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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
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014