Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids (THD/stapler)
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ClinicalTrials.gov Identifier: NCT00823784 |
Recruitment Status
: Unknown
Verified January 2009 by Societa Italiana di Chirurgia ColoRettale.
Recruitment status was: Recruiting
First Posted
: January 16, 2009
Last Update Posted
: January 16, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhoids | Procedure: Transanal doppler hemorrhoidal ligation Procedure: stapled hemorrhoidopexy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 270 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Randomized Trial Comparing Transanal Doppler de-Arterialization (THD) Versus Stapler Operation for 3rd Degree Hemorrhoids |
Study Start Date : | January 2008 |
Estimated Primary Completion Date : | January 2009 |
Estimated Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1THD group
Series of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia
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Procedure: Transanal doppler hemorrhoidal ligation
THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy
Other Name: THD technique
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Active Comparator: 2 stapler group
135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy
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Procedure: stapled hemorrhoidopexy
Staple hemorrhoidopexy involves resection of a ring of low rectal mucosa an lifting the hemorrhoids up in the anal canal with a stapled suture
Other Name: Longo's technique
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- early complication rate (bleeding, pain) and long term outcome (symptomatic hemorrhoids recurrence) after stapled hemorrhoidopexy versus transanal hemorrhoid arteries ligation and mucopexy [ Time Frame: early postoperative period (30 days) and after 1 year ]
- Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction [ Time Frame: early postoperative period ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- III degree hemorrhoids
- both sex
- age between 18 and 70 years
- ability to understand the procedure
- written informed consent
Exclusion Criteria:
- previous surgery for hemorrhoids
- fecal incontinence
- obstructed defecation
- other active anorectic diseases
- irritable bowel syndrome

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): NCT00823784
Contact: Aldo Infantino, MD | ++39 3356862961 | ainfantino@libero.it |
Italy | |
Santa Maria dei Battuti Hospital | Recruiting |
S Vito al Tagliamento, PN, Italy, 33078 | |
Contact: Aldo Infantino, MD ++39 3356862961 ainfantino@libero.it | |
Principal Investigator: Aldo Infantino, MD |
Study Chair: | Donato F Altomare, MD | Societa Italiana di Chirurgia ColoRettale |
Publications:
Responsible Party: | Aldo Infantino, Societa Italiana di Chirurgia ColoRettale |
ClinicalTrials.gov Identifier: | NCT00823784 History of Changes |
Other Study ID Numbers: |
Siccr trial THD/stapler |
First Posted: | January 16, 2009 Key Record Dates |
Last Update Posted: | January 16, 2009 |
Last Verified: | January 2009 |
Keywords provided by Societa Italiana di Chirurgia ColoRettale:
hemorrhoids stapler Doppler |
artery ligation outcome recurrence |
Additional relevant MeSH terms:
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Vascular Diseases Cardiovascular Diseases |