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Efficacy of transanal haemorrhoidal dearterialisation (THD) over diathermy excision in the treatment of grade ii and iii haemorrhoids
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SLCTR Registration Number
SLCTR/2010/003
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Efficacy of transanal haemorrhoidal dearterialisation (THD) over diathermy excision in the treatment of grade ii and iii haemorrhoids
Public Title of Trial
Efficacy of transanal haemorrhoidal dearterialisation (THD) over diathermy excision in the treatment of grade ii and iii haemorrhoids
Disease or Health Condition(s) Studied
Grade ii and iii haemorrhoids
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
To assess the outcome of THD over diathermy excision for 2nd and 3rd degree haemorrhoids ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The THD Doppler guided proctoscope is a system for the surgical treatment of hemorrhoids of second and third degree. The Doppler system, detects the terminal branches of the superior hemorrhoid artery, and are ligated through the proctoscope. The procedure is carried out transanally under spinal anaesthesia
Inclusion criteria
Patients presenting with 2nd or 3rd degree haemorrhoids
Exclusion criteria
Non-consenting patients. Emergency admissions. Pregnant women. Patients who have already undergone therapeutic procedures of the anal canal and/or rectum including therapy for haemorrhoids. Patients with inflammatory bowel disease or other chronic conditions of the ano-rectal region.
Primary outcome(s)
|
1.
To assess the efficacy of THD compared to diathermy excision for grade II and III haemorrhoids |
[ Post op day 1 , assessment on discharge and assessment at four months. ] |
Secondary outcome(s)
|
1.
To assess the relief of symptoms |
[ Post op day 1 , assessment on discharge and assessment at four months ] |
|
2.
To assess the effect on anal sphincter function |
[ Post op day 1 , assessment on discharge and assessment at four months ] |
|
3.
To assess return to normal activities and work |
[ Post op day 1 , assessment on discharge and assessment at four months ] |
|
4.
To assess the post-operative discomfort |
[ Post op day 1 , assessment on discharge and assessment at four months ] |
Target number/sample size
50
Countries of recruitment
Sri Lanka
Anticipated start date
2010-08-01
Anticipated end date
2011-08-01
Date of first enrollment
Date of study completion
Recruitment status
Suspended
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2010-05-12
Approval number
AA/ETH/2010
Details of Ethics Review Committee
| Name: | Ethics Review Committee, National Hospital of Sri Lanka |
| Institutional Address: | Colombo, Sri Lanka |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
D.N. Samarasekera
Professor of Surgery and Head of the Department
Department of Surgery, Faculty of Medicine, University of Colombo Kynsey road, Colombo 08
0112691111 Ext. 2173
0094112691581
samarasekera58@yahoo.co.uk
Contact Person for Public Queries
D.N. Samarasekera
Professor of Surgery and Head of the Department
Department of Surgery, Faculty of Medicine, University of Colombo Kynsey road, Colombo 08
0112691111 Ext. 2173
0094112691581
samarasekera58@yahoo.co.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
