COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00503269
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : October 17, 2008
Information provided by:
East Kent Hospitals University NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Hemorrhoidectomy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy
Study Start Date : July 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Third degree haemorrhoids

Exclusion Criteria:

  • Unfit for day-surgery or general anaesthesia.

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 identifier (NCT number): NCT00503269

Layout table for location information
United Kingdom
Channel day surgery unit
Ashford, Kent, United Kingdom, TN24 0LZ
Sponsors and Collaborators
East Kent Hospitals University NHS Foundation Trust
Layout table for investigator information
Principal Investigator: Nagesh G Rao, FRCS, MD East Kent NHS Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00503269    
Other Study ID Numbers: AA/dd
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008
Keywords provided by East Kent Hospitals University NHS Foundation Trust:
Local anaesthesia
Additional relevant MeSH terms:
Layout table for 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