, 2008
Last verified: October 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 Intervention
Hemorrhoids Procedure: Hemorrhoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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


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

Inclusion Criteria:

  • Third degree haemorrhoids

Exclusion Criteria:

  • Unfit for day-surgery or general anaesthesia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00503269

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00503269     History of Changes
Other Study ID Numbers: AA/dd
Study First Received: July 16, 2007
Last Updated: October 16, 2008

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

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on July 24, 2017