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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
Sponsor:
Information provided by:
Societa Italiana di Chirurgia ColoRettale

Study Description
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Brief 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. 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 or disease Intervention/treatment Phase
Hemorrhoids Procedure: Transanal doppler hemorrhoidal ligation Procedure: stapled hemorrhoidopexy Phase 3

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction [ Time Frame: early postoperative period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

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


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
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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