Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids (THD/stapler)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Societa Italiana di Chirurgia ColoRettale.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Societa Italiana di Chirurgia ColoRettale
Information provided by:
Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier:
NCT00823784
First received: January 15, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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Purpose
Haemorrhoids have, in literature, extremely high ranges of prevalence, 4,4% to 36% and there is a debate on the best treatment for III degree hemorrhoids. The Stapled Hemorrhoidopexy is indicated in grade III haemorrhoids due to its advantages vs. other techniques in pain reduction and time before resume of normal activity. The new technique of Doppler guided trans-anal arterial ligation (THD) appear to be another important therapeutic tool thanks to its scarce complications, the minimally invasive procedure and efficacy of the short term results. The rationale of the two surgical techniques is different: in fact, the Stapled Hemorrhoidopexy is based on the hypothesis that the mucosal and sub/mucosal resection and stapling can cure the prolapse, etiologic factor of haemorrhoids; on the other hand, the interruption of the arterial inflow of hemorrhoids by THD reduces hemorrhoidal tissue." Aim of this study is to compare 2 techniques: The doppler guided transanal haemorrhoidal dearterialisation with the THD device and the stapled Haemorrhoidopexy (according to Longo) for III degree (Goligher) haemorrhoid, not regarding the number of prolapsed piles
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhoids |
Procedure: Transanal doppler hemorrhoidal ligation Procedure: stapled hemorrhoidopexy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Trial Comparing Transanal Doppler de-Arterialization (THD) Versus Stapler Operation for 3rd Degree Hemorrhoids |
Resource links provided by NLM:
Further study details as provided by Societa Italiana di Chirurgia ColoRettale:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction [ Time Frame: early postoperative period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1THD group
Series of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia
|
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
|
|
Active Comparator: 2 stapler group
135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy
|
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
|
Detailed Description:
After informed consent 284 patients with III degree hemorrhoids from 10 colorectal units will be randomized into two groups: stapler vs doppler guided transanal hemorrhoidal dearterialisation with the THD device.The early and long term outcome, as well as other secondary outcomes (costs, return to work and degree of satisfaction) will be recorded and compared.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00823784
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823784
Contacts
| Contact: Aldo Infantino, MD | ++39 3356862961 | ainfantino@libero.it |
Locations
| 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 | |
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
Investigators
| Study Chair: | Donato F Altomare, MD | Societa Italiana di Chirurgia ColoRettale |
More Information
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 |
| Study First Received: | January 15, 2009 |
| Last Updated: | January 15, 2009 |
| Health Authority: | Italy: National Institute of Health |
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 |
ClinicalTrials.gov processed this record on September 23, 2016