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HemorrhoidsPhase 3THD/staplerNCT00823784

Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids

A Phase 3 study testing Transanal doppler hemorrhoidal ligation and stapled hemorrhoidopexy in people with Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hemorrhoids
What is being tested?
Transanal doppler hemorrhoidal ligation and stapled hemorrhoidopexy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteItaly
Study dates
Jan 2008to Jul 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • III degree hemorrhoids
  • both sex
  • age between 18 and 70 years
  • ability to understand the procedure
  • written informed consent

Who cannot join

  • previous surgery for hemorrhoids
  • fecal incontinence
  • obstructed defecation
  • other active anorectic diseases
  • irritable bowel syndrome

Trial locations and contacts

1 site in 1 country.

Aldo Infantino, MD contact

++39 3356862961

ainfantino@libero.it

Italy1 site, 1 recruiting

  • Santa Maria dei Battuti Hospital

    S Vito Al Tagliamento, PN, 33078

    Aldo Infantino, MD, ++39 3356862961, ainfantino@libero.it

    Aldo Infantino, MD

    Recruiting

Other trials in Italy

About this study

Official title: Prospective Randomized Trial Comparing Transanal Doppler de-Arterialization (THD) Versus Stapler Operation for 3rd Degree Hemorrhoids

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

Read the 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.

Conditions
Hemorrhoids
Being tested
Transanal doppler hemorrhoidal ligation, stapled hemorrhoidopexy
Keywords
hemorrhoids, stapler, Doppler, artery ligation, outcome, recurrence
Medical subject headings
Hemorrhoids, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transanal doppler hemorrhoidal ligationProcedure or surgery

    Also called THD technique

    THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy

  • stapled hemorrhoidopexyProcedure or surgery

    Also called Longo's technique

    Staple hemorrhoidopexy involves resection of a ring of low rectal mucosa an lifting the hemorrhoids up in the anal canal with a stapled suture

Study groups in NCT00823784
Study groupRoleWhat they receive
1THD groupExperimentalSeries of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia
Receives: Procedure: Transanal doppler hemorrhoidal ligation
2 stapler groupActive comparator135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy
Receives: Procedure: stapled hemorrhoidopexy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. early complication rate (bleeding, pain) and long term outcome (symptomatic hemorrhoids recurrence) after stapled hemorrhoidopexy versus transanal hemorrhoid arteries ligation and mucopexy

    Measured: early postoperative period (30 days) and after 1 year

Secondary outcomes (1)

  1. Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction

    Measured: early postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2009 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2009 (estimated)
  4. Study completionJul 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00823784
Sponsor's protocol ID
Siccr trial THD/stapler
Acronym
THD/stapler
Status last verified
Jan 2009
First submitted
15 Jan 2009
Last updated
16 Jan 2009
Results posted
No
Data monitoring committee
No

Publications

  • Dal Monte PP, Tagariello C, Sarago M, Giordano P, Shafi A, Cudazzo E, Franzini M. Transanal haemorrhoidal dearterialisation: nonexcisional surgery for the treatment of haemorrhoidal disease. Tech Coloproctol. 2007 Dec;11(4):333-8; discussion 338-9. doi: 10.1007/s10151-007-0376-4. Epub 2007 Dec 3.

    PubMed 18060529

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Transanal doppler hemorrhoidal ligation and stapled hemorrhoidopexy in people with Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aldo Infantino, MD (++39 3356862961, ainfantino@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00823784, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2009; AzTrials last refreshed its copy on 28 Oct 2026.

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