Efficacy of transanal haemorrhoidal dearterialisation (THD) over diathermy excision in the treatment of grade ii and iii haemorrhoids

• Register: SLCTR
• Last refreshed on: 27 May 2013
• Main ID: SLCTR/2010/003
• Date of registration: 21/05/2010
• Primary sponsor: Prof. D.N. Samarasekera
• Public title: Efficacy of transanal haemorrhoidal dearterialisation (THD) over diathermy excision in the treatment of grade ii and iii haemorrhoids
• Scientific title: Efficacy of transanal haemorrhoidal dearterialisation (THD) over diathermy excision in the treatment of grade ii and iii haemorrhoids
• Date of first enrolment: 1/8/2010
• Target sample size: 50
• Recruitment status: Suspended
• URL: http://www.slctr.lk/trial_details.asp?reg_id={262551B8-D8E0-4040-83D7-54E44ED5F9BA}
• Study type: Interventional
• Study design: 50 patients with Grade II and III haemorrhoids will be selected for the study. Among them 25 patients will be randomly selected for the THD method. Other 25 patients will be subjected to diathermy excision (which is a standard surgical procedure). Primary end point of surgery for both groups of the study is the cessation of per rectal bleeding due to haemorrhoids. Secondary end points are the cessation of discharge, pruritus and pain. Expected duration of the study is 1 year. Both groups of patients following the procedure (i.e. diathermy excision and THD procedure) will be followed up at 4 months and 8 months post operatively

Countries of recruitment

Sri Lanka

Contacts

• Name: D.N. Samarasekera
• Affiliation: Professor of Surgery and Head of the Department

• Name: D.N. Samarasekera
• Affiliation: Professor of Surgery and Head of the Department

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Grade ii and iii haemorrhoids

Intervention(s)

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.

Primary Outcome(s)

To assess the efficacy of THD compared to diathermy excision for grade II and III haemorrhoids..

Secondary Outcome(s)

1.To assess the relief of symptoms

2.To assess the post-operative discomfort

3.To assess return to normal activities and work

4.To assess the effect on anal sphincter function
Of each treatment modality

Secondary ID(s)

nil known

Source(s) of Monetary Support

None