Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids - Full Text View

Sponsor:	Societa Italiana di Chirurgia ColoRettale
Information provided by:	Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier:	NCT00823784

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:

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

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

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:

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. Epub 2007 Dec 3.

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 May 24, 2012