Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy
Randomised Controlled Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
This is a randomised trial to compare both the procedures and the difference in their immediate postoperative pain, recovery and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 14, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 29, 2011
November 1, 2011
1.9 years
April 14, 2011
November 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative pain relief
Visual Analogue Score (1 to 10) willbe used to quantitatively assess pain outcomes.
6 weeks post-operatively
Secondary Outcomes (2)
Quality of life
Immediately pre-operatively and again at 6 weeks post-operatively
analgesia consumption
6 weeks post-operatively
Study Arms (2)
Milligan-Morgan Haemorrhoidectomy
ACTIVE COMPARATORControl arm
Laser Haemorrhoidectomy
EXPERIMENTALThis new method of haemorrhoidectomy is being compared to the standard Milligan-Morgan Haemorrhoidectomy.
Interventions
The intervention comprises laser haemorrhoidectomy This procedure will be performed under local anaesthetic with sedation as a day case The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser. Pre-operative local anaesthesia will be given
Eligibility Criteria
You may qualify if:
- Are fit enough to undergo general anaesthesia
- Are between the age of 18 and 80 years
- Are able and willing to provide informed consent
- Show no preference to either operative procedure and agree to randomization
- No contra-indications to receiving laser treatment
You may not qualify if:
- Are not fit enough to undergo a general anaesthesia
- Are not over the age of 18 years
- Are unable or unwilling to provide informed consent
- Have stated their operation preference
- Have any contra-indication preventing them from receiving laser treatment
- Have a history of non-compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Linconshire & Goole NHS Foundation trust
Goole, North Lincolnshire, DN14 6RX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Moore, MD, FRCS
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Surgeon
Study Record Dates
First Submitted
April 14, 2011
First Posted
April 27, 2011
Study Start
December 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 29, 2011
Record last verified: 2011-11