NCT00823784

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 15, 2009

Last Update Submit

January 15, 2009

Conditions

Hemorrhoids

Keywords

hemorrhoidsstaplerDopplerartery ligationoutcomerecurrence

Outcome Measures

Primary Outcomes (1)

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

    early postoperative period (30 days) and after 1 year

Secondary Outcomes (1)

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

    early postoperative period

Study Arms (2)

1THD group

EXPERIMENTAL

Series of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia

Procedure: Transanal doppler hemorrhoidal ligation

2 stapler group

ACTIVE COMPARATOR

135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy

Procedure: stapled hemorrhoidopexy

Interventions

Transanal doppler hemorrhoidal ligationPROCEDURE

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

Also known as: THD technique
1THD group
stapled hemorrhoidopexyPROCEDURE

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

Also known as: Longo's technique
2 stapler group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Maria dei Battuti Hospital

S Vito Al Tagliamento, PN, 33078, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18060529BACKGROUND

MeSH Terms

Conditions

HemorrhoidsRecurrence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Donato F Altomare, MD

    Societa Italiana di Chirurgia ColoRettale

    STUDY CHAIR

Central Study Contacts

Aldo Infantino, MD

CONTACT

++39 3356862961ainfantino@libero.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

July 1, 2009

Last Updated

January 16, 2009

Record last verified: 2009-01

Locations

IT(1)