NCT01615575

Brief Summary

The aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV haemorrhoids with a long-term follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

3.5 years

First QC Date

June 4, 2012

Last Update Submit

June 7, 2012

Conditions

Haemorrhoids

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    A telephone interview with a structured questionnaire at a median follow-up of 42 months.

    42 months

Secondary Outcomes (2)

  • Postoperative pain

    24 hr

  • Complications

    One month

Study Arms (2)

Haemorrhoidal dearterialisation

ACTIVE COMPARATOR

Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.

Procedure: Transanal haemorrhoidal dearterialisation

Stapler haemorrhoidopexy

ACTIVE COMPARATOR

Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)

Procedure: Stapler haemorrhoidopexy

Interventions

Transanal haemorrhoidal dearterialisationPROCEDURE

Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy

Haemorrhoidal dearterialisation
Stapler haemorrhoidopexyPROCEDURE

Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).

Stapler haemorrhoidopexy

Eligibility Criteria

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

You may qualify if:

  • grade III and IV hemorrhoids requiring hemorrhoidectomy.

You may not qualify if:

  • first and second degree hemorrhoids
  • patients with firm and fibrotic external irreducible haemorrhoids
  • thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment
  • history of inflammatory bowel disease; history of colon, rectal or anal cancer
  • inability to give informed consent
  • age \< 18 years
  • pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The City Hospital

Dubai, P O Box 505004, United Arab Emirates

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pierino Lucarelli, MD, FRCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 8, 2012

Study Start

October 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

AE(1)