Excisional HemorrhoidectomyNCT01264835

Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

A study testing Slotted Anoscope in people with Excisional Hemorrhoidectomy, run by Ethicon Endo-Surgery at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Excisional Hemorrhoidectomy
What is being tested?: Slotted Anoscope
Type of treatment: Medical device
How many people: 2 participants
Where: 3 sitesUnited States
Study dates: Dec 2010to Jun 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are at least 18 years of age
Are willing to give consent and comply with evaluation and treatment schedule
Meet institutional criteria for excisional hemorrhoidectomy
Are able to understand and complete study questionnaires.

Who cannot join

Previous Hemorrhoid surgery
Chronic daily narcotic use
Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure
Internal hemorrhoids that may be suitable for office management (surgeon discretion)
Fecal or urinary incontinence
Inflammatory Bowel Disease (Crohns, ulcerative colitis)

Show all 9Show fewer

Acutely thrombosed hemorrhoids (surgeon discretion)
Evidence of acute sepsis or the presence of a fistula
Anal stricture.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of South Alabama
Mobile, Alabama, 36693

Other trials in United States

About this study

Conditions: Excisional Hemorrhoidectomy
Being tested: Slotted Anoscope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Slotted AnoscopeDevice
SA411

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedure Duration (Surgery Time)
Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.
Measured: Time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jun 2011

First posted22 Dec 2010 (estimated)
Study startDec 2010
Primary completionJun 2011
Study completionJun 2011

Why it stopped: Slow Enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Excisional HemorrhoidectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01264835
Sponsor's protocol ID: CI-10-0003
Status last verified: Feb 2012
First submitted: 17 Dec 2010
Last updated: 2 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Minimaly Ivnasive Surgery for Grade III Hemorrhoids
Hemorrhoidectomy, Minimally Invasive Surgical Technique
Active, not recruitingObservational study
Definition and Validation of HeQAS for the Assessment of Technical Quality in Excisional Hemorrhoidectomy
Hemorrhoidectomy, Hemorrhoid
Active, not recruiting
Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy
Hemorrhoidal Disease, Hemorrhoid Pain
Not yet recruiting
Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Grade III-IV Mixed Hemorrhoids
Mixed Hemorrhoids

All Excisional Hemorrhoidectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy
ClinicalTrials.gov ID: NCT01264835
Acronym / sponsor ID: CI-10-0003
Conditions: Excisional Hemorrhoidectomy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow Enrollment
Enrolment: 2 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 22 Dec 2010 (estimated)
Results: Posted 2 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Are at least 18 years of age
Are willing to give consent and comply with evaluation and treatment schedule
Meet institutional criteria for excisional hemorrhoidectomy
Are able to understand and complete study questionnaires.

Key exclusion criteria (9 listed)

Previous Hemorrhoid surgery
Chronic daily narcotic use
Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure
Internal hemorrhoids that may be suitable for office management (surgeon discretion)
Fecal or urinary incontinence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Slotted AnoscopeSA411	Device	–

Primary outcome

Procedure Duration (Surgery Time)
Time frame: Time of surgery
Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.

Results and safety

Results posted to the registry on 2 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Slotted Anoscope	2	1

Primary outcome: Procedure Duration (Surgery Time)

Time frame: Time of surgery. Mean (Standard Deviation). Unit: minutes

Population analysed: No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Slotted Anoscope	1 of 2 (50%)	0 of 2 (0%)	Not reported

Limitations and caveats (from the sponsor): No analyses are being reported for the primary outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Excisional Hemorrhoidectomy

RecruitingObservational study
Minimaly Ivnasive Surgery for Grade III Hemorrhoids
Hemorrhoidectomy, Minimally Invasive Surgical Technique
Active, not recruitingObservational study
Definition and Validation of HeQAS for the Assessment of Technical Quality in Excisional Hemorrhoidectomy
Hemorrhoidectomy, Hemorrhoid
Active, not recruiting
Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy
Hemorrhoidal Disease, Hemorrhoid Pain
Not yet recruiting
Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Grade III-IV Mixed Hemorrhoids
Mixed Hemorrhoids

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Slotted Anoscope in people with Excisional Hemorrhoidectomy, run by Ethicon Endo-Surgery at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Duration (Surgery Time) (time frame: Time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01264835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.