Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy
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|ClinicalTrials.gov Identifier: NCT01615575|
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : June 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Haemorrhoids||Procedure: Transanal haemorrhoidal dearterialisation Procedure: Stapler haemorrhoidopexy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Active Comparator: Haemorrhoidal dearterialisation
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.
Procedure: Transanal haemorrhoidal dearterialisation
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy
Active Comparator: Stapler haemorrhoidopexy
Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)
Procedure: Stapler haemorrhoidopexy
Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).
- Recurrence [ Time Frame: 42 months ]A telephone interview with a structured questionnaire at a median follow-up of 42 months.
- Postoperative pain [ Time Frame: 24 hr ]Pain score 24 hr after operation
- Complications [ Time Frame: One month ]Intra and postoperative complication within 30 days.
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 ClinicalTrials.gov identifier (NCT number): NCT01615575
|United Arab Emirates|
|The City Hospital|
|Dubai, United Arab Emirates, P O Box 505004|
|Principal Investigator:||Pierino Lucarelli, MD, FRCS|