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

NCT00503269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Hemorrhoidectomy

Hemorrhoidectomy under local anaesthesia

PROCEDURE

Hemorrhoidectomy

General anaesthetic haemorrhoidectomy

Sponsors & Collaborators

  • East Kent Hospitals University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Nagesh G Rao, FRCS, MD · East Kent NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-06-30
Completion
2007-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503269 on ClinicalTrials.gov